Gonococcal Vaccine Study in Key Populations in Kenya

NCT ID: NCT04297436

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2022-02-28

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 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

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 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.

Conditions

Gonorrhea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Bexsero

Each participant is compared to baseline (before vaccination)

Group Type: OTHER

4CMenB (Bexsero®) vaccine

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KEMRI-Wellcome Trust Collaborative Research Program

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eduard Sanders, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford & KEMRI-Wellcome Trust

Locations

KEMRI-Wellcome Trust Research Programme

Kilifi, , Kenya

Countries

Kenya

Other Identifiers

OXTREC16-20

Identifier Type: OTHER

Identifier Source: secondary_id

CSC 182

Identifier Type: -

Identifier Source: org_study_id