BIYELA - Bexsero Immunisation in Young Women in Africa

Launched by UNIVERSITY OF WASHINGTON · Jun 4, 2024

Keywords

ClinConnect Summary

The BIYELA trial is studying a vaccine called Bexsero to see if it can help protect young women in Africa from gonorrhea, a common sexually transmitted infection. This trial will involve two groups of women: one group will receive the vaccine, and the other group will receive a placebo (a shot that doesn’t contain the vaccine) at the start of the study and again two months later. The goal is to learn more about how this vaccine might work not only against meningococcal disease but also against gonorrhea.

To participate, women need to be between 18 and 45 years old, healthy, and at risk for gonorrhea based on their sexual history. They must also agree not to get pregnant during the study and take a pregnancy test before each vaccination. Participants will receive health check-ups and guidance throughout the trial. It’s important for potential participants to understand that they should not have received certain medications or vaccines recently. This trial is currently recruiting, so if you or someone you know meets these criteria and is interested, it could be an opportunity to contribute to important health research.

Gender

FEMALE

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