Vaccination to prevent gonorrhea in young women in Africa

A Phase 3 Randomized, Observer-Blind, Placebo-Controlled Study to Assess Efficacy of Meningococcal Group B (rMenB+OMV NZ (Bexsero)) in Preventing Gonococcal Infection Among South African Cis-Gender Women

This study is testing if the 4CMenB vaccine can help prevent gonorrhea in young women in Africa who are at risk for the infection.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1100 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: University of Washington (Academic / other)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 5 sites (Cape Town and 4 other locations)
• Trial ID: NCT06446752 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the 4CMenB vaccine in preventing gonorrhea among young women in Africa. It is a randomized, two-arm study comparing two doses of the vaccine against a placebo, aimed at providing proof-of-concept for dual prevention of meningococcal B and gonococcal infections. The study focuses on young women aged 18-45 who are at risk for gonorrhea, particularly those with a history of sexually transmitted infections. The trial seeks to address the high incidence of gonorrhea and its long-term health consequences in low- and middle-income countries.

Who should consider this trial

Good fit: Ideal candidates for this study are young women aged 18-45 who are sexually active and at risk for gonorrhea.

Not a fit: Patients who are not sexually active or those who are not within the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new preventive measure against gonorrhea, significantly improving sexual and reproductive health outcomes for young women.

How similar studies have performed: While there have been studies on STI prevention, this specific approach using the 4CMenB vaccine for gonorrhea prevention is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Individuals born female aged 18-45 years of age inclusive on the day of screening
* In good health as determined by past medical history, medication use, and targeted physical examination,

  1. If not living with HIV, negative HIV test conducted at screening
  2. If living with HIV, on an antiretroviral regimen for ≥3 months, with an undetectable HIV RNA of \<200 copies/ml and/or a CD4 count \>300 cells/cmm within 12 months of screening
* If of reproductive potential,

  1. Willing to not become pregnant during vaccination period and
  2. Have a negative pregnancy test prior to each vaccination and
  3. Willing to use a reliable method of contraception until month 3 (i.e., after the second vaccination visit)
  4. Not breastfeeding
* Sexually active in the past 3 months, defined as vaginal or anal sex
* At risk for gonorrhea based on sexual behaviour characteristics including

  1. Previous PrEP use in the past 12 months, or
  2. Past history of STIs in the past 12 months, or
  3. 2 or more partners in the past 12 months
* Has provided signed informed consent, and is willing and likely to comply with the trial procedures and follow-up visit requirements
* Has a negative gonorrhea and chlamydia nucleic acid amplification test (NAAT) in the 14 days prior to the Enrollment Visit

Exclusion Criteria:

* Contra-indications to Bexsero
* Previous receipt of a Meningococcal Group B vaccine
* Receipt of antibiotics active against N. gonorrhoeae in the 14 days prior to the Enrollment Visit, including oral or parenteral antibiotics\*

  * Participants with NG and/or CT detected at screening may re-screen after receiving appropriate antibiotic treatment
* Planned long-term (\> 4 weeks) antibiotic use for prophylaxis or treatment for acne or other bacterial condition(s)
* Use or planned use of a live vaccine within +/- 30 days, an inactive vaccine within +/- 14 days, or an influenza vaccine within +/- 7 days from receipt of study product. Authorized or approved, inactivated COVID-19 vaccines may be given more than 7 days +/- receipt of study product for all study participants
* Use of any investigational drug or vaccine within 30 days prior to enrollment, or planned/anticipated use during study participation
* Currently receiving immunosuppressive agent or systemic corticosteroids (dose \>5 mg/day of prednisone) for \>14 consecutive days within 90 days prior to enrollment. Topical or inhaled steroids are allowed. Topical steroids cannot be applied to study product injection site
* Has received antineoplastic (chemotherapy) or radiotherapy within 90 days prior to enrollment
* Has received immunoglobulins and/or any blood products within 180 days prior to enrollment
* Progressive, unstable, or uncontrolled disease including but not limited to cardiac, hepatic, renal, immunological, neurological or psychiatric conditions
* Has a condition which in the opinion of the investigator is not suitable for intramuscular vaccination, blood draws, or participation in the trial
* Pregnant or breastfeeding at enrollment

Where this trial is running

Cape Town and 4 other locations

• Desmond Tutu Health Foundation - Emavundleni Research Centre — Cape Town, South Africa (Recruiting)
• Desmond Tutu Health Foundation - Masiphumulele Site — Cape Town, South Africa (Recruiting)
• Khayelitsha Vuka Research Clinic — Cape Town, South Africa (Active_not_recruiting)
• Wits RHI Ward 21 Clinical Research Site — Johannesburg, South Africa (Recruiting)
• Center for Community Based Research (CCBR) — Pietermaritzburg, South Africa (Active_not_recruiting)

Study contacts

• Principal investigator: Connie Celum, MD, MPH — University of Washington
• Study coordinator: Caitlin Scoville

Conditions Gonorrhea; Gonorrhea of Pharynx; Gonorrhea of Anus; Gonorrhea of Cervix; sexually transmitted infections; STI