Gonorrhea Clinical Trial
— BexKPKOfficial title:
Use of Bexsero Immunisation to Detect Cross Reactive Antigens and Anti-gonococcal Antibodies in Key Populations in Kenya
Verified date | April 2022 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 people aged 18-25 years. 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 vaccine (Bexsero®) licensed outside of Kenya against meningococcal B disease may also be effective against gonorrhoea due to genetic similarities between the two organisms causing the two diseases. The aim of this study is to generate data to develop a gonorrhoea vaccine, using an existing vaccine against meningococcal disease
Status | Completed |
Enrollment | 50 |
Est. completion date | February 28, 2022 |
Est. primary completion date | February 5, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: - 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 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). |
Country | Name | City | State |
---|---|---|---|
Kenya | KEMRI-Wellcome Trust Research Programme | Kilifi |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | KEMRI-Wellcome Trust Collaborative Research Program |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | humoral and T cell cross-reactive responses against Neisseria gonorrhoeae | Serum antigen- and OMV-specific IgG1, IgG2a, Ig3A and IgA titres will be determined.
T cell responses will be measured in two ways: Indirect responses: by determining the IgG1/IgG2 ratios after immunization. Direct responses: PBMCs will be isolated at enrolment, 2 weeks post second immunization and used for the detection of antigen-specific IFN secreting T cells. The induction of antibody will be measured by a standard endpoint ELISA assay using peptides covering recombinant protein antigens, purified antigens, and defined OMVs. After the final immunization, PBMCs will be collected for isolation of antigen-specific memory B cells, aiming to generate human monoclonal antibodies (mAbs) against key vaccine candidates. |
approximately 2 weeks following completed vaccination (2 doses) |
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