Gonococcal Vaccine Study in Key Populations in Kenya

NCT04297436 | Completed

• 2 other identifiers: CSC 182OXTREC16-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Gonorrhea

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Bexsero

OTHER

Each participant is compared to baseline (before vaccination)

Biological: 4CMenB (Bexsero®) vaccine

Interventions

4CMenB (Bexsero®) vaccine 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.

Bexsero

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Oxford: lead
• KEMRI-Wellcome Trust Collaborative Research Program: collaborator

Study Sites (1)

KEMRI-Wellcome Trust Research Programme

Kilifi, Kenya

Location

MeSH Terms

Conditions

Gonorrhea

Interventions

4CMenB vaccine; Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Eduard Sanders, MD, PhD

  University of Oxford & KEMRI-Wellcome Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To 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)

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 5, 2020
• Study Start: May 31, 2021
• Primary Completion: February 5, 2022
• Study Completion: February 28, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: during study and storage for 10 years
• Access Criteria: Direct access will be granted to authorised representatives from the Sponsor, host institution and the regulatory authorities to permit trial-related monitoring, audits and inspections.

Locations

KE (1)