Gonococcal vaccine study in key populations in Kenya
- Conditions
- gonorrhoea
- Registration Number
- PACTR202009774604118
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 50
Minimum Age: 18 Years
Maximum Age: 25 Years
Sex: All
Gender Based: No
Accepts Healthy Volunteers: Yes
Criteria: Inclusion Criteria:
• Healthy male and female as assessed by a medical history, physical exam,
and laboratory tests.
• HIV-positive participants who are adherent to ART and virally suppressed (viral load <200 copies per ml) are considered healthy .
• At least 18 years of age on the day of screening and will not reach 26th birthday on the day of the second vaccination (approximately 6 weeks after enrolment)
• Willing and able to give informed consent for participation in the trial before
any study-related procedures are performed.
• Willing to donate blood samples for immunogenicity assessments.
Exclusion Criteria:
• Any clinically significant acute or chronic medical condition that is considered progressive that, in the opinion of the Principal Investigator or designee, makes the volunteer unsuitable for participation in the trial
• Pregnancy
• Participation in another clinical trial (i.e. investigational HIV vaccine candidate), within the previous 3 months or expected participation during the study
• Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions).
• History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulty, angioedema).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero) elicits humoral and T cell cross-reactive responses against Ng.<br>
- Secondary Outcome Measures
Name Time Method To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero) differs between HIV negative and positive participants.