Lyme Disease

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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Pennsylvania's Lyme Disease Season Approaching Again

Karen McClorey Hackett — Thu, 27 Mar 2025 22:38:22 +0000

Reviewer:

Robert Carlson, MD

Since Lyme disease became a nationally notifiable condition in 1991, the northeastern section of the United States has borne the bulk of cases. With freezing temperatures fading and snow melting away, the risk of Lyme disease is returning to the northeastern section of the United States.

While ticks can be found in various environments, such as in tall grasses, mountain ranges, and even your yard, it is essential to take preventive measures to avoid tick bites, especially in Pennsylvania.

Of the 89,000 Lyme disease cases reported in 2023, Pennsylvania reported 8,431, the second-most in the U.S.

All 67 counties in Pennsylvania reported Lyme disease cases in 2023, ranging from 8 in Sullivan County to 601 in Chester County, located just west of Philadelphia.

According to data from the Pennsylvania Department of Health Tickborne Diseases Dashboard, the Lyme disease season generally starts in April, and cases are reported for the next few months.

About 54% of cases were reported between May and August in 2022.

In a state like Pennsylvania, Lyme disease can often be diagnosed based solely on the appearance of an erythema migrans rash. If no rash is present or it doesn't look typical, a blood test can be used for diagnosis.

The blood sample is sent to a lab for a screening test, which checks for antibodies to Lyme disease. The first test is usually an ELISA, and the second is often a Western Blot, although both can also be types of ELISA tests.

These Lyme disease tests are offered at commercial labs in the U.S.

Ixodes scapularis is a primary vector for tickborne pathogens in North America. Repeated exposure to these ticks can trigger a humoral immune response to tick antigens, leading to acquired tick resistance.

However, identifying the specific antigens contributing to this resistance is challenging due to the many proteins secreted by I. scapularis during feeding.

To tackle this issue, researchers recently developed a technique called I. scapularis Rapid Extracellular Antigen Monitoring, which can detect antibody responses to over 3,000 tick antigens.

Additionally, they studied the natural immune response to tick bites by profiling the antigens recognized by IgG from a tick-resistant individual, others who had Lyme disease, and tick-bitten guinea pigs and mice.

In total, they identified 199 recognized antigens. Notably, several of these antigens contained histamine-binding domains.

From a prevention perspective, the U.S. Food and Drug Administration and the European Medicines Agency have not approved a preventive Lyme disease vaccine in 2025. The only human Lyme disease vaccine marketed in the U.S. was discontinued in 2002.

One multivalent Lyme disease vaccine candidate co-produced by Pfizer Inc. and Valneva SE targets Borrelia's outer surface protein A. The VLA15 vaccine candidate is conducting late-stage clinical trials in 2025 and is accepting new participants.

Until a Lyme disease vaccine becomes available in the U.S., states such as Pennsylvania suggest paying close attention to the little bugs hiding along your walk in the woods.

Sub Title:

Valneva and Pfizer Lyme disease vaccine candidate currently underway

References:

Penn Dept of Health 2025

Tick feeding or vaccination with tick antigens elicits immunity to the Ixodes scapularis exoproteome in guinea pigs and humans

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Penn Dept of Health - Lyme Disease Cases

Some Lyme Disease Treatments Lack Value

Karen McClorey Hackett — Thu, 06 Feb 2025 10:22:55 +0000

Reviewer:

Robert Carlson, MD

While the world awaits the approval of a Lyme disease vaccine, many patients have sought out treatment that may lack measurable value. Lyme disease has been nationally notifiable in the United States since 1991, significantly impacting thousands of hikers and nature lovers annually.

The Open Forum Infectious Diseases published a report on January 15, 2025, that many non-traditional clinics for chronic Lyme disease exist in states where the disease is endemic, and the treatments offered at such clinics are often unproven and costly and raise safety concerns.

For this study, University of Minnesota investigators analyzed treatments offered at standalone clinics in 14 states with high Lyme disease prevalence. They analyzed 117 US clinics that provide conventional, complementary, and alternative medicine approaches to Lyme disease care.

Herbs and supplements were the most common treatment offered by the clinics (45%), followed by non-antibiotic intravenous therapy (26%), unspecified antibiotics (22%), hyperbaric oxygen therapy (15%), and ozone-based therapy (13%).

The cost of care was variable and can be high, suggesting that patients with limited health insurance coverage may have significant out-of-pocket expenditures. For example, the costs for an initial consultation ranged from $87 to $3,250.

Hyperbaric oxygen therapy was the most expensive treatment ($85 to $6,400).

The study authors wrote, 'Some therapies we found also expose patients to unnecessary risks. For example, non-evidenced-based antibiotic regimens—particularly those that are prolonged or administered intravenously via a central venous catheter—have been associated with life-threatening complications, including fatal cases of catheter-associated bloodstream infections and Clostridioides difficile infection.'

Major autohemotherapy, an unproven therapy, may also increase a patient's bloodstream infections.

Although limited to a minority of clinics, this study found that some clinics offer "hyperthermia protocols" and intravenous hydrogen peroxide" raises safety concerns.

According to the U.S. CDC, people treated with appropriate antibiotics in the early stages of Lyme disease usually recover rapidly and completely. The antibiotics most commonly used to treat Lyme disease include doxycycline, amoxicillin, or cefuroxime axetil.

The CDC generally does not recommend antibiotics after tick bites to prevent tickborne tickborne.

However, in certain circumstances, a single dose of doxycycline after a tick bite in an area where Lyme disease is common may lower the risk of Lyme disease.

As of February 6, 2025, one innovative Lyme disease vaccine candidate (VLA15) is advancing in late-stage clinical research.

Note: The authors did not declare any industry conflicts of interest.

Sub Title:

Lyme disease vaccine approval pending

Reference:

Characteristics of clinics offering non-traditional Lyme disease therapies

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50% of Northeastern Adult Ticks Carry Lyme Disease

Karen McClorey Hackett — Mon, 27 Jan 2025 18:50:02 +0000

Reviewer:

Robert Carlson, MD

As the snow melts away in the Northeast, hikers will return to the hills in the spring of 2025, and so will an unwanted tick that carries a severe disease.

Researchers from Dartmouth College recently reported that many states in the Northeast—including Connecticut, New York, New Hampshire, Vermont, and Maine — are at risk for contracting Lyme disease during the spring, summer, and fall.

A new meta-analysis of data collected from 1989 to 2021, led by the Dartmouth study and published in the journal Parasites & Vectors, reveals that 50% of adult blacklegged (Ixodes scapularis) ticks carry the bacteria that causes Lyme disease.

In comparison, up to 25% of younger (nymph) blacklegged ticks also carry the bacteria.

For 2017–2021, the statewide average prevalence of B. burgdorferi ranged from 19% to 25% in I. scapularis nymphs and from 49% to 54% in I. scapularis adults. The statewide average prevalence of all other pathogens in I. scapularis for 2017–2021, including A. phagocytophilum (4–6% for nymphs, 4–9% for adults), B. microti (4–8% for nymphs, 2–13% for adults) and B. miyamotoi (1–2% for nymphs, 1–2% for adults), was considerably less.

“While the bacteria responsible for Lyme disease has a complicated chain of transmission, our results show the relative abundance of blacklegged ticks, and just how many of them are carrying disease-causing pathogens throughout the Northeast,” stated lead author Lucas Price in a press release on January 16, 2025, who was a postdoctoral fellow in geography at Dartmouth at the time of the study.

In 2025, Lyme disease ticks have progressed westward into many midwestern states, which have reported significant increases. However, tick abundance has not changed along the more southern latitudes in the United States.

Various data sources reported about 63,000 Lyme disease cases in 2022, 1.7 times the annual average of 37,000 cases. However, health experts say this data does not account for the actual incidence of Lyme disease.

In the United Kingdom, the Health Security Agency says that approximately 4% of ticks in England and Wales are infected with Lyme disease.

These findings underscore advice from the U.S. CDC that recommends a range of tick bite prevention measures, including conducting full-body tick checks after spending time outdoors.

From a protection perspective, a Lyme disease vaccine candidate is conducting late-stage research with hopeful expectations of positive news in 2026.

Sub Title:

Lyme disease vaccine candidates is conducting clinical research in 2025

References:

Spatial and temporal distribution of Ixodes scapularis and tick-borne pathogens across the northeastern U.S.

Study maps tick abundance and Lyme disease bacteria prevalence over 30 years.

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Parasites & Vectors Nov. 2024

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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Front. Cell. Infect. Microbiol., 17 November 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

Lyme Disease Vaccine Candidate Leverages mRNA Technology

Karen McClorey Hackett — Wed, 20 Sep 2023 20:04:06 +0000

Reviewer:

Robert Carlson, MD

New preclinical research from the Perelman School of Medicine at the University of Pennsylvania suggests that an innovative vaccine candidate can prevent developing Lyme disease in people.

While there are existing Lyme disease vaccines for dogs, no vaccine candidate is approved for people.

“Bacteria are more complex organisms than viruses, and therefore, it can be more challenging to develop effective vaccines against them,” said senior author Norbert Pardi, Ph.D., an assistant professor of Microbiology, in a press release on September 19, 2023.

“Here we were able to identify a target for a mRNA vaccine that shows promising results for preventing B. burgdorferi infection in animal models.”

The vaccine, described in an Original Article published in the journal Cell Press on August 1, 2023, uses the same messenger ribonucleic acid (mRNA) technology pioneered at Penn.

They identified one of the proteins in B. burgdorferi that elicits a potent immune response called outer surface protein A (OspA).

OspA is a conserved protein in the multiple strains of B. burgdorferi, making it an ideal target for preventing an initial B. burgdorferi infection from progressing to Lyme disease.

These Penn researchers demonstrated that OspA mRNA-lipid nanoparticle (LNP) displayed superior immunogenicity and efficacy to an alum-adjuvanted OspA protein subunit vaccine when used at 3 μg and 1 μg dose, respectively.

First, mice immunized with a single dose of OspA mRNA-LNP elicited more robust polyfunctional CD8+ and CD4+ T cell responses than the OspA protein vaccine.

Though antibody response is the key to preventing B. burgdorferi infection in the host, anti-OspA CD8+ T cells could provide further immune support as spirochetes in some patients express OspA in late infection.

Second, one particular subset of CD4+ T cells, Tfh cell, and with antigen-specific GC B cells, were more greatly elevated in mice after a single vaccination with OspA mRNA-LNP than in mice immunized with rOspA + alum.

Increased magnitude of germinal center responses corresponded to increased levels of its terminal outputs, antigen-specific,c MBCs and LLPCs, which secreted IgG1, IgG2a, andIgG2b, after immunization with a single dose of OspA mRNA-LNP.

Third, a prime-boost regimen of OspA mRNA-LNP compared to one of rOspA + alum yielded higher, longer-lasting levels of OspA-specific antibodies, which are crucial to blocking the transmission of B. burgdorferi to the host from feeding ticks.

Most importantly, a single dose of OspA mRNA-Lly protected mice from B. burgdorferi infection successfully than its recombinant protein comparator.

Recombinant OspA has been previously shown to be fully protective in mice when administered at much higher doses and with multiple bo.

Still, this study utilizes a single low-dose regimen that offers partial protection.

Finally, although mice were challenged by needle injection in this study, an OspA mRNA-LNP vaccine could be highly effective against ticks challenge representing the natural infection route.

The immunogenicity and protective efficacy of OspA mRNA-LNP outperformed alum-adjuvanted recombinant OspA protein, which is analogous to the LYMErix vaccine released by GSK in 1998. The LYMErix vaccine was later discontinued.

With further preclinical and clinical development, these researchers wrote that OspA mRNA-LNP could prove to be a viable preventative approach to curtailing the pervasiveness of Lyme disease.

This research was funded by the National Institute of Allergy and Infectious Diseases (R01AI146101, R01AI153064, AI126033, AI165499, AI138949, R01AI142572, R21AI137433, R01AI153064, and R01AI168312), the Steven and Alexandra Cohen Foundation, the Howard Hughes Medical Institute Emerging Pathogens Program, and the Burroughs Wellcome Fund (BWF1012376).

Sub Title:

OspA mRNA-LNP vaccine targets Lyme disease causing bacteria

References:

Development of an mRNA-lipid nanoparticle vaccine against Lyme disease

Penn Medicine Develops mRNA Vaccine Against Lyme Disease-Causing Bacteria

Lyme disease vaccine candidates - Sept. 2023

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Penn Medicine Development of an mRNA-lipid nanoparticle vaccine against Lyme disease August 2023

Lyme Disease Vaccine Candidate Tested in Sweden

Karen McClorey Hackett — Sat, 10 Jun 2023 17:31:37 +0000

Reviewer:

Robert Carlson, MD

A Professor of applied health technology at Blekinge Institute of Technology recently confirmed a Lyme disease vaccine candidate is being tested in Sweden.

Johan Sanmartin Berglund leads the Swedish part of phase 3 clinical study evaluating VLA15, a multivalent recombinant protein vaccine candidate targeting the outer surface protein A of Borrelia.

This innovative vaccine is designed for prophylactic, active immunization to protect people against most human pathogenic Borrelia species.

This is important news since over 10,000 people contract Lyme disease in Sweden, and the Blekinge region is known for having a high number of cases.

The risk of contracting a tickborne infection is determined by the number of ticks in an area, the proportion of those carrying the bacteria, and human behavior, such as walking in tick-infested fields.

A recent review showed substantial variability in reported Lyme disease incidence across and within European countries, with the highest incidences reported from the Eastern, Northern (Baltic states and Nordic countries), and Western Europe surveillance systems.

A previous study found the overall risk of developing Lyme borreliosis after a tick bite was 2.6% (95%CI 1.4–5.1).

In 1977, the first Lyme arthritis cases were described, and the Ixodes scapularis (black-legged) tick was linked to the disease transmission in Lyme, Connecticut.

A recent estimate based on insurance records suggests that approximately 476,000 people in the U.S. are treated for Lyme disease annually.

"It is difficult to produce a Lyme disease vaccine because the bacteria exist in many variants. In the preliminary study, we mapped which types of Lyme disease are found in Europe and which the vaccine needs to cover", commented Johan Sanmartin Berglund in a press release on May 24, 2023.

As of June 10, 2023, VLA15 is the only Lyme disease vaccine candidate currently in advanced clinical development.

Over 15,000 people are included in the clinical study, which has been underway for over a year, and it is time for the test persons to receive their third dose of vaccine.

"The vaccination study must last over at least two tick seasons. After that, it will take a few more years before the vaccine is approved and available in Europe. I estimate a new vaccine may be (commercially) available in 2026," concludes Johan Sanmartin Berglund.

Initially developed by France-based Valneva SE, the VLA15 vaccine candidate is an alum-adjuvanted formulation administered intramuscularly.

Valneva and New York-based Pfizer, Inc. announced a development and commercialization collaboration for VLA15 in April 2020. Pfizer currently leads the late-stage development and is controlling the vaccine's commercialization.

Sub Title:

VLA15 is a multivalent recombinant protein Lyme disease vaccine candidate

References:

Lyme disease vaccine is now being tested

Lyme Disease Vaccine (VLA15)

Lyme disease outbreaks 2023

Incidence of Lyme Borreliosis in Europe 2023

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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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Lyme Disease Vax Candidate Posts Positive Antibody Persistence Data

Donald Hackett — Thu, 01 Dec 2022 14:05:44 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

According to an announcement today, a Lyme disease vaccine candidate may soon obtain approval in the U.S. This would be significant since Lyme disease remains a serious health risk to most people.

This vector-borne illness is considered common in the Northern Hemisphere.

Each year, approximately 30,000 cases of Lyme disease are reported to U.S. CDC.

Earlier today, Pfizer Inc. and Valneva SE reported antibody persistence data six months after completing a three-dose or a two-dose vaccination schedule with their Lyme disease vaccine candidate.

This is the first time antibody persistence data have been reported in pediatric populations for the VLA15 vaccine candidate.

VLA15 is the only multivalent protein subunit Lyme disease vaccine candidate currently in clinical development.

Juan Carlos Jaramillo, M.D., Chief Medical Officer of Valneva, stated in a press release on December 1, 2022, "We are pleased with these antibody persistence data that further validate the use of the three-dose vaccination schedule in our ongoing Phase 3 study and the acceptable safety and tolerability profiles of our vaccine candidate."

"Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere, and each new report of positive data takes us a step closer to potentially bringing this vaccine to both adults and children who could benefit from it."

Earlier this year, Pfizer and Valneva initiated a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists, to investigate the efficacy, safety, and immunogenicity of VLA15.

Approximately 6,000 participants five years of age and older will receive three doses of VLA15 180 µg or saline placebo as a primary vaccination series followed by one booster dose of VLA15 or saline placebo (1:1 ratio).

Enrollment is ongoing in Europe and the U.S. and is expected to be completed in the second quarter of 2023.

To achieve the required pediatric safety database, Pfizer and Valneva plan to initiate a complementary Phase 3 clinical study in early December 2022 to collect additional VLA15 safety data in participants 5 to 17.

"Rates of Lyme disease continue to increase globally, underscoring the importance of a vaccine that may help protect both adults and children," commented Annaliesa Anderson, Ph.D., SVP and Chief Scientific Officer of Vaccine Research & Development at Pfizer.

"These six-month antibody persistence data are encouraging, and we hope that the data generated from the Phase 3 studies will further support the positive evidence for VLA15 to date."

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

Lyme disease is a systemic infection caused by Borrelia burgdorferi bacteria transmitted to humans by infected Ixodes ticks.

While the true worldwide incidence of Lyme disease is unknown, but it is estimated to affect approximately 130,000 people in Europe.

Early symptoms of Lyme disease, such as a gradually expanding erythematous rash called Erythema migrans, or more nonspecific symptoms like fatigue, fever, headache, mild stiff neck, arthralgia, or myalgia, are often overlooked or misinterpreted, says the CDC.

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

The medical need for vaccination against Lyme disease is steadily increasing as the geographic footprint of the disease widens.

PrecisionVaccinations publishes fact-checked, research-based vaccine information manually curated for mobile readers.

Sub Title:

VLA15 vaccine antibody levels remained above baseline at six months

References:

Valneva and Pfizer Report Six-Month Lyme Disease Antibody Persistence Data

CDC Lyme Disease

VLA15 phase 3 clinical trial

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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