Meningococcal Group B Vaccine for Gonorrhea

Not currently recruiting at 14 trial locations

Overseen By Jodie Dionne

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must not be taking: Antibiotics, Immunosuppressants, Corticosteroids

Disqualifiers: Meningococcal vaccine, Gonorrhea, Chlamydia, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 2 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a vaccine, originally designed for Meningococcal Group B, can prevent gonorrhea infections. Participants will receive either the Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) or a placebo (a harmless, inactive substance), and researchers will compare the results. The trial seeks men and women aged 18-50 who are at a higher risk of contracting gonorrhea. Those who have not received a Meningococcal Group B vaccine and are generally healthy may be suitable candidates. The study will last approximately 16 months for participants. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive agents or systemic corticosteroids, you may not be eligible to participate. It's best to discuss your specific medications with the trial staff.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the Meningococcal Group B Vaccine, known as Bexsero, is generally safe. Studies have found that vaccines like Bexsero, which protect against meningococci, are effective and safe. For instance, similar vaccines have been about 30-40% effective in preventing gonorrhea, with no major safety issues reported.

The FDA has already approved Bexsero for other uses, such as preventing meningitis, indicating it has passed strict safety tests for those purposes. While all vaccines can cause side effects, current evidence suggests that Bexsero is a safe choice for most people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for gonorrhea?

Unlike the standard treatments for gonorrhea, which typically involve antibiotics like ceftriaxone, the meningococcal Group B vaccine (Bexsero) offers a novel approach by using a vaccine initially designed for a different bacteria. Researchers are excited about Bexsero because it targets gonorrhea in a completely new way, harnessing the immune system to fight off the infection rather than relying on antibiotics. This is particularly important given the rising concern of antibiotic resistance. By using the rMenB+OMV NZ components, the vaccine could potentially provide long-lasting protection and reduce the spread of gonorrhea, which is a major public health goal.

What evidence suggests that the Meningococcal Group B Vaccine might be an effective treatment for gonorrhea?

Research has shown that the Bexsero vaccine, typically used to prevent meningococcal disease, might also help prevent gonorrhea. In this trial, participants in Group 1 will receive the Bexsero vaccine. Studies have found that vaccines like Bexsero can lower gonorrhea rates by about 30-47%. One study found the vaccine to be 38% effective in preventing gonorrhea, while another study showed it was 47% effective in young adults aged 18 to 29. These results suggest the vaccine could help reduce gonorrhea infections. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-50 who are in good health, not pregnant or breastfeeding, and have not had gonorrhea or chlamydia recently. They shouldn't have received a Meningococcal Group B vaccine before or taken certain antibiotics or immunosuppressants recently.

Inclusion Criteria

Participant is in good health as determined by past medical history, medication use, and targeted physical examination (including vital signs), in opinion of investigator or their delegate

Willing and likely to comply with the trial procedures

Is prepared to grant authorized persons access to the study's medical records

Exclusion Criteria

Participant is breastfeeding

I have not had cancer treatment or radiation in the last 90 days.

I have been on immunosuppressants or steroids (like prednisone) for more than 2 weeks in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-6 weeks

1 visit (in-person)

Treatment

Participants receive two doses of the study product (Bexsero or placebo) administered as intramuscular injections, two months apart

2 months

2 visits (in-person), 1 visit (phone call)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with clinic visits at 3-month intervals

14 months

4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero)

Trial Overview The study tests the effectiveness of the Bexsero vaccine against gonorrhea compared to a placebo. Participants won't know which they receive. The trial involves around 2,200 people and lasts about 16 months per participant.

How Is the Trial Designed?

Group I: Group 1 Experimental Treatment 1 Intervention

Bexsero vaccine will be administered as an intramuscular injection in 1 mL single-dose prefilled syringe in two doses with a two-month apart (at enrollment/Visit 1 and Visit 3). N=1100.

Group II: Group 2 Placebo Group 1 Intervention

Placebo will be administered as an intramuscular injection in single-dose prefilled syringe in two doses with a two-month apart (at enrollment/Visit 1 and Visit 3). N=1100.

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Published Research Related to This Trial

A review of 1,867 adverse event reports following the administration of the MenB-4C vaccine showed that 96% of these reports were classified as non-serious, indicating a favorable safety profile for the vaccine.

The most common adverse events reported were injection site pain, fever, and headache, which align with the expected safety outcomes from clinical studies, suggesting no new safety concerns have emerged since the vaccine's approval.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018. Perez-Vilar, S., Dores, GM., Marquez, PL., et al.[2023]

The introduction of the Bexsero® meningococcal B vaccine into Spain's routine vaccination schedule could prevent 54% of invasive meningococcal disease cases and deaths with a 3+1 dosage, but it is currently not cost-effective at the existing price, with an incremental cost-utility ratio (ICUR) of 351,389 €/QALY.

For the vaccine to be considered cost-effective, the price would need to be reduced to 1.45 € for the 3+1 dosage or 3.37 € for the 2+1 dosage, indicating that pricing plays a crucial role in vaccine policy decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Economic evaluation of the introduction of 4CMenB (Bexsero®) in the national vaccine schedule in Spain]. Ruiz-Montero, R., Epstein, D., Guzmán Herrador, B., et al.[2021]

The protein-based meningococcal group B vaccine Bexsero(®) may provide some protection against secondary infections, but its early effectiveness after a single dose is low, especially in young children who are at higher risk.

The estimated number needed to vaccinate (NNV) to prevent one secondary case is over 1000 in household settings, indicating that while Bexsero(®) could be useful in outbreaks, its practical application for individual cases may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preventing secondary cases of invasive meningococcal capsular group B (MenB) disease using a recently-licensed, multi-component, protein-based vaccine (Bexsero(®)). Ladhani, SN., Cordery, R., Mandal, S., et al.[2022]

The 4CMenB vaccine, primarily designed to protect against meningococcal infections, may also provide some level of protection against Neisseria gonorrhoeae, the bacteria responsible for gonorrhea, although more research is needed to confirm this.

Understanding the immune response to gonococcal infections is complex, as the mechanisms of protection against local infections (like gonorrhea) may differ from those against systemic infections (like meningitis), highlighting the need for further studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insight into Prevention of Neisseria Gonorrhoeae: A Short Review. La Fauci, V., Lo Giudice, D., Squeri, R., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6466174/

Effectiveness of a Group B Outer Membrane Vesicle ... In conclusion, the data suggests vaccination with MeNZB™ significantly reduced the rate of hospitalization from gonorrhea. This supports prior research ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04350138

NCT04350138 | Safety and Efficacy Study of ... The primary objective of the study is to demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25004852

Meningococcal vaccines show effectiveness in gonorrhoea ... The pooled analysis yielded a vaccine effectiveness (VE) of 38 % [95 % CI:22 %–50 %; I2 = 55 %]. Including only the 4CMenB vaccine, VE was 41 % ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2808945

Association of Group B Meningococcal Vaccine Receipt ... The OMV-based MBV was 47% (95% CI, 13%-68%) effective in preventing gonorrhea among recipients aged 18 to 29 years.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10175191/

Healthy vaccinee bias and MenB-FHbp vaccine ... Observational studies demonstrated 30–40% effectiveness of OMV meningococcal serogroup-B vaccines against gonorrhea. To explore whether healthy vaccinee bias ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04350138?term=NCT04350138%26rank=1

Safety and Efficacy Study of Meningococcal Group B ... gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 primary endpoints in the Per Protocol Population.