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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04297436
Other study ID # CSC 182
Secondary ID OXTREC16-20
Status Completed
Phase N/A
First received
Last updated
Start date May 31, 2021
Est. completion date February 28, 2022

Study information

Verified date April 2022
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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


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 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. Investigators will conduct a clinical trial of the Meningococcal B vaccine (Bexsero®) in approximately 50 male and female participants aged 18-25 years who are in follow up in KEMRI cohorts (including HIV-uninfected and infected individuals) at the KEMRI clinic in Mtwapa. This is not an efficacy trial. Instead, investigators will assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero®) elicits humoral and T cell cross-reactive responses against Neisseria gonorrhoeae (Ng). Participants will make six study visits, including a screening visit, an enrolment visit and 4 follow up visits. InvestigatorsF will offer vaccination with the Meningococcal B vaccine (Bexsero®) vaccine at the enrolment visit and approximately 2 months later. Investigators will collect a 20ml blood sample at enrolment, and following the first vaccination, and a 70ml blood sample following the second vaccination. At study completion (month 6), investigators will collect a 4ml blood sample. Investigators will collect a throat swab, a urine sample (for men), vaginal swab, and an anal swab at the enrolment, month 3 and month 6 visit to test for Chlamydiae and Gonorrhoea infection. Total study participation for participants is 6 months. Upon study completion, participants will continue to receive research care at the KEMRI clinic in Mtwapa.


Recruitment information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
4CMenB (Bexsero®) vaccine
Tthe 4CMenB vaccine (Bexsero®) contains the MeNZB OMV component plus three recombinant antigens (NadA, fHBP-GNA2091, and NHBA-GNA1030. The 4CMenB vaccine (Bexsero®) induces antibodies in humans that recognise gonococcal proteins.

Locations

Country Name City State
Kenya KEMRI-Wellcome Trust Research Programme Kilifi

Sponsors (2)

Lead Sponsor Collaborator
University of Oxford KEMRI-Wellcome Trust Collaborative Research Program

Country where clinical trial is conducted

Kenya, 

Outcome

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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