Meningococcal Group B Vaccine for Gonorrhea

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

2606 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 primary endpoints in the Per Protocol Population. Data will be collected in an observer-blind manner. Study product recipients and study staff responsible for the evaluation of any study endpoint will be unaware of whether Bexsero or placebo were administered. The duration of the study for participants who are enrolled and randomized will be approximately 16 months. Study participation is expected to be completed in approximately 36 months. The primary objective of the study is to demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection.

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.

What data supports the effectiveness of the treatment Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) for gonorrhea?

Research suggests that the Meningococcal Group B Vaccine, which includes the OMV component, may offer moderate protection against gonorrhea, with studies showing a 30% to 40% effectiveness in reducing gonorrhea rates. This is likely due to the close relationship between the bacteria causing meningococcal disease and gonorrhea, allowing the vaccine to trigger an immune response that helps protect against both. ^{1 2 3 4 5}

Is the Meningococcal Group B Vaccine (Bexsero) safe for humans?

The Meningococcal Group B Vaccine (Bexsero) has been generally well-tolerated in studies, with most side effects being mild and temporary, such as low-grade fever. Serious adverse events were rare and only a few were possibly related to the vaccine. ^{6 7 8 9 10}

How does the Meningococcal Group B Vaccine (Bexsero) differ from other treatments for gonorrhea?

The Meningococcal Group B Vaccine (Bexsero) is unique because it was originally developed to protect against meningococcal disease but has shown potential to also protect against gonorrhea, a condition with no existing vaccine. This vaccine contains outer membrane vesicles (OMV) and recombinant proteins, which may provide cross-protection against the bacteria causing gonorrhea. ^{1 3 4 7 11}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of meningococcal group B OMV vaccines, beyond their brief. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Healthy Vaccinee Bias and MenB-FHbp Vaccine Effectiveness Against Gonorrhea. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

The Serogroup B Meningococcal Vaccine Bexsero Elicits Antibodies to Neisseria gonorrhoeae. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. [2010]

5. England 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(®)). [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

[Economic evaluation of the introduction of 4CMenB (Bexsero®) in the national vaccine schedule in Spain]. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in infants (II). [2018]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Safety surveillance of meningococcal group B vaccine (Bexsero®), Vaccine Adverse Event Reporting System, 2015-2018. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Insight into Prevention of Neisseria Gonorrhoeae: A Short Review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Meningococcal Group B Vaccine (4CMenB) in Children. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Routine vaccination against MenB: considerations for implementation. [2021]