Gonococcal Vaccine Study in Key Populations in Kenya
Condition: Gonorrhea
MeSH terms: Gonorrhea
Study type: Interventional

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.
    

Intervention name(s): 4CMenB (Bexsero®) vaccine
Intervention type(s): Biological
Intervention description(s): 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 model: Single Group Assignment
Intervention model description: 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)
Masking: None (Open Label)
Primary purpose: Basic Science