Lyme Disease Vaccine (VLA15)

Why Does Lyme Disease Affect Specific Individuals

Karen McClorey Hackett — Thu, 24 Apr 2025 08:56:23 +0000

Reviewer:

As the northeastern United States prepares for another Lyme disease season without an approved vaccine, more individuals are at increased risk of both acute Lyme disease (caused by B. burgdorferi infection) and postacute sequelae after Lyme disease.

Lyme disease has been a notifiable condition since 1991. Last year, approximately 89,000 cases were reported in the U.S., in states such as Pennsylvania.

To help understand the impact of this tick-transmitted disease, the journal Science Translational Medicine published two insightful studies.

Published on April 23, 2025, these studies investigate not only why Lyme disease continues to affect specific individuals but also which antibiotics are most effective in treating the disease.

One study offers insights into the presence of antigens from bacterial remnants transported to the liver, shedding light on the mechanisms behind the disease's persistence.

McClune et al. investigated how the B. burgdorferi peptidoglycan (PGBb) may contribute to the long-term consequences of Lyme disease. They observed that a particular form of PGBb could persist in the mouse liver for much longer than others, or even peptidoglycan from different bacteria, suggesting that PGBb could serve as a source of continuous antigen, thereby driving inflammation.

The other study rigorously evaluates approved antibiotics, aiming to identify a safer and more effective alternative that can be administered at a lower dose than the standard treatment, doxycycline.

Piperacillin emerged as a compound that eradicated B. burgdorferi at low-nanomolar concentrations by specifically interfering with the unusual, multizonal peptidoglycan synthesis pattern common to the Borrelia clade.

Mechanistic in vitro studies identified the cellular target of piperacillin in B. burgdorferi, producing key insights that may explain both the specificity and efficacy of the compound.

Furthermore, in vivo studies using an experimental mouse infection model showed that piperacillin-treated animals received a 100-fold lower dose than the effective dose of doxycycline without affecting the murine microbiome.

These findings suggest that piperacillin may provide clinicians with an additional therapeutic option for Lyme disease.

These researchers wrote, 'By enhancing our understanding and opening the door to alternative treatment options, we may be able to improve outcomes for those battling this challenging illness.'

'Together, these findings could revolutionize our approach to Lyme disease, offering new hope for the millions affected in the United States each year,' the researchers concluded.

Shortly, an innovative Lyme disease vaccine candidate that is conducting late-stage clinical trials could become available in the U.S. But its pending approval will not be in time for use during the 2025 season.

Sub Title:

Lyme disease cases reported in Northeast United States

References:

The peptidoglycan of Borrelia burgdorferi can persist in discrete tissues and cause systemic responses consistent with chronic i

A high-resolution screen identifies a preexisting beta-lactam that specifically treats Lyme disease in mice

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Parasitizing Birds Bring More than Lyme Disease

Karen McClorey Hackett — Wed, 20 Nov 2024 20:38:20 +0000

Reviewer:

Robert Carlson, MD

Ticks are very effective disease vectors, connecting humans to diseases in wild reservoirs like Lyme disease. Although mammals commonly serve as hosts for ticks, they typically travel relatively short distances before ticks complete their blood meal and drop off.

However, parasitizing birds, especially migratory birds, allows them to travel very long distances.

For example, the Asian long-horned tick was first detected in New Jersey in 2017 and has since been found in 14 other states.

“Geographic distribution is changing very rapidly in many tick species,” said Dr. Lorenza Beati of Georgia Southern University, a co-author of a related study, in a press release on November 18, 2024.

“For some migrating exotic ticks, global warming may create conditions at their northern destination similar to their usual range. If warmer climatic conditions are combined with the presence of suitable vertebrate hosts for all tick life stages, the chance of establishment is going to increase.”

To investigate tick dispersal through migrating birds, scientists set up nets at six locations where birds stop to rest along the northern Gulf of Mexico. Each bird was ringed with a band carrying an identification number, measured, and examined to check its physical condition and look for ticks.

When ticks were found, these were removed and preserved for later DNA analysis to confirm the species and identify the micro-organisms they carried.

The scientists divided the birds into three categories — residents, short-distance migrants, and long-distance migrants – and mapped out the different species’ geographic distributions to understand where they could have picked up ticks.

This highlighted how far ticks could be carried: mean dispersal distances rose as high as 5000km.

However, parasitism turned out to be relatively low.

Nearly 15,000 birds were sampled, almost 2,000 more than once, yet only 421 ticks were collected from 164 birds.

Although 18 different species of tick were identified — including several neotropical species not established in the US — just four species accounted for 81% of the ticks identified by the scientists.

This study found that short-distance migrants carried more ticks than long-distance migrants.

The scientists then analyzed the bacteria carried by the ticks.

The most common bacteria were Francisella, endosymbionts that help ticks function. Higher levels of Francisella bacteria in a tick have previously been associated with lower levels of Rickettsia or Cutibacterium.

The second most abundant bacteria were Rickettsia species, which could indicate that they have a symbiotic relationship with ticks, which is currently unknown to us.

Parasitizing migrating birds, which travel long distances, demands significant energy expenditure from the ticks attached to the birds: it may be that the Rickettsia species help them cope somehow.

Some species of Rickettsia can cause diseases in humans, including spotted fevers, but we don’t yet know if invasive species of ticks are likely to transmit these diseases to humans.

The scientists explained ....“Not only could these ticks bring new pathogens, but if they manage to establish themselves in the US, they could become additional vectors of pathogens already present in this country or maintain pathogens in wildlife reservoirs, which can then become sources of infection,” said Karim.

He recommended that people protect themselves with insect repellent and check for ticks after walking in tick-infested areas.

While no vaccines are available for these exotic diseases, recent announcements indicate the first Lyme disease vaccine may become available in 2026.

Sub Title:

Lyme disease vaccine candidate is conducting late stage research

Reference:

Ticks without borders: microbiome of immature neotropical tick species parasitizing migratory songbirds along northern Gulf of M

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Preparing Lyme Disease Defense Starts Now

Karen McClorey Hackett — Sun, 22 Sep 2024 16:40:03 +0000

Reviewer:

Robert Carlson, MD

Without an approved Lyme disease vaccine, a bacterial tickborne disease continues to spread in Europe and the United States. Lyme disease cases were initially detected in Lyme, Connecticut, and are now the most common vectorborne disease.

Lyme disease cases have increased by over 100% during the past few years.

According to the U.S. Centers for Disease Control and Prevention (CDC) Tick Bite dashboard on September 22, 2024, most people are infected in the northeast and midwest areas of the U.S., and peaking around the month of May each year.

Specifically, Lyme disease is most often detected in young and older people.

While most Lyme disease patients recover after treatment, about 5 to 10% can have prolonged symptoms, such as fatigue, pain, and difficulty thinking, as a result of their infection.

Some patients are concerned that their long-term symptoms may be due to Lyme disease and may take potentially harmful treatments, such as extended courses of antibiotics, says the CDC.

In partnership with the CDC, the American Medical Association developed a new information toolkit to assist clinicians in providing better patient care.

During a COCA Call on September 19, 2024, presenters Erica Kaufman West, MD, FACP, FIDSA, and Grace Marx, MD, MPH, FIDSA, shared an overview of Lyme disease, provided a diagnostic and management framework for patients with prolonged symptoms and concerns about Lyme disease, and reviewed new clinical tools and resources to help support these patients.

From a prevention perspective, there are no Lyme disease-approved vaccines as of late September 2024.

However, Valneva SE's VLA15 vaccine candidate has advanced the furthest along the clinical development timeline, with two Phase 3 trials in progress.

The latest results from the VLA15-221 Phase 2 study demonstrated a significant anamnestic antibody response across all six serotypes covered by the vaccine candidate in pediatric and adolescent participants, as well as in adults, measured one month after administration of this second booster dose (month 31).

A high proportion of participants seroconverted after the second booster dose, yielding seroconversion rates (SCRs) above 90% for all outer surface protein A (OspA) serotypes in all age groups, in line with SCRs after the first booster.

Geometric Mean Titers were comparably high one month after the first and second booster (i.e., month 19 vs. month 31).

On September 3, 2024, Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented in a press release, "We are encouraged by these (phase 3) data, which support the potential benefit of booster doses across all examined age groups. Each new set of positive data brings us one step closer to potentially bringing this vaccine to adults and children living in areas where Lyme disease is endemic."

Subject to positive phase 3 study data, Valneva and its co-developer Pfizer Inc. could submit a Biologics License Application to the U.S. FDA as early as 2025 and a Marketing Authorization Application to the European Medicines Agency in 2026,

Sub Title:

VLA15 is the most advanced Lyme disease vaccine candidate in 2024

Reference:

US CDC - Clinical Tools and Resources to Support Patients with Prolonged Symptoms and Concerns about Lyme Disease

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CDC Tick Bite dashboard 19, 2024

Who Gets Lyme Disease

Karen McClorey Hackett — Thu, 15 Aug 2024 09:42:04 +0000

Reviewer:

Robert Carlson, MD

In the United States, recent studies suggest that approximately 476,000 people are diagnosed with Lyme disease (LD) each year. But who are these people?

The U.S. Centers for Disease Control and Prevention published a study in Emerging Infectious Diseases indicating that most LD diagnoses in the United States occurred during the summer, primarily among older men and individuals living in high-incidence states.

Furthermore, on August 14, 2024, the CDC reported (Volume 30, Number 9—September 2024) that the overall incidence of LD was about seven times higher than that reported through public health surveillance.

About 82% of LD diagnoses occurred in high-incidence states by men aged 65–69 years.

A total of 56.1% of LD cases were diagnosed in men per Medicare data, while 60.4% in men were represented in surveillance data.

In surveillance data, women had a higher rate than men among those aged 75 to 79 in low incidence areas.

Lyme disease is caused by the bacterium Borrelia burgdorferi and, rarely, Borrelia mayonii. It is transmitted to humans through the bite of infected Ixodes ticks.

These new findings align with previous CDC reports.

These researchers wrote, 'When comparing Medicare and surveillance data, the seasonality of LD differed by region: high-incidence states and neighboring states exhibited similar patterns for diagnoses and surveillance cases, but low-incidence states demonstrated a more muted peak for LD diagnoses in summer.'

From a disease prevention perspective, there is good news on the horizon.

On July 17, 2024, Pfizer Inc. and Valneva SE announced that the “Vaccine Against Lyme for Outdoor Recreationists” clinical study had completed the primary vaccination series (three doses) of VLA15, a multivalent recombinant protein vaccine. It is designed for prophylactic, active immunization against LD to protect people against most human pathogenic Borrelia species.

Subject to positive data, VLA15 could be the first Lyme disease vaccine to become commercially available.

Following successful clinical research, Pfizer plans to submit a Biologics License Application to the U.S. FDA and a Marketing Authorization Application to the European Medicines Agency in 2026 for VLA15's authorization.

Sub Title:

Lyme disease vaccine availability pending until 2026

Reference:

CDC - Epidemiology of Lyme Disease Diagnoses among Older Adults, United States, 2016–20191

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US CDC Volume 30, Number 9—September 2024

Ticks Are Tiny Lyme Disease Carriers

Karen McClorey Hackett — Fri, 09 Aug 2024 16:56:50 +0000

Reviewer:

Robert Carlson, MD

With nearly 900 species of ticks identified globally, their impact on human health is becoming increasingly concerning. Unfortunately, the northeastern United States has become a prime area for these disease-carrying ticks.

According to a study published by the journal Ticks and Tick-borne Diseases in November 2023, there are 20 tick-borne diseases found in the U.S.

Over time, the black-legged (deer) tick that carries Lyme disease has spread across several states. As its name implies, this disease was first identified in Lyme, Connecticut, and has spread west to states such as Minnesota.

The good news for hikers and campers is that getting bitten by a tick doesn't guarantee you'll become infected with a disease. Most pathogens can only be transmitted if a tick feeds on a host for a particular duration.

In the case of Lyme disease, the risk of illness following a tick bite is 1-5%.

The U.S. Centers for Disease Control and Prevention (CDC) reports that approximately 30,000 to 50,000 cases of Lyme disease are reported in the U.S. each year, with 95% of cases occurring in 15 states.

However, it is estimated that as many as 475,000 people could be infected with Lyme disease annually.

Lyme disease is caused by the Borrelia burgdorferi bacteria, which evades the immune system at the tick bite, leading to flu-like symptoms. Certain strains of the bacteria can cause more severe symptoms, such as neurological and cardiac issues, which occur in about 5% of Lyme cases.

The CDC suggests several ways to prevent tick bites, such as spraying insecticide on clothing and boots, using repellents such as DEET, and checking for ticks after spending time outdoors.

Shower promptly after being in tick habitats—within 2 hours—to help wash off crawling ticks.

Tumble dry clothing on high to kill ticks in clothing. Ticks do not like low humidity levels in homes and will rapidly desiccate and die if they cannot find a host.

According to recent news, a human vaccine for Lyme disease is conducting late-stage phase 3 clinical trials, with expected completion in 2025.

The VLA15 vaccine candidate is a multivalent recombinant protein vaccine targeting Borrelia's outer surface protein A. The U.S. Food and Drug Administration (FDA) granted the VLA15 vaccine development program Fast Track designation.

Recently, Valneva SE and Pfizer, Inc. began collaborating on VLA15's development and commercialization.

Juan Carlos Jaramillo, M.D., Chief Medical Officer, Valneva, said in a press release on July 17, 2024, "We are pleased to see the progress of our Phase 3 VALOR trial. Lyme disease is the most prevalent vector-borne disease in the United States and Europe. It can result in debilitating complications and extensive healthcare treatments."

"Given the growing burden, high medical need, and lack of effectiveness with current interventions, there is an urgent need for novel approaches to help prevent Lyme disease."

Subject to positive data from the VALOR study, Pfizer plans to submit a Biologics License Application to the FDA and a Marketing Authorization Application to the European Medicines Agency in 2026.

As summer vacations end and the fall outdoor season accelerates, the CDC advises everyone to be aware of tiny disease-carrying ticks that may appear where they are least expected.

Sub Title:

Lyme disease vaccine arrival expected in 2026

References:

US CDC Lyme disease map

Changes in the geographic distribution of the blacklegged tick, Ixodes scapularis, in the United States

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US CDC Lyme disease case map 2022

Lyme Disease Vaccine Candidate Approaches Approval

Karen McClorey Hackett — Wed, 17 Jul 2024 20:37:24 +0000

Reviewer:

Robert Carlson, MD

Lyme disease has been a nationally notifiable condition in the United States since 1991 without a U.S. Food and Drug Administration (FDA) approved vaccine.

Initially identified in Lyme, Connecticut, in 1976, over 63,000 cases of Lyme disease were reported by state health departments and the District of Columbia in 2022, primarily in the northeastern U.S.

However, based on the continued positive progress of an innovative multivalent protein subunit Lyme disease vaccine candidate, nature lovers may soon gain protection from this Black-legged tick-borne disease.

On July 17, 2024, Pfizer Inc. and Valneva SE announced that the participants of the Phase 3 clinical trial “Vaccine Against Lyme for Outdoor Recreationists” (VALOR) had completed the primary vaccination series (three doses) of VLA15.

These study participants will be monitored for the occurrence of Lyme disease cases until the end of the Lyme disease season in 2025.

Subject to positive data, VLA15 could be the first Lyme disease vaccine to become commercially available.

In 2026, Pfizer plans to submit a Biologics License Application to the FDA and a Marketing Authorization Application to the European Medicines Agency.

Juan Carlos Jaramillo, M.D., Chief Medical Officer, Valneva, commented in a press release, “We are pleased to see the progress of our Phase 3 VALOR trial. Lyme disease is the most prevalent vector-borne disease in the United States and Europe."

"It can result in debilitating complications and extensive healthcare treatments. Given the growing burden, high medical need, and lack of effectiveness with current interventions, there is an urgent need for novel approaches to help prevent Lyme disease.”

Pfizer and France-based Valneva entered into a collaboration agreement in April 2020 to co-develop VLA15, with updates to the terms within this agreement made in June 2022.

Sub Title:

VLA15 could be first approved protein subunit Lyme disease vaccine

References:

Valneva and Pfizer Announce Primary Vaccination Series Completion

CDC - Lyme Disease Surveillance and Data

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US CDC Lyme disease case map May 2024

Hexavalent Lyme Disease Vaccine Elicited Antibody Responses to OspA Serotypes

Karen McClorey Hackett — Mon, 03 Jun 2024 16:40:33 +0000

Reviewer:

Robert Carlson, MD

Lyme disease is recognized as the most common vector-borne illness in the Northern Hemisphere, but its actual incidence rate is unknown. It is estimated that over 400,000 people in the U.S. and 129,000 in Europe are diagnosed and treated for Lyme disease each year.

While the disease can be treated, many outdoor enthusiasts eagerly await a preventive vaccine's approval.

In February 2024, results from a survey indicated about 68% of parents in high- and emerging-incidence states would vaccinate their children against Lyme disease.

To address this pent-up consumer demand, the most advanced Lyme disease vaccine candidate announced encouraging news today.

On June 3, 2024, Valneva SE reported that the results of two Phase 2 clinical trials of Lyme disease vaccine candidate VLA15 were published in The Lancet Infectious Diseases. VLA15 is a hexavalent vaccine targeting the most prevalent Borrelia species (serotypes 1-6).

These trials and a third Phase 2 trial in pediatric participants supported the design of the current pivotal Phase 3 trial, VALOR.

The company says VLA15 has advanced the furthest of any Lyme vaccine candidates currently in clinical development.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, said in a press release, "We are pleased that these results are now fully available to the broader infectious disease community..... we are excited about the ongoing trials and progress towards potentially offering a vaccine against this unmet medical need."

The article, titled "Optimization of Dose Level and Vaccination Schedule for the VLA15 Lyme Borreliosis Vaccine Candidate Among Healthy Adults: Two Randomized, Phase 2 Studies" provides a detailed analysis of the VLA15-201 and VLA15-202 trial results, which investigated different dose levels and vaccination schedules of VLA15.

VLA15 was immunogenic across all dose groups and vaccination schedules tested.

The most potent antibody responses across all six serotypes were exhibited at the highest dose (180 µg) and broader vaccination intervals (Month 0,2,6). VLA15 has shown a favorable safety and tolerability profile across all trials to date.

Also, an independent Data Safety Monitoring Board observed no safety concerns in any treatment group.

The Phase 3 clinical trial, VALOR, is currently ongoing to investigate the efficacy, safety, and immunogenicity of VLA15 in participants five years of age and older in highly endemic regions in the United States, Canada, and Europe.

Unfortunately, VLA15 may not become available until 2026, when Valneva's development partner Pfizer aims to submit a Biologic License Application to the U.S. Food and Drug Administration and a Marketing Authorization Application to the European Medicines Agency.

The companies previously reported positive results for the booster phase of trial VLA15-202 and a third Phase 2 trial, VLA15-221, providing further evidence of VLA15's safety profile and its potential to provide immunity against Lyme disease in adult, pediatric, and adolescent populations.

Sub Title:

Valneva Lyme disease vaccine candidate VLA15 high dose multi month schedule associated with the greatest immune responses

Reference:

Lyme Disease Phase 2 Trials in the Lancet Infectious Diseases

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Potential On-Demand Lyme Disease Protection

Karen McClorey Hackett — Sun, 25 Feb 2024 13:14:39 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Tarsus Pharmaceuticals, Inc. has just announced positive topline results from the Phase 2a Carpo trial evaluating TP-05 (lotilaner). This novel, oral therapeutic candidate has shown remarkable effectiveness in preventing Lyme disease.

TP-05 is not U.S. FDA-approved but is believed to be the only non-vaccine, drug-based, preventative therapeutic in development designed to kill ticks before they transmit Lyme disease to people.

This vector-borne disease often goes undetected because ticks are not always noticed.

In most cases, ticks must be attached for about 36-48 hours or more before Lyme disease can be transmitted, so quickly killing ticks can significantly increase the probability of disease prevention.

“Lyme disease remains a growing public health concern associated with long-term consequences for millions of patients and an estimated $1 billion dollar price tag for the U.S. healthcare system,” said Bobby Azamian, M.D., Ph.D., Chief Executive Officer and Chairman of Tarsus, in a press release on February 22, 2024.

“We are highly encouraged by these early proof-of-concept data and the opportunity to bring forward a novel, on-demand, oral treatment that addresses the root cause of disease – the ticks that transmit the bacteria that cause Lyme disease.”

TP-05 is an oral systemic formulation of lotilaner, a well-characterized anti-parasitic agent that selectively inhibits parasite-specific GABA-Cl channels. Both the high and low doses of TP-05 demonstrated a statistically significant benefit in killing ticks compared to placebo.

Specifically, after the Day 1 tick challenge, mean tick mortality was 97.0% (± 1.4 standard error, SE) and 92.0% (± 6.3 SE) for the high and low doses of TP-05, respectively, compared to only 5.0% (± 2.5 SE) for placebo (p < 0.0001).

Similarly, at the 30-day challenge, mean tick mortality 24 hours after placement was 89.0% (± 11.1 SE) and 91.0% (± 6.1 SE) for the high and low doses of TP-05, respectively, compared to only 9.0% (± 8.0 SE) for placebo (p<0.001).

No statistically significant differences in tick mortality were observed between the two TP-05 treatment arms, and TP-05 was generally well tolerated.

Linden Hu, M.D., the Paul and Elaine Chervinsky Professor in Immunology at Tufts University School of Medicine and Principal Investigator for the Carpo trial, commented: “The tick-kill rates seen at Day 1 and Day 30 suggest that TP-05 may have the potential to provide both rapid and durable protection against multiple tick-borne diseases, which would be a welcome alternative to vaccines in the prevention armamentarium.”

Lyme disease can potentially cause severe, often debilitating symptoms with permanent and irreversible damage.

The disease can result in inflammation, nerve, joint, and muscle pain and swelling, numbness, shortness of breath, and – in severe cases – neurological complications such as facial palsy, vision issues, and meningitis, including severe headaches and neck stiffness, as well as cardiac complications.

Data from the U.S. Centers for Disease Control and Prevention shows Lyme disease outbreaks increased by 69% during 2017–2019 in the United States. And the risk of Lyme disease spreading to new geographical areas.

As of 2022, high-incidence jurisdictions are Connecticut, Delaware, the District of Columbia, Maine, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, West Virginia, and Wisconsin.

As of February 2024, there are no FDA-approved pharmacological prophylactic options for Lyme disease.

However, an innovative Lyme disease vaccine candidate is conducting late-stage clinical research in 2024. VLA15 is a multivalent recombinant protein vaccine that protects humans by increasing antibodies that prevent Borrelia from migrating from ticks after a bite.

Pfizer recently indicated it could submit a Biologics License Application for VLA15 to the U.S. FDA as early as 2025.

Sub Title:

TP-05 demonstrated tolerability and statistically significant tick mortality

References:

Positive Topline Results from a Phase 2a Proof-of-Concept “Tick-Kill” Trial

Surveillance for Lyme Disease After Implementation of a Revised Case Definition

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US CDC Interim 2022 data as of February 13, 2024

First Lyme Disease Vaccine Licensed for Mice

Karen McClorey Hackett — Wed, 10 May 2023 07:32:21 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The U.S. Department of Agriculture recently issued a Conditional Licensure for a novel oral vaccine against the wildlife spread of Borrelia burgdorferi, the bacterium responsible for Lyme disease.

Announced by US Biologic, Inc. on May 9, 2023, this innovative Borrelia Burgdorferi Bacterin vaccine is spray-coated onto pellets that mice consume.

As the expression goes, if you give a mouse a vaccine..... good things happen!

The only known vector of Lyme disease is blacklegged ticks, which are infected primarily by feeding on mammals, particularly white-footed mice.

If infected with Borrelia burgdorferi, these ticks feed on humans causing Lyme disease.

US Biologic offers this Lyme disease vaccine in residential settings, pest management professionals, public lands such as parks and commercial areas, and recreational facilities, including golf courses.

Furthermore, the Company is working with federal and state health agencies that service the areas most at risk for infection.

Chris Przybyszewski, the Company's President, and Board Secretary, informed Precision Vaccinations, "Three out of four emerging infectious diseases come from animals. As such, any serious approach to public health must include those animals involved in disease transmission."

"At the same time, we must go where the animals live (e.g., backyards). We must marshal existing workforces, such as pest-management professionals, who can find an attractive business model in controlling disease transmission in reservoirs and vectors."

"Considering pest-management professionals as "public health professionals" is a paradigm change from a consumer perspective."

"But it makes sense if bringing the consumer an understanding of the mechanisms of infection control."

The Company's proprietary OrisBio oral-delivery platform is changing global disease prevention, empowering the safe, effective, and cost-efficient delivery of vaccines and therapeutics.

Each animal species is different, as are its feeding habits, its environments, and its microbiome. Understanding an animal's digestive tract is essential in delivering vaccines to the right place in the animal's intestines.

Field trials demonstrating real-world impact have been conducted and co-published by the Cary Institute of Ecosystem Studies, the U.S. CDC, the Connecticut Agricultural Experiment Station, the University of Pennsylvania, the University of Tennessee Health Science Center, Yale University, and others.

Lyme disease is caused by Borrelia burgdorferi spirochetes, transmitted to humans by certain Ixodes spp. ticks says the CDC. Most persons recover fully, especially those who receive early and appropriate treatment.

However, Lyme disease infections can become a multi-year health concern.

The frequency of Lyme disease is often misunderstood as substantial underreporting occurs.

Note: Lyme disease vaccines for humans remain in late-stage clinical trials.

Sub Title:

Novel oral Lyme disease vaccine reduces wildlife spread of Borrelia burgdorferi

References:

USDA Approves Novel Vaccine Against Wildlife Spread of the Bacterium Responsible for Lyme Disease

CDC: Volume 27, Number 2—February 2021 Dispatch Estimating the Frequency of Lyme Disease Diagnoses

USDA

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While Awaiting Lyme Disease Vax, Treatment Reduction Offers Benefits

Donald Hackett — Mon, 10 Oct 2022 16:39:21 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

Next-generation Lyme Disease treatments and vaccines continue to be in high demand in Europe and the U.S. As the geographic footprint of this vector-borne illness widens, it is estimated that 476,000 people in the U.S. and 130,000 people in Europe are impacted each year.

Recent news announced by New York-based Pfizer Inc. and France-based Valneva SE confirmed their investigational Lyme disease vaccine candidate VLA15 is progressing with a late-stage clinical trial.

Pending successful completion of the Phase 3 study, Pfizer could potentially submit a Biologics License Application to the U.S. Food and Drug Administration (FDA) and Marketing Authorisation Application to the European Medicines Agency in 2025.

Until then, treating Lyme disease infections remains a top priority.

Researchers from Solvaneia recently reported in The Lancet Infectious Diseases how to reduce potentially harmful antibiotic overuse by identifying shorter effective treatments.

This clinical study aimed to assess whether oral doxycycline for seven days was non-inferior to 14 days of treatment in adults with solitary erythema migrans.

In this randomized open-label non-inferiority trial, they enrolled about 300 patients with solitary erythema who were given doxycycline 100 MG Oral Tablet at the University Medical Centre in Ljubljana, Slovenia.

Five of 147 patients from the 7-day group versus 3 of 147 patients from the 14-day group had treatment failure manifesting as persistence of erythema (difference 1.4%; upper limit of one-sided 95% CI 5.2%; p=0·64).

This study's data supports the reduced seven days of treatment with oral doxycycline for patients with solitary erythema migrans.

The benefit of this finding is reducing antibiotic exposure to the current guideline-driven therapy.

The researchers wrote, "The 7-day regimen appears to fulfill the fundamental treatment goals of preventing progression to more advanced Lyme disease while limiting antibiotic exposure."

The U.S. CDC says Lyme disease is generally caused by the bacterium Borrelia burgdorferi.

Left untreated, the disease can disseminate and cause more serious complications affecting the joints, the heart, or the nervous system.

Lyme disease is transmitted to humans through the bite of infected black-legged ticks.

Until a Lyme disease vaccine is approved, the steps to prevent Lyme disease include using insect repellent, removing ticks promptly, applying pesticides, and reducing tick habitat.

A recent study by FAIR Health found a significant increase in Lyme disease diagnoses over the past 15 years in the U.S.

Results of the study published on August 5, 2022, indicate that from 2007 to 2021, private insurance claim lines with Lyme disease diagnoses increased by 357% in rural areas and 65% in urban areas.

In 2021, the top U.S. states were New Jersey, Vermont, Maine, Rhode Island, and Connecticut.

As of October 10, 2022, the FDA had not approved any Lyme disease vaccine.

PrecisionVaccinations publishes fact-checked, research-based vaccine news manually translated and curated for mobile readership.

Sub Title:

Lyme disease vaccine candidate continues phase 3 clinical trial

References:

Treatment of erythema migrans with doxycycline

Study by University of Ljubljana School of Medicine, Slovenia

Lyme Disease Vaccine (VLA15)

CDC Lyme disease

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2022 FAIR Health Lyme Disease

Who is Infected With Tick-borne Lyme Disease

Don Hackett — Tue, 14 Jun 2022 17:38:49 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

Lyme disease has continued to spread worldwide, but there’s little scientific agreement on how common is this tick-borne disease.

To resolve this knowledge gap, the open-access journal BMJ Global Health revealed a pooled data analysis on June 13, 2022, that found more than 14% of the world’s population probably has or has had the presence of antibodies to Borrelia burgdorferi sensu lato (Bb) infection in the blood.

The three regions with the highest reported seroprevalence were Central Europe (21%), Eastern Asia (16%), and Western Europe (13.5%).

At the other end of the scale, the regions with the lowest reported seroprevalence were the Caribbean (2%), Southern Asia (3%), and Oceania (nearly 5.5%).

A smaller pooled analysis of the results of 58 different studies showed that older age (50+), men, residence in a rural area, and being bitten by a tick were all associated with a heightened risk of Bb antibodies.

“Our results indicate that the prevalence of Bb in 2010–2021 was higher than that in 2001–2010,” wrote the study’s authors.

However, the study authors conclude: “The reported estimated global Bb seropositivity is relatively high….[Lyme disease] is a widely distributed infectious disease but has not received much attention worldwide.”

“A more accurate picture of its global distribution and who is most at risk of infection could inform the development of public health response policies and [Lyme disease] control programs,” they suggest.

The U.S. CDC says, ‘There is no way of knowing exactly how many people get Lyme disease.’

A recently released estimate based on insurance records suggests that each year approximately 476,000 Americans are diagnosed and treated for Lyme disease. Regardless, this number indicates a significant burden on the healthcare system and the need for more effective prevention measures.

While the U.S. FDA has not approved a Lyme disease preventive vaccine, one candidate is conducting a late-stage, phase 3 clinical study.

France-based Valneva SE vaccine candidate VLA15 is a multivalent recombinant protein vaccine targeting the outer surface protein A of Borrelia, aiming for protection against most human pathogenic Borrelia species.

Valneva and New York-based Pfizer, Inc. announced a collaboration for VLA15's development and commercialization in April 2020.

On February 4, 2022, Valneva and Pfizer announced a three-dose primary series vaccination schedule in a planned Phase 3 clinical trial with adults and pediatric subjects and is expected to be initiated in the third quarter of 2022, subject to regulatory approval.

Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer, commented in a press release issued on April 26, 2022, “The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.”

“These positive pediatric data mark an important step forward in the ongoing development of VLA15, and we are excited to continue working with Valneva to potentially help protect both adults and children from Lyme disease.”

Note: No researcher industry conflicts of interest were disclosed. Dong Y, Zhou G, Cao W, et al. Global seroprevalence and sociodemographic characteristics of Borrelia burgdorferi sensu lato in human populations: a systematic review and meta-analysis BMJ Global Health 2022;7:e007744.

Professor Fukai Bao; baofukai@kmmu.edu.cn.

PrecisionVaccinations publishes fact-checked, research-based vaccine news that is curated for mobile readership.

Sub Title:

Lyme disease global seroprevalence found in Europe and Asia

References:

Global seroprevalence and sociodemographic characteristics of Borrelia burgdorferi sensu lato in human populations: a systematic

CDC: Lyme Disease

Valneva and Pfizer Report Positive Phase 2 Pediatric Data for Lyme Disease Vaccine Candidate

Lyme Disease Vaccine (VLA15)

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by CDC

Lyme Disease Testing May Depend on Autoantibody Biomarkers

Karen McClorey Hackett — Thu, 17 Mar 2022 17:11:25 +0000

Reviewer:

Robert Carlson, MD

Researchers at Massachusetts-based Tufts University School of Medicine recently announced they identified a testing mechanism that detects a type of antibody, infected individuals produce, against a substance the Lyme bacteria acquires from the host to grow.

These researchers stated on March 15, 2022, they believe tests to detect auto-antibodies, which are antibodies that mistakenly target and react with a person's tissues or organs, could empower clinicians with a way to diagnose Lyme disease sooner.

And to know whether treatment with treatment antibiotics is working and identify which patients have been reinfected.

Authors of the study, published by the Journal of Clinical Investigation, are Peter Gwynne, Luke Clendenen, and Linden Hu of the school’s Department of Molecular Biology and Microbiology, and colleagues at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health.

Testing to detect Lyme disease exists, but it has limitations, says Gwynne, the study's lead author and research scientist at Tufts School of Medicine.

“Traditional Lyme tests can stay positive for prolonged periods after treatment – years or even a lifetime,” he commented in a related press release.

“As a result, for some individuals suffering from symptoms that resemble long-term Lyme disease infection, clinicians are never sure whether the patient has persistent Lyme disease, was cured and then reinfected, or was cured and is suffering from something else.”

“We started this current work to learn how Borrelia burgdorferi acquires key nutrients, like fats, for growth,” says Gwynne.

“The Lyme bacteria, despite being a very successful pathogen, is much more dependent than other bacteria on acquiring nutrients from its environment.”

“In our research, we found that the organism takes fats called phospholipids directly from its surroundings in the host and puts them on its surface,” added Hu, the Vice Dean of Research at the school and Paul and Elaine Chervinsky Professor of Immunology.

“That finding led us to see if the bacteria's direct use of a host fat might lead the immune system to recognize it as a foreign substance and create antibodies to it.”

The scientists discovered that both animals and patients infected with the Lyme bacterium developed autoantibodies to multiple phospholipids.

Because autoantibodies can damage the host, these autoantibodies are tightly regulated and tend to disappear quickly once the stimulating factor is removed.

“The antibodies also seem to develop much more quickly than traditional antibodies to the Lyme bacteria, likely because your body has previously created these autoantibodies and downregulated them,” says Hu.

While current testing makes it difficult to diagnose reinfection or successful treatment, “the antiphospholipid autoantibodies—because of their quick increase and quick resolution with treatment—can fill these gaps as a novel additional test,” Gwynne says.

“They may make it possible to tell whether a treatment has eradicated the Lyme disease bacteria. And they therefore also make it possible to tell if a patient with a prior infection now has a new infection.”

Gwynne and Hu have a provisional patent pending describing the use of antiphospholipid antibodies in diagnosing Lyme disease. They hope that if their discovery is borne out by further research, a diagnostic company could begin the development of a commercially available version of their test within a couple of years.

Lyme disease was identified five decades ago along the Connecticut coast and spread across New England and the mid-Atlantic region, affecting almost 500,000 people in the U.S. every year.

Caused by a bite from an infected tick, it frequently goes undetected unless a person notices the telltale rash that forms around the bite.

Lyme disease can lead to debilitating long-term complications, including arthritis, fatigue, mental impairment, and attacks on the heart and brain tissue in the most severe cases.

Caused by the bacterium Borrelia burgdorferi, Lyme disease can often be treated with antibiotics.

An important question, which was not examined in the current paper, is whether these autoantibodies may identify a subset of patients who will develop persistent Lyme disease symptoms after treatment.

Up to 20% of patients can develop persistent symptoms after Lyme disease. Diagnosis of these patients is currently only by clinical symptoms, making it likely that patients with different causes of their symptoms are grouped together.

And treatment trials in patients with persistent Lyme disease are unlikely to benefit if that occurs.

“Antiphospholipid antibodies are commonly seen in autoimmune diseases like lupus and are associated with blood clots and persistent inflammation that causes other disease conditions,” says Hu.

“Many of the persistent symptoms in patients who continue to have symptoms after being diagnosed with Lyme disease are similar to those autoimmune diseases.”

“If there ends up being a link between having persistent Lyme symptoms and these autoantibodies, this would be the first test that could be used to distinguish a group of patients who have persistent Lyme disease,” he says.

“It would allow us to test specific new therapies targeted to a defined mechanism.”

Currently, the U.S. FDA has not approved a Lyme disease vaccine. However, there are Lyme disease vaccine candidates in late-stage studies.

An example is Valneva SE’s Lyme Disease vaccine candidate VLA15, a multivalent recombinant protein vaccine targeting the outer surface protein A of Borrelia.

Valneva and its development partner Pfizer Inc. announced on February 4, 2022, a three-dose primary series vaccination schedule in a planned Phase 3 clinical trial is expected to be initiated in 2022, subject to regulatory approval.

PrecisionVaccinations publishes fact-checked research-based vaccine news.

Note: The press release and study results were edited for clarity and curated for mobile readers.

Sub Title:

Lyme disease vaccine availability is pending FDA approval

References:

A Potential New Test for Diagnosing Lyme Disease

Antiphospholipid autoantibodies in Lyme disease arise after scavenging of host phospholipids by Borrelia burgdorferi

Lyme Disease Vaccine (VLA15)

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Pediatric Lyme Disease Vaccine Study Launched

Don Hackett — Wed, 02 Dec 2020 18:28:07 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

A France-based specialty vaccine company announced its plans to accelerate pediatric development of the Lyme vaccine candidate, VLA15, in collaboration with Pfizer Inc.

Valneva SE stated in a press release the planned initiation of the study VLA15-221 would be in the first quarter of 2021, subject to regulatory approval.

If approved, it will be the first clinical study to enroll a pediatric population aged 5-17 years and compare the 3-dose vaccination schedule on month 0-2-6, with a reduced 2-dose schedule of month 0-6.

“This will be an important study that we anticipate will provide evidence that the vaccine can be used in the populations that are at risk of the devastating consequences of Lyme disease, using a simplified schedule,” stated Kathrin Jansen, Senior Vice President and Head of Pfizer Vaccine Research and Development.

VLA15-221 is planned as a randomized, observer-blind, placebo-controlled Phase 2 study. The study will currently include approximately 600 healthy participants (5-65 years of age) who will receive VLA15 at the dose of 180µg, which was selected based on recent data generated in the two ongoing Phase 2 studies.

VLA15-221 will also investigate a booster dose of VLA15, administered one year following the 6 Month dose.

This study will complement the ongoing Phase 2 studies VLA15-201 (July 2020) and VLA15-202 (October 2020).

All three Phase 2 trials are anticipated to support a Phase 3 pivotal efficacy trial, including all Lyme vaccine candidates' main target populations starting in 2022.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, commented, “We believe that including the pediatric population early on could provide support for the Phase 3 study to include all major target groups for our future Lyme vaccine candidate and may potentially support successful market access including respective recommendations.”

Valneva and Pfizer entered into a collaboration agreement in April 2020 to co-develop and commercialize VLA15.

VLA15 is the only active Lyme disease vaccine in clinical development today and covers six serotypes prevalent in North America and Europe. This investigational multivalent protein subunit vaccine targets the outer surface protein A (OspA) of Borrelia, an established action mechanism for a Lyme disease vaccine.

OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick. VLA15 has demonstrated promising immunogenicity and safety data in pre-clinical and clinical studies so far.

VLA15 will be tested as an alum-adjuvanted formulation and administered intramuscularly. The study will be conducted at sites located in areas where Lyme disease is endemic and will enroll volunteers with clear past infection with Borrelia burgdorferi, the bacteria that cause Lyme disease, and B. burgdorferi naïve volunteers, says the company.

Lyme disease is a systemic infection caused by Borrelia bacteria burgdorferi sensu lato transmitted to humans by infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere.

According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 300,000 Americans are diagnosed with Lyme disease each year, with at least an additional 200,000 cases in Europe.

Early symptoms of Lyme disease are often overlooked or misinterpreted. Left untreated, the disease can disseminate and cause more serious complications affecting the joints (arthritis), the heart (carditis), or the nervous system.

For more information, visit Valneva.

PrecisionVaccinations publishes research-based vaccine development news.

Sub Title:

Valneva VLA15 vaccine candidate covers 6 serotypes that are prevalent in North America and Europe

References:

Valneva Announces Acceleration of Pediatric Development for Lyme Disease Vaccine Candidate

VLA15 Lyme Disease Vaccine

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France’s Lyme Disease Vaccine Candidate Continues Posting Positive Results

Don Hackett — Tue, 20 Oct 2020 21:42:39 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

A France based specialty vaccine company announced positive initial results for its second Phase 2 study (VLA15-202) of Lyme disease vaccine candidate VLA15.

VLA15 is the only active Lyme disease vaccine in clinical development, and covers (6) serotypes that are prevalent in North America and Europe.

Valneva SE’s Juan Carlos Jaramillo, M.D., Chief Medical Officer, stated in a press release published on October 20, 2020, “We are extremely pleased with these results which showed an excellent immunological profile, further supported by additional positive data through the Serum Bactericidal Assay (SBA).”

“With these encouraging data, we are now well-positioned to continue vaccine development. Lyme disease continues to be a high unmet medical need and our objective remains to work closely with Pfizer to offer a preventative solution as soon as possible.”

Compared to study VLA15-201, study VLA15-202 investigated a vaccination schedule of Month 0-2-6 based on matching doses. And, VLA15 was generally safe across all doses and age groups tested.

The VLA15 vaccine candidate’s tolerability profile including fever rates was comparable to other lipidated recombinant vaccines or lipid-containing formulations.

Furthermore, as in VLA15-201, no related Serious Adverse Events (SAEs) were observed in any treatment group. Reactogenicity decreased following the first vaccination.

Compared to study VLA15-201, immunogenicity was further enhanced using a Month 0-2-6 schedule. The Seroconversion Rates (SCR), after completion of the primary vaccination series, showed similar responses and ranged from 93.8% [ST1] to 98.8% [ST2, ST4]. Antibody responses were comparable in the 2-dose groups tested.

The immunological response in older adults, one of the main target groups for a Lyme vaccine, is particularly encouraging, as already observed in VLA15-201.

Moreover, these new results did not indicate that prior exposure to Borrelia spirochetes (seropositivity) has an impact on immunogenicity or safety, also as observed in VLA15-201.

An SBA assessing the functional immune response against Lyme disease after vaccination with VLA15 was conducted for the first time and demonstrated the functionality of antibodies against all OspA serotypes.

Assays, such as SBAs, are commonly used to enable a potential prediction of vaccine efficacy via the measurement of vaccine-induced functional immune responses.

This investigational multivalent protein subunit vaccine VLA15 targets the outer surface protein A of Borrelia, an established mechanism of action for a Lyme disease vaccine. OspA is one of the most dominant surface proteins expressed by the bacteria when present in a tick.

Lyme disease Overview

Lyme disease is a systemic infection caused by Borrelia bacteria transmitted to humans by infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere.

According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 300,000 Americans are diagnosed with Lyme disease each year with the state of Pennsylvania reporting the most cases in 2018.

And, at least a further 200,000 cases were confirmed in Europe.

The number of counties with an incidence of ≥10 confirmed cases per 100,000 persons increased from 324 in 2008 to 415 in 2018, says the CDC.

Early symptoms of Lyme disease include a gradually expanding erythematous rash called Erythema migrans or more unspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia, or myalgia, are often overlooked or misinterpreted.

Left untreated, the disease can disseminate and cause more serious complications affecting the joints, the heart, or the nervous system.

For more information, visit Valneva.

PrecisionVaccinations publishes research-based vaccine development news.

Sub Title:

Valneva VLA15 Lyme disease vaccine candidate is designed to confer protection by raising antibodies that prevent Borrelia from migrating from ticks to humans after a bite

References:

Valneva Announces Positive Initial Results for Second Phase 2 Study of Lyme Disease Vaccine Candidate VLA15

CDC: Lyme Disease Recent Surveillance Data

VLA15 Lyme Disease Vaccine

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Thursday, September 2, 2021 - 08:00

Antibody-Specific Lyme Disease Tests Announced

Don Hackett — Mon, 05 Oct 2020 14:27:04 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

Two new Lyme IgG and Lyme IgM EIA kits for detection of antibodies against Lyme disease-causing bacteria were announced today.

The separate IgG and IgM assays provide laboratories the ability to offer more specificity in their Lyme screen algorithm.

The two assays give laboratories a more diverse arsenal of testing methodologies that enables them to achieve more reliable Lyme disease test results, stated California based Gold Standard Diagnostics Group (GSD).

They are designed for optimal functionality in diagnostic laboratories with a total incubation time of 45 minutes at room temperature with ready-to-use controls. The kits can be run manually or on any open automated EIA platform.

Furthermore, the GSD Lyme IgG and Lyme IgM EIA assays were made to provide antibody specific reliable information to the clinicians diagnosing this disease, said the company.

As of October 5, 2020, these assays are available in the USA.

This is important news since ‘untreated Lyme disease can produce a wide range of symptoms, depending on the stage of infection’ says the US Centers for Disease Control and Prevention (CDC). Lyme disease is the most commonly occurring vector-borne disease and the 6th most commonly reported notifiable infectious disease in the USA.

“We are witness to major changes in Lyme diagnostics. Our team of professionals is adapting and responding to these changes,” states Dr. Barry Menefee, Infectious Disease Specialist at GSD.

Experts have recently found, Americans infected with Lyme disease is 10x higher than what is reported by the CDC.

A new study tracked the diagnostic testing of 5.2 million people throughout the USA and found that as many as 300,000 Americans contract Lyme disease each year.

This data substantially differs from 33,666 confirmed and probable cases of Lyme disease reported to the CDC in 2018, which was about 21 percent fewer cases than in 2017.

This under-diagnosing issue is related to Lyme disease symptom variability that it is often quite challenging to diagnose and can range from fever and headaches to irregular heartbeats, dizziness, and nerve pain.

The CDC says ‘Lyme disease patients treated with appropriate antibiotics in the early stages of Lyme disease usually recover rapidly and completely. Antibiotics commonly used for oral treatment include doxycycline, amoxicillin, or cefuroxime axetil.’

A specialty vaccine company based in France announced positive initial results for its first Phase 2 study of Lyme disease vaccine candidate VLA15.

In a press statement published on July 22, 2020, Valneva SE stated the VLA15 vaccine candidate was found immunogenic across all dose groups tested. And the VLA15-201 study’s results did not indicate that prior exposure to Lyme (seropositivity) has an impact on immunogenicity or safety.

VLA15 is an investigational multivalent protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia.

PrecisionVaccinations publishes Lyme disease vaccine and therapeutic news.

Sub Title:

Gold Standard Diagnostics Lyme IgG and Lyme IgM EIA kits deliver antibody specific reliable data

References:

Gold Standard Diagnostics Receives FDA 510K for Lyme IgG and IgM EIA Kits

CDC: Lyme Disease

VLA15 Lyme Disease Vaccine

Lyme Disease Cases Significantly Under-Counted

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