Status:
COMPLETED
Gonococcal Vaccine Study in Key Populations in Kenya
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
KEMRI-Wellcome Trust Collaborative Research Program
Conditions:
Gonorrhea
Eligibility:
All Genders
18-25 years
Phase:
NA
Brief Summary
Gonorrhoea is a sexually transmitted infection that can infect both men and women. It can cause infections in the genitals, rectum, and throat. It is a very common infection, especially among young pe...
Detailed Description
Meningococcal disease and gonorrhoea are caused by bacteria that are closely related but cause different diseases that are spread in different ways. New evidence suggests that the Meningococcal B vacc...
Eligibility Criteria
Inclusion
- Healthy male and female as assessed by a medical history, physical exam, and laboratory tests (specified in study operations manual).
- 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
- 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).
Key Trial Info
Start Date :
May 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04297436
Start Date
May 31 2021
End Date
February 28 2022
Last Update
April 14 2022
Active Locations (1)
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1
KEMRI-Wellcome Trust Research Programme
Kilifi, Kenya