Gonorrhea

Vaccine effectiveness and impact of meningococcal vaccines against gonococcal infections: A systematic review and meta-analysis

The Journal of Infection recently published insights on how vaccination can reduce the incidence of gonorrhea, a common sexually transmitted disease. Gonorrhea is one of the fastest-growing diagnoses by percent change (16.8%).

This new study's findings indicate that MenB vaccines may offer moderate protection against gonococcal infections.

Published on July 8, 2024, this systematic review and meta-analysis assessed the effectiveness of 4CMenB and MenB-OMV vaccines for meningococcal vaccination against gonococcal infections across 12 studies conducted in countries including the United States, New Zealand, Canada, Cuba, Australia, and Norway.

Modeling studies have suggested that even a partially effective vaccine could reduce the population prevalence of gonococcal infections by 35–60% within ten years and decrease incidence by up to 25% over 70 years.

These findings emphasize the potential value of incorporating meningococcal vaccination into strategies to control gonococcal infections, particularly in regions with high incidence rates and limited treatment options due to antibiotic resistance.

However, further research is needed to ascertain the factors associated with vaccine protection and to provide more substantial evidence for cost-effectiveness analysis. This will inform vaccination strategies for the more effective management of gonococcal infections.

Furthermore, other countries besides the United Kingdom should consider 4CMenB vaccination programs for those at high risk of gonococcal infection.

In the U.S., GSK's Bexsero® (MenB-4C) vaccine was U.S. FDA-approved for intramuscular injection in 2015 for 10- through 25-year-olds to prevent meningococcal group B disease caused by Neisseria meningitidis bacteria. As of 2024, people between the ages of 16 and 23 can receive the Bexsero vaccine based on 'shared clinical decision-making.'

This literature search was conducted in PubMed, Embase, Cochrane Library, CINAHL, Google Scholar, clinical trial registries, and major health and immunization conferences.

A meta-analysis was performed with the DerSimonian-Laird random-effects model to estimate the pooled VE.

All study authors receive no personal payments from the industry. The authors declare the following financial interests/personal relationships that may be considered potential competing interests: Helen Marshall is an investigator on vaccine trials sponsored by iILiAD Biotechnologies, Pfizer, and Sanofi. Helen Marshall’s institution receives funding for investigator-led studies from industry, including GSK, Pfizer, and Sanofi Pasteur.

Sub Title:

Bexsero Meningitis B vaccine availability for young adults based on shared clinical decision-making

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STD Diagnoses Rose 4.8 Percent from 2020 to 2023

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Chlamydia, Gonorrhea, Syphilis Prevention Now Includes Re-Purposed Products

Karen McClorey Hackett — Thu, 06 Jun 2024 19:25:04 +0000

Reviewer:

CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Preventi

While there are no U.S. FDA preventive vaccines and few chemoprophylaxis options targeting bacterial sexually transmitted infections (STIs), syphilis, chlamydia, and gonorrhea cases have increased in the United States.

In 2022, more than 2.5 million cases of syphilis, gonorrhea, and chlamydia were reported by the U.S. Centers for Disease Control and Prevention (CDC).

The most alarming concerns center around syphilis and congenital syphilis epidemics, signaling an urgent need for swift innovation and collaboration from all STI prevention partners, says the CDC.

On June 6, 2024, the CDC published its recommendation for the use of doxycycline postexposure prophylaxis (doxy PEP), a novel, ongoing, patient-managed biomedical STI prevention strategy for a selected population.

Doxycycline is a tetracycline antibiotic that generally treats infections by preventing the growth and spread of bacteria, such as acne and malaria.

The CDC now recommends that certain people who have had a bacterial STI diagnosed in the past 12 months should receive counseling that doxy PEP can be used as postexposure prophylaxis to prevent these infections.

Following shared decision-making with their healthcare provider, the CDC recommends that certain persons be offered a prescription for doxy PEP to be self-administered within 72 hours after having unprotected sex. The recommended dose of doxy PEP is 200 mg and should not exceed a maximum dose of 200 mg every 24 hours.

Furthermore, persons prescribed doxy PEP should undergo bacterial STI testing at anatomic exposure sites at baseline and every 3–6 months after that. Ongoing need for doxy PEP should be assessed every 3–6 months.

And HIV screening should be performed according to current CDC recommendations.

Seperately, in the United Kingdom, the Joint Committee on Vaccination and Immunisation recommended a targeted vaccination program in 2023 using the 4CMenB vaccine to prevent gonorrhea.

Various studies and real-world evidence suggest that the MenB vaccine provides cross-protection against gonorrhea. Two doses are estimated to reduce the chances of getting gonorrhea by 33%.

As of June 2024, the CDC has not issued a similar MenB vaccine recommendation.

Sub Title:

Doxycycline and MenB vaccination prevent bacterial sexually transmitted infections

References:

2022 STI Surveillance Report

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US CDC Bacterial STI Trends 2022

Gonorrhea Prevented With Meningococcal Vaccine

Karen McClorey Hackett — Fri, 10 Nov 2023 23:03:08 +0000

Reviewer:

JCVI advice on the use of meningococcal B vaccination for the prevention of gonorrhoea

Without an approved gonorrhea vaccine available, sexually transmitted disease (STD) researchers have been testing well-known bacteria-related vaccines for years.

Vaccine experts in the United Kingdom announced today they are advising certain at-risk people to consider being immunized with a meningococcal B vaccine.

On November 10, 2023, the Joint Committee on Vaccination and Immunisation (JCVI) published an Independent Report agreeing that a targeted program should be initiated using the 4CMenB vaccine for the prevention of gonorrhea in those who are at most significant risk of infection.

Professor Andrew Pollard, Chair of the JCVI, commented in a press release, "Introducing a MenB vaccination program to prevent gonorrhea in England would be a world first and should significantly help to reduce levels of gonorrhea, which are currently at a record high."

4CMenB is a 4-component serogroup B meningococcal vaccine that contains three main Neisseria meningitidis proteins: Neisseria heparin binding antigen; Neisserial adhesion A; factor H binding protein; and meningococcal serogroup B outer membrane vesicles (OMVs).

The only licensed 4-component vaccine currently available in the U.K. is Bexsero®, manufactured by GSK and authorized to prevent meningococcal disease in individuals aged two months and older.

The good news is the 4CMenB vaccine is currently used in routine childhood programs at eight weeks, 16 weeks, and one year to prevent meningococcal disease.

Unfortunately, STD data in 2022 from the U.K. Health Security Agency highlighted a rapid rise in gonorrhea diagnoses in England. The number of diagnoses in 2022 was the highest annual number on record.

This data follows an increasing trend in gonorrhea since the early 2000s.

Evidence of protection from meningococcal serogroup B vaccines has only been observed in OMV-containing vaccines such as 4CMenB and MenB OMV vaccines.

A recent observational study showed that the MenB-FHbp vaccine did not have an effect on gonorrhea infection and also provided evidence that this effect observed with the 4CMenB was not due to healthy vaccinee bias.

At the time of writing, several other studies are ongoing to examine immunogenicity and the potential vaccine effectiveness of 4CMenB in protection against gonorrhea in adolescent or young adult cohorts. Data from these studies will be reviewed by the JCVI once available.

A Research Letter published by The JAMA Network Infectious Diseases in August 2023 concluded that the OMV-based meningococcal group B vaccine was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among young adults aged 18 to 29.

In the U.S., gonorrhea vaccine candidates and treatments are currently being studied.

Sub Title:

Meningococcal B vaccination for the prevention of gonorrhea

References:

UK advises on gonorrhea vaccinations

Association of Group B Meningococcal Vaccine Receipt With Reduced Gonorrhea Incidence Among University Students

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Uncomplicated Super-Gonorrhea Treated with First-in-Class Oral Antibiotic

Karen McClorey Hackett — Thu, 02 Nov 2023 16:08:15 +0000

Reviewer:

Pivotal phase 3 trial of a first-in-class oral antibiotic to treat uncomplicated gonorrhea

The first study to address a World Health Organization (WHO) priority pathogen, gonorrhea, recently found positive preliminary findings that offer hope for patients, particularly in the face of rising antibiotic resistance to current regimens.

If approved, zoliflodacin will be the first new antibiotic for treating 'super-gonorrhea' in decades.

The Global Antibiotic Research & Development Partnership (GARDP), in collaboration with Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., announced on November 1, 2023, that zoliflodacin, a first-in-class antibiotic, met its primary endpoint in an unprecedented global pivotal phase 3 clinical trial.

Study investigators found that oral zoliflodacin demonstrated statistical noninferiority in microbiological cure at the urogenital site compared to treatment with intramuscular ceftriaxone and oral azithromycin, a current global standard of care regimen.

In this late-stage study, zoliflodacin was found to be generally well tolerated, and no serious adverse events or deaths were recorded.

The phase 3 trial enrolled a total of 930 patients with uncomplicated gonorrhea, including women, adolescents, and people living with HIV, making it the largest clinical trial ever conducted for a new treatment against gonorrhea infection, with 16 trial sites in regions with a high prevalence of gonorrhea across five countries, including Belgium, the Netherlands, South Africa, Thailand, and the U.S.

Dr. Manica Balasegaram, Executive Director of GARDP, commented in a related press release, "Despite the extremely high public health value, there has been a lack of investment to develop new drugs for gonorrhea."

"This zoliflodacin program demonstrates that it is possible to develop antibiotic treatments targeting multidrug-resistant bacteria that pose the greatest public health threat and which may not otherwise get developed."

With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the third most common sexually transmitted infection (STI), affecting both men and women.

If left untreated, gonorrhea can also cause infertility in women, life-threatening ectopic pregnancies, and pelvic inflammatory disease.

The bacterium Neisseria gonorrhoeae has gradually developed resistance to many classes of antibiotics used to treat these infections. As a result, ceftriaxone, given as a single intramuscular injection, has become the last available recommended treatment for gonorrhea globally.

The clinical trial compared a single oral 3g dose of zoliflodacin to a globally recognized standard of care regimen (500mg ceftriaxone plus 1g oral azithromycin) for the treatment of uncomplicated gonorrhea.

Zoliflodacin met the prespecified statistical test for noninferiority compared to ceftriaxone and oral azithromycin (5.31% (95%CI 1.38, 8.65%)).

Noninferiority of zoliflodacin was demonstrated within the prespecified margin of 12% and, furthermore, within the margin of 10% as specified in U.S. Food and Drug Administration guidance.

GARDP has the right to register and commercialize the product in more than three-quarters of the world's countries. Limited, an affiliate of Innoviva Specialty Therapeutics, retains commercial rights for zoliflodacin in the major markets in North America, Europe, Asia-Pacific, and Latin America.

The governments of Germany, the U.K., Japan, the Netherlands, Switzerland, and others funded this GARDP-led trial.

GARDP is a Swiss non-profit organization that develops new treatments for drug-resistant infections that pose the greatest threat to health. It was created by the World Health Organization and the Drugs for Neglected Diseases initiative in 2016 and legally founded in 2018.

As of November 2023, gonorrhea, like herpes, syphilis, and other STIs, does not have U.S. FDA-approved vaccines available.

However, a Research Letter published by the JAMA Network Infectious Diseases on August 31, 2023, concluded that an outer membrane vesicles-based meningococcal group B vaccine was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among recipients aged 18 to 29.

Sub Title:

Zoliflodacin inhibits a crucial bacterial enzyme called type II topoisomerase

References:

First treatment targeting ‘super-gonorrhoea’ passes trial

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Vaccination Significantly Protected College Students from Gonorrhea

Karen McClorey Hackett — Thu, 31 Aug 2023 20:41:43 +0000

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Association of Group B Meningococcal Vaccine Receipt With Reduced Gonorrhea Incidence Among University Students

A new Research Letter suggests meningococcal group B vaccination (MBV) offers significant protection against gonorrhea, a sexually transmitted disease.

Most women infected with gonorrhea do not have any symptoms. Even when a woman has symptoms, they are often mild and can be mistaken for a bladder or vaginal infection.

On August 31, 2023, the new research was published in the peer-reviewed journal JAMA Network Open, which assessed whether receipt of outer membrane vesicle (OMV) based MBV was associated with subsequent lower gonorrhea prevalence.

The Public Health Institutional Review Board covering Oregon's Public Health Division approved this case-control study's use of public health data.

The study's populations included 15,760 recipients of 1 or more OMV-based MBV (8510 females [54%], 7250 males [46%]; median [IQR] age at receipt, 19.3 [18-20] years).

And 15 212 recipients of 1 or more non–OMV–based MBV (8519 females [56%], 6693 males [44%]; median [IQR] age at receipt, 19.4 [18-20] years).

Overall, 53% of non–OMV–based MBV recipients received more than one dose vs. 57% of OMV-based MBV recipients.

Twenty-four cases of gonorrhea were reported in OMV-based MBV recipients vs. 44 patients in non–OMV–based MBV recipients.

The OMV-based MBV was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among recipients aged 18 to 29.

Among those aged 18 to 19, 12 gonorrhea cases were reported in OMV-based MBV recipients and 27 in non–OMV–based MBV recipients (vaccine effectiveness, 59%; 95% CI, 20%-79%).

However, vaccine effectiveness for recipients of 2 or more vaccines vs. one vaccine was 11% (95% CI, –0.98% to 0.60%).

These researchers wrote the study's 'results were consistent with other study findings that OMV-based vaccines may offer protection against gonorrhea.'

Given the global burden of gonorrhea, further investigation of OMV-based vaccination technology may be warranted, concluded these researchers.

This study's limitations included low numbers of gonorrhea cases, the likelihood of students graduating and leaving the disease-reporting area, and shifts in gonorrhea risk over time.

Because both MBVs were used at each university, this study reduced the selection bias inherent in retrospective, population-based studies. And there were no industry-related conflicts of interest disclosed.

Currently, two meningococcal vaccines are available in the U.S.: MenB-4C (OMV-based) and MenB-FHbp (not OMV-based).

The U.S. Centers for Disease Control and Prevention (CDC) reported about 710,000 cases of gonorrhea in 2021, making it the second most common sexually transmitted infection in the U.S. In addition, the CDC announced on April 11, 2023, that gonorrhea rates increased by more than 4% in 2022.

The CDC recommends meningococcal vaccines for preteens, teens, and certain other people in the U.S. A booster dose at 16 years old gives teens continued protection when they are at the highest risk.

Sub Title:

Gonorrhea infections reduced following meningococcal group B vaccination

References:

Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand

US CDC - gonorrhea

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England's Sexually Transmitted Disease Outbreaks Set Records

Karen McClorey Hackett — Tue, 06 Jun 2023 15:14:31 +0000

Reviewer:

Sexually transmitted infections and screening for chlamydia in England

New data announced today by the UK Health Security Agency (UKHSA) indicates record levels of chlamydia, gonorrhea, and syphilis were diagnosed in England during 2022.

Published on June 6, 2023, this new UKHSA report analyzes the 400 sexually transmitted infections (STIs) diagnoses made daily in 2022.

The latest data shows gonorrhea diagnoses totaled 82,592 in 2022, an increase of 50.3% in one year. This is the most significant number of gonorrhea diagnoses in any one year since 1918.

And infectious syphilis diagnoses increased to 8,692 in 2022, up 15.2% compared to 2021.

This is the largest annual number of syphilis cases since 1948.

Furthermore, chlamydia diagnoses increased by 24.3% to reach 199,233 in 2022.

While the increase in gonorrhea and syphilis diagnoses is in part due to testing, the scale of the increase in diagnoses strongly suggests there is more transmission of STIs within England's population, wrote the UKHSA.

Dr. Hamish Mohammed, Consultant Epidemiologist at UKHSA, commented in a related press release, "We saw more gonorrhea diagnoses in 2022 than ever before, with large rises, particularly in young people."

"STIs aren't just an inconvenience – they can have a major impact on your health and that of any sexual partners."

"Testing is important because you may not have any symptoms of an STI."

Though STIs are usually easily treated with antibiotics, many can cause serious health issues if left untreated.

For example, chlamydia and gonorrhea can cause infertility and pelvic inflammatory disease, while syphilis can cause serious, irreversible, and potentially life-threatening problems with your brain, heart, or nerves.

Unfortunately, these STIs do not have approved vaccines available in 2023.

However, a study published in Clinical Infectious Diseases in June 2022 suggested that a meningococcal serogroup B (MenB-4C) vaccine may offer cross-protection against gonorrhea infection.

And in France, meningococcal vaccination is recommended against gonorrhea.

Other STIs, such as human papillomavirus and mpox, can be prevented with approved vaccines.

Sexually Transmitted Disease vaccine news is posted by Precision Vaccinations.

Sub Title:

Sexually transmitted infections can be prevented

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Gonorrhoea and syphilis at record levels in 2022

UK - Sexually transmitted infections (STIs): annual data tables

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Oral Gonorrhea Treatment Study Proceeds

Karen McClorey Hackett — Wed, 24 May 2023 21:37:08 +0000

Reviewer:

GARDP announces completion of patient recruitment for registrational phase 3 gonorrhoea treat

Without an approved vaccine preventing gonorrhea infections, there is significant demand for innovative treatments for millions of people each year.

To meet that need, the Global Antibiotic Research & Development Partnership (GARDP) and Innoviva Specialty Therapeutics today announced the completion of recruitment for their global phase 3 pivotal registration trial of oral zoliflodacin, an investigational, first-in-class antibiotic being developed for the treatment of uncomplicated gonorrhoea infection in patients.

The top-line results from this phase 3 trial are expected in Q4 of 2023.

In 2017, GARDP partnered with Entasis Therapeutics Limited to conduct a study at 16 sites across Belgium, the Netherlands, South Africa, Thailand, and the U.S., comparing zoliflodacin to a globally recognized regimen (500mg ceftriaxone plus 1g azithromycin) for the treatment of uncomplicated gonorrhoea.

The first patient was recruited in the U.S. in November 2019, and the trial continued, despite obstacles, throughout the recent pandemic.

A total of 958 patients were recruited, making it the largest clinical trial ever conducted for a new treatment against gonorrhoea infection.

“Completion of study enrollment allows us to move forward to better understand how zoliflodacin may work to address the ongoing threat of progressive gonococcal antimicrobial resistance in patients,” said Dr. Edward W. Hook III, Emeritus Professor of Infectious Diseases at the University of Alabama at Birmingham, and Global Protocol Chair for the zoliflodacin trial, in a press release on May 23, 2023.

“It is our hope this novel approach will yield an oral alternative to currently recommended therapy, which can only be administered by injection.”

Gonorrhoea is among the three most common sexually transmitted infections, and it affects men and women, particularly ages 15-24 years old.

Globally, the infection rate of gonorrhoea is increasing, with 82 million new cases estimated each year and minimal treatment options due to antimicrobial resistance.

The U.S. CDC announced on April 11, 2023, gonorrhoea rates increased by more than 4% last year, reaching 710,151 in 2022.

In addition, recent outbreaks of extensively drug-resistant gonorrhoea to the last-line treatment option have been reported in the U.S. and the U.K.

Gonorrhoea can have serious and permanent consequences, particularly for women, including infertility, life-threatening ectopic pregnancies, and pelvic inflammatory disease.

Gonorrhoea is caused by the bacterium Neisseria gonorrhoeae, which has progressively developed resistance to globally recommended treatments and has been identified by the World Health Organization as a “priority pathogen,” posing one of the greatest threats to global health.

As of May 24, 2023, no approved gonerrhoea vaccine is available.

Precision Vaccinations post other sexually transmitted disease vaccine news.

Sub Title:

Zoliflodacin is a first-in-class antibiotic for uncomplicated gonorrhoea treatment

References:

Zoliflodacin: An Oral Spiropyrimidinetrione Antibiotic

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Meningococcal Vaccination May Offer Gonorrhea Protection

Don Hackett — Thu, 02 Jun 2022 11:36:17 +0000

Reviewer:

Prevention of Neisseria gonorrhoeae with meningococcal B vaccine: a matched cohort study in Southern California

A new study published today in Clinical Infectious Diseases suggests that a meningococcal serogroup B vaccine may offer cross-protection against gonorrhea infection.

This new research joins recent studies from Canada, Norway, and New Zealand that also indicated that meningococcal vaccines might be protective against Neisseria gonorrhoeae.

These findings are essential since Neisseria gonorrhoeae is acquiring increasing resistance to available oral antibiotics, and current screening and treatment approaches have not decreased overall gonorrhea incidence.

Published on June 1, 2022, this study was a matched cohort study from 2016 to 2020 to examine the association of OMV-containing recombinant meningococcal serogroup B vaccine (4CMenB) with gonorrhea infection among teens and young adults at Kaiser Permanente Southern California.

The study's results included 6,641 recipients of the 4CMenB (Bexsero) Meningitis B vaccine matched to 26,471 recipients of MenACWY.

During follow-up, gonorrhea incidence rates per 1000 person-years (95% CI) were 2.0 (1.3-2.8) for recipients of 4CMenB and 5.2 (4.6-5.8) for recipients of MenACWY.

In adjusted analyses, gonorrhea rates were 46% lower among recipients of 4CMenB vs MenACWY (HR [95% CI] 0.54 [0.34-0.86]).

But chlamydia rates were similar between vaccine groups (HR [95% CI] 0.98 [0.82-1.17]).

"These results are aligned with prior observational studies and lend support to ongoing randomized controlled trials of the effectiveness of 4CMenB against gonorrhea," wrote these researchers.

"As rates of antibiotic-resistant gonorrhea continue to increase, renewed attention to vaccination strategies is paramount to preventing untreatable gonorrhea disease."

A recent observational study published in 2022 focused on New York City and Philadelphia from 2016-to 2018. Its results indicated two doses of the 4CMenB vaccine provided about 40% protection against gonorrhea.

In the USA, antibiotics have successfully treated gonorrhea for several decades; however, the bacteria has developed resistance to nearly every drug used for treatment, says the U.S. CDC. In 2020, about half of all infections were estimated to be resistant to at least one antibiotic.

In 2020, over 677,000 cases of gonorrhea were reported to the CDC, making it the second most common notifiable sexually transmitted infection. Even during the early COVID-19 pandemic shutdown period of 2019–2020, the overall rate of reported gonorrhea increased by 5.7%.

GSK's Bexsero® vaccine was initially approved in the USA in 2015. Bexsero is indicated for active immunization of individuals from two months through 17 years old against invasive disease caused by Neisseria meningitidis serogroup B strains.

Historically, MenB first-dose vaccine coverage in the US is low and even lower for a second dose, with regional variation. MenB vaccination coverage among 17-year-olds increased from 14.5% in 2017 to 17.2% in 2018 for ≥1 dose and from 6.3% to 8.4% for ≥2 doses. And coverage with two doses of MenACWY was about 54% in 2020.

The CDC's updated vaccination schedule was posted on February 17, 2022. And GSK's recommended vaccination schedule was updated in 2021.

PrecisionVaccination publishes fact-checked, research-based news curated for mobile readership.

Sub Title:

Gonorrhea-specific preventive vaccines do not exist

References:

Effectiveness of a serogroup B outer membrane vesicle meningococcal vaccine against gonorrhoea: a retrospective observational st

Outer membrane vesicle vaccines for Neisseria gonorrhoeae

Exploitation of Neisseria meningitidis Group B OMV Vaccines Against N. gonorrhoeae to Inform the Development and Deployment of E

CDC: National Overview of STDs, 2020

Bexsero Meningitis B Vaccine

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Vaccine Candidate Receives Funding to Combat ‘Super Gonorrhea’

Don Hackett — Tue, 30 Mar 2021 15:04:45 +0000

Reviewer:

CARB-X IS FUNDING UNIVERSITY OF OXFORD’S JENNER INSTITUTE TO DEVELOP A NEW VACCINE TO PREVENT GONORRHEA

Massachusetts-based CARB-X announced today it awarded up to $2 million to the Jenner Institute, part of the University of Oxford, UK, to develop a novel vaccine to prevent gonorrhea.

The Jenner Institue‘s gonorrhea vaccine, dmGC_0817560 NOMV, consists of blebs, or fluid-filled blisters, from the outer surface of gonococcus, called Native Outer Membrane Vesicles (NOMV).

Jenner’s findings to date suggest the vaccine would prevent infections from ‘super’ strains of gonococcal bacteria, including the most powerful multidrug-resistant strains that are spreading globally at an alarming pace.

The project is currently in Lead Optimization, a crucial early development phase in which the most promising preclinical vaccine candidate is identified.

The CARB-X award supports Optimization work and scale-up, followed by the production of vaccines in the University’s Clinical Biomanufacturing Facility for a first-in-human study.

The Institute would be eligible for up to $5.3 million more if the project progresses through certain project milestones, subject to available funding under the award.

“The Jenner Institute at Oxford University is delighted to be partnering with CARB-X in the development of a new vaccine against gonorrhea, which will be an essential weapon in the battle against antibiotic-resistant bacteria,“ commented Professor Adrian Hill, Director of the Jenner Institute, in a related press release.

Working alongside the Oxford Vaccine Group, researchers aim to produce an affordable vaccine for global use. The intent is that the vaccine will induce protective immunity against gonorrhea that will prevent individuals from developing the disease and interrupt the spread of antibiotic resistance found in gonococcal bacteria.

Drug-resistant Neisseria gonorrhea is identified by the World Health Organization (WHO) as a ‘priority’ pathogen and classified by the US Centers for Disease Control and Prevention (CDC) as an ‘urgent public health threat that requires aggressive action.

Gonorrhea has developed resistance to most antibiotics, with only one class remaining effective in the treatment of the disease.

Gonorrhea spreads easily as many of those infected do not have symptoms and may not know they are infected. Gonorrhea can cause pelvic inflammatory disease and infertility in women, and sterility in men. Babies born to an infected woman can develop blindness.

The WHO estimates that about 78 million people a year are infected with gonorrhea.

However, at the global level, gonorrhea is principally a disease of low- and middle-income countries (LMICs). While the WHO estimated global prevalence of urogenital gonorrhea in 2016 is 0.9% in women and 0.7% in men, in the African Region prevalence, rises to 1.9% in women and 1.6% in men.

Since healthcare facilities in LMICs are often sparse and ill-equipped, particularly in the poorest countries of sub-Saharan Africa, the vast majority of infections go untreated.

This vaccine is produced using simple and easily transferrable technologies that could allow the vaccine to be made by manufacturers in LMIC settings.

A non-profit partnership, CARB-X receives its funding from the US Biomedical Advanced Research and Development Authority (BARDA), the Wellcome Trust, the UK Global Antimicrobial Resistance Innovation Fund (GAMRIF), Germany’s Federal Ministry of Education and Research (BMBF), and the Bill & Melinda Gates Foundation.

CARB-X earmarks the funding contributions from GAMRIF to fund projects that focus on specific antibacterial priorities, and the Jenner project is one such project.

The CARB-X portfolio is the world’s most extensive and most diverse antibacterial portfolio, with 56 active projects focused exclusively on drug-resistant bacteria. CARB-X is investing up to $480 million in non-dilutive funding between 2016-2022 to support the early development of new antibiotics and other therapeutics, vaccines, and other preventatives, rapid diagnostics.

The goal is to support therapeutic and preventative projects through the early phases of development, including Phase 1, to attract additional private or public support for further clinical development and regulatory approval for use in patients.

PrecisionVaccinations publishes research-based vaccine development news.

Sub Title:

Jenner Institute gonorrhea vaccine, dmGC_0817560 NOMV, consists of Native Outer Membrane Vesicles

References:

Advancing a native outer membrane vesicle vaccine against gonorrhoea towards clinical development

A Meningococcal Native Outer Membrane Vesicle Vaccine With Attenuated Endotoxin and Overexpressed Factor H Binding Protein Elici

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Gonorrhea Vaccine Candidate Displays Pre-Clinical Effectiveness

Don Hackett — Sun, 17 Nov 2019 13:29:39 +0000

Reviewer:

Preclinical Efficacy of a Lipooligosaccharide Peptide Mimic Candidate Gonococcal Vaccine

The global spread of multidrug-resistant strains of Neisseria gonorrhoeae constitutes a public health emergency. The U.S. Centers for Disease Control and Prevention (CDC) has identified multidrug-resistant gonococci a hazard-level threat to the U.S. population.

Antibiotics have successfully treated gonorrhea for decades, however, the bacteria has developed resistance to nearly every drug used for treatment.

With limited antibiotic treatment options, there is an urgent need for the development of a safe and effective vaccine against gonorrhea, said a team of researchers from the UMass Medical School in a November 5, 2019, press release.

The UMass team has developed and tested in mice a gonococcal vaccine candidate called TMCP2, when administered, it elicited bactericidal IgG and reduced colonization levels of gonococci while accelerating clearance by each of 2 different gonococcal strains.

Furthermore, these UMass researchers say ‘the TMCP2 vaccine can be scaled up and produced economically to a high degree of purity.’

This is important news since there is no gonococcal vaccine that effectively prevents or curtails gonorrhea in humans commercially available today.

The CDC says ‘sexually active women younger than 25 years or women with new or multiple sex partners, or a sex partner who has an STD should be tested every year. If gonorrhea is left untreated, it can cause infertility in women.

And, a pregnant woman with gonorrhea can give the infection to her baby during childbirth.

Peter A. Rice, M.D., a professor of medicine in the Division of Infectious Diseases and Immunology, and senior author of this new report published in the journal mBio, said “The UMMS team has developed a gonococcal vaccine candidate, a complex peptide that is both scalable and economically produced to a high degree of purity.”

“The candidate elicits bactericidal (killing) antibodies and is efficacious in a preclinical experimental infection model.”

A new report in the journal mBio, published by the American Society for Microbiology, describes a prototype vaccine candidate for Neisseria gonorrhoeae.

The TMCP2 vaccine a synthetic compound represents a mimic of a highly represented molecule on the surface of gonococcal organisms that is replicated many times on its surface and is shared by almost all gonococci, while also serving as the target of vaccine-elicited antibody.

The vaccine formulation also includes an adjuvant to increase the immune response against the organism.

TMCP2 was tested over a range of doses and administration intervals in an animal model. The vaccine elicited a durable and robust immune response, one that significantly reduced both the duration of infection and the level of gonococcal colonization.

With 580,000 cases reported in the United States in 2018, gonorrhea has increased 63 percent in the past 5-years in the USA.

Some men with gonorrhea may have no symptoms at all. However, men who do have symptoms may have a burning sensation when urinating.

Most women with gonorrhea do not have any symptoms.

Even when a woman has symptoms, they are often mild and can be mistaken for a bladder or vaginal infection. Women with gonorrhea are at risk of developing serious complications from the infection, even if they don’t have any symptoms, says the CDC.

“This TMCP2 vaccine is the most promising Gonorrhea candidate developed in 40 years,” said Dr. Rice, one that he and his colleagues are poised to navigate through in additional preclinical studies toward FDA approval and a clinical trial.

“From a public health perspective, even a decrease in burden and duration of infection can have profound effects on disease pathology and transmission.”

“In addition, prevention represents an important goal in the development of a safe, economical and effective gonococcal vaccine that can be used in resource-limited areas, such as Africa, where rates of gonorrhea are high,” concluded Dr. Rice.

A 2017 study found adults in South Africa, between 15-49 years of age, have an estimated 6.6 percent prevalence of gonorrhea.

Recent gonorrhea vaccine news

October 23, 2019 – Researchers at the University of Alabama at Birmingham were awarded a 3-year contract to study the efficacy of the meningitis vaccine Bexsero in protecting populations from infection, with the bacteria that causes gonorrhea.
May 11th, 2019 – The National Institute of Allergy and Infectious Diseases announced financial awards of $41.6 million dollars to establish Cooperative Research Centers focused on developing vaccines to prevent sexually transmitted infections. These grants will support collaborative, multidisciplinary research on the bacteria that cause syphilis, gonorrhea, and chlamydia.

Other authors on this report include Sunita Gulati, DSc, associate professor of medicine; Sanjay Ram, MD, professor of medicine; and Michael W. Pennington, Ph.D., of AmbioPharm, Inc.

Gonorrhea vaccine news published by Precision Vaccinations.

Sub Title:

TMCP2 vaccine candidate in combination with glucopyranosyl lipid A-stable oil-in-water nanoemulsion elicited bactericidal IgG and reduced colonization levels of gonococci

References:

Vaccine candidate for gonorrhea developed at UMass Medical School shows preclinical effectiveness

Adult gonorrhea, chlamydia and syphilis prevalence, incidence, treatment and syndromic case reporting in South Africa

CDC: Antibiotic-Resistant Gonorrhea

CDC: Gonorrhea

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$10 Million Dollars for Gonorrhea Prevention Vaccine Study

Don Hackett — Wed, 23 Oct 2019 14:11:04 +0000

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Kelley Lu, PharmD

NIH study to explore vaccine for gonorrhea prevention

Researchers at the University of Alabama at Birmingham have been awarded a 3-year contract with a total potential amount of $10 million dollars to study the efficacy of the meningitis vaccine Bexsero in protecting populations from infection, with the bacteria that causes gonorrhea.

This new phase II study is the only large-scale trial to study a preventive vaccine for gonorrhea.

This study is good news since the gonorrhea bacteria has developed resistance to antibiotics, and having a preventive vaccine available could have a major impact on reducing healthcare costs.

The contract from the National Institute of Allergy and Infectious Diseases (NIAID) is for $3.5 million in 2019, with the total funding depending on how the study progresses.

Bexsero contains different proteins taken from group B Neisseria meningitidis bacteria. Bexsero could have a tremendous impact on the growing public health problem of increasing rates of gonorrhea and other sexually transmitted infections (STI).

There are more than 580,000 newly diagnosed cases of gonorrhea in the United States each year. This study will help researchers get closer to determining how to protect people from contracting gonorrhea, as antibiotic resistance rates increase.

Previously, the U.S. Centers for Disease Control identified multidrug-resistant gonococci as among 3 “urgent” hazard-level threats to the U.S. population.

The World Health Organization estimates that there were 78 million cases of gonorrhea worldwide in 2012. Despite control efforts, the causative agent of gonorrhea, the Gram-negative species Neisseria gonorrhoeae (the gonococcus, or GC), has accumulated antibiotic resistance such that it has achieved multidrug resistance (MDR) status.

“A vaccine for this infection could enhance the reproductive and sexual health of millions of people globally. It’s really exciting,” said Jeanne Marrazzo, M.D., MPH, director of UAB’s Division of Infectious Diseases and principal investigator of the study, in a press release.

Approximately 2,000 volunteers at risk for gonorrhea will be enrolled at lead site UAB and partner sites. They will be randomly assigned to either Bexsero or a placebo injection and observed to follow their risk of getting gonorrhea over time.

All study participants will be counseled on the best ways to avoid becoming infected with STI, including HIV.

These UAB researchers hope that, in addition to studying whether Bexsero helps prevent new gonorrhea infections, they will also be able to determine more about how this protection happens.

If left untreated, STIs may cause complications, including pelvic inflammatory disease, ectopic pregnancy, postpartum endometriosis, infertility, and chronic abdominal pain in women; adverse pregnancy outcomes, including abortion, intrauterine death, and premature delivery; neonatal and infant infections and blindness; urethral strictures and epididymitis in men; genital malignancies; proctitis, colitis, and enteritis in MSM; arthritis secondary to gonorrhea and chlamydia; liver failure and liver cancer secondary to hepatitis B virus (HBV); myelopathy and lymphoma or leukemia due to human T-cell lymphotropic virus type 1; and central nervous system disease or meningoencephalitis secondary to syphilis or herpes simplex virus (HSV) infection.

Direct medical costs for eight major STIs have been estimated at US $16.7 billion in the United States. This estimate includes costs in the United States in 2008 for gonorrhea, chlamydia, syphilis, trichomoniasis, hepatitis B, diseases associated with sexually transmitted HPV, genital HSV-2 infections, and HIV infection.

This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201300012I.

Gonorrhea Vaccine information published by Precision Vaccinations

Sub Title:

Bexsero vaccination could have a tremendous impact on the increasing rates of gonorrhea

References:

Sexually Transmitted Infections: Impact and Cost-Effectiveness of Prevention

Summary and Recommendations from the National Institute of Allergy and Infectious Diseases (NIAID) Workshop “Gonorrhea Vaccines

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$41.6 Million Dollars Awarded For Syphilis, Gonorrhea, and Chlamydia Vaccine Research

Don Hackett — Sat, 11 May 2019 17:32:32 +0000

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NIH awards will advance development of vaccines for sexually transmitted infections

Kelley Lu, PharmD

The National Institute of Allergy and Infectious Diseases (NIAID) announced financial awards of $41.6 million dollars to establish Cooperative Research Centers (CRCs) focused on developing vaccines to prevent sexually transmitted infections (STIs).

These grants will support collaborative, multidisciplinary research on the bacteria that cause syphilis, gonorrhea, and chlamydia.

Moreover, these STIs can cause long-term health problems and problems during pregnancy.

“STI research has recently evolved rapidly on multiple fronts, and this new knowledge can now be applied to a critical remaining challenge — the development of safe and effective vaccines for diseases that pose significant and growing public health burdens,” said NIAID Director Anthony S. Fauci, M.D.

These 3 STIs impacted over 2.2 million USA residents in 2017.

“Research at these new CRCs should help fill the pipeline with several vaccine candidates that have feasible pathways to licensure in the U.S,” said Dr. Fauci in a press release.

These CRCs are funded through this new program will conduct at least 3 research projects organized on a common theme.

One center, based at the UConn Health School of Medicine, will receive up to $11 million over 5 years to study syphilis, which is the 2nd leading cause of miscarriage and stillbirth worldwide.

Two of the centers are focused on gonorrhea, an STI caused by Neisseria gonorrhoeae. Especially concerning is the fact that the bacteria that cause gonorrhea have become resistant to most antibiotics.

A 4th center, based at the University of North Carolina (UNC) at Chapel Hill will receive up to $10.7 million over 5 years to advance chlamydia vaccine research. Chlamydia trachomatis is the most common sexually transmitted bacterial pathogen in the world.

Most chlamydia infections are asymptomatic, but untreated chlamydia infections in women can lead to pelvic inflammatory disease or infertility and have been linked to ovarian cancer.

The NIAID conducts and supports research throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases and to develop better means of preventing, diagnosing and treating these illnesses.

News releases, fact sheets, and other NIAID-related materials are available on the NIAID website.

Click here for more information about NIH and its programs.

Sub Title:

Vaccines are needed for Herpes (HSV) and other sexually transmitted infections

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Women's Health Care Physicians

Sexually Transmitted Disease Surveillance 2017

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Bexsero MenB Vaccine May Offer Gonorrhea Protection

Don Hackett — Fri, 21 Dec 2018 20:09:45 +0000

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The serogroup B meningococcal vaccine Bexsero elicits antibodies to Neisseria gonorrhoeae

Kelley Lu, PharmD

New research indicates that the meningococcal B vaccine Bexero may offer cross-protection against gonorrhea.

Bexsero, which is FDA-approved to prevent invasive disease caused by Neisseria meningitidis serogroup B, for individuals 10 to 25 years of age, includes the MeNZB OMV component plus 3 recombinant antigens, NadA, fHBP-GNA2091 and NHBA-GNA1030.

This research found there is a high level of sequence identity between MeNZB OMV and Bexsero OMV antigens, and gonococcal proteins in test rabbits.

This study’s conclusion said ‘the anti-gonococcal antibodies induced by MeNZB-like OMV proteins could explain the previously seen decrease in gonococcal cases following MeNZB vaccination.

And, the high level of anti-gonococcal-NHBA antibodies generated by Bexsero vaccination in humans may result in additional cross-protection against gonorrhea.

Gonorrhea is the 2nd most commonly reported notifiable disease in the USA.

Gonorrhea is a sexually transmitted disease caused by infection with the Neisseria gonorrhoeae bacterium.

N. gonorrhea infects the mucous membranes of the reproductive tract, including the cervix, uterus, and fallopian tubes in women, and the urethra in women and men, according to the US Centers for Disease Control and Prevention (CDC).

This new study builds on a 2017 report that the outer membrane vesicle (OMV) meningococcal B vaccine, MeNZB, was reported to be associated with reduced rates of gonorrhea following a mass vaccination campaign in New Zealand.

To probe the basis for this protection we assessed cross-reactivity to N. gonorrhea of serum raised to the meningococcal vaccine Bexsero, which contains the MeNZB OMV component plus three recombinant antigens (NadA, fHBP-GNA2091, and NHBA-GNA1030).

This new information is important since gonorrhea is becoming increasingly difficult due to widespread antibiotic resistance, says the CDC.

In 2017, 555,608 cases of gonorrhea were reported to CDC.

While vaccines are routinely used for N.meningitidis, no vaccine is available for N.gonorrhea.

"We have all the knowledge and technology to make a real gonorrhea vaccine," said the producer of Bexero, GSK, in an interview during November 2018.

This study’s results may lead to human clinical trials.

These Australian researchers included Evgeny A Semchenko, Aimee Tan, ay Borrow, and Kate L Seib, Institute for Glycomics, Griffith University, Gold Coast, Australia.

Address correspondence to Kate L. Seib: k.seib@griffith.edu.au.

See the disclosures for potential conflicts of interest.

Sub Title:

Serogroup B meningococcal vaccine Bexsero reported to elicit antibodies to Neisseria Gonorrhea

References:

Effectiveness of a group B outer membrane vesicle meningococcal vaccine against gonorrhoea in New Zealand: a retrospective case

Gonorrhea - CDC Fact Sheet

Bexsero

Glaxo considers developing Gonorrhea vaccine as threat rises

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Washington DC Leads in Sexually Transmitted Diseases

Don Hackett — Sun, 30 Sep 2018 19:22:52 +0000

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