Mucosal Immunity Against Neisseria Gonorrhoeae After 4CMenB Vaccination
Condition: Gonorrhoea
MeSH terms: Gonorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal
      immunogenicity of the multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero
      (R)) (group 1, 40 subjects) against Neisseria gonorrhoeae, using a placebo vaccine (normal
      saline) as a comparator (group 2, 10 subjects). There will be approximately 50 participants,
      ages 18-49, both male and non-pregnant female subjects, enrolled at 1 site in the US. The
      goal will be to ensure adequate representation of subjects by sex in both treatment groups.
      The enrollment will be stratified by both sex and treatment arm. During enrollment of the
      "biopsy cohort" male and non-pregnant female subjects will be randomized 4:1 to either 4CMenB
      or placebo, up to a maximum of 10 male and 10 non-pregnant female subjects. Group 1
      (approximate N=40) will receive two doses of 4CMenB on Day 1 and Day 29. Group 2 (approximate
      N=10) will receive two placebo injections on Day 1 and Day 29. Both groups will receive a
      single-dose prefilled syringe that is administered intramuscularly (0.5-mililiter each). The
      duration of each subject's participation is approximately 8 months, from recruitment through
      the last study visit, and the length of the study is estimated for 14 months. The primary
      objective is to characterize the rectal mucosal Immunoglobulin G IgG antibody response to
      Neisseria gonorrhoeae (GC) elicited by the 4CMenB vaccine as compared with the placebo
      vaccine (normal saline) in healthy adult subjects.
    

Detailed description: 
      This is a Phase 2 mechanistic clinical trial to assess the systemic and mucosal
      immunogenicity of the multicomponent meningococcal serogroup B vaccine (4CMenB or Bexsero
      (R)) (group 1, 40 subjects) against Neisseria gonorrhoeae, using a placebo vaccine (normal
      saline) as a comparator (group 2, 10 subjects). There will be approximately 50 participants,
      ages 18-49, both male and non-pregnant female subjects, enrolled at 1 site in the US. The
      goal will be to ensure adequate representation of subjects by sex in both treatment groups.
      The enrollment will be stratified by both sex and treatment arm. A subset of subjects in each
      treatment group (N=16 in Group 1, N=4 in Group 2) will undergo rectal mucosal biopsy at two
      time points (baseline and following the second vaccination) for assessment of tissue
      Neisseria gonorrhoeae (GC) specific cellular responses. During enrollment of the "biopsy
      cohort" male and non-pregnant female subjects will be randomized 4:1 to either 4CMenB or
      placebo, up to a maximum of 10 male and 10 non-pregnant female subjects. All subjects will
      undergo sampling of mucosal secretions for testing for antibodies against Neisseria
      gonorrhoeae (GC). Male subjects will undergo oropharyngeal and rectal mucosal sampling, and
      female subjects will undergo oropharyngeal, vaginal and rectal mucosal sampling. Group 1
      (approximate N=40) will receive two doses of 4CMenB on Day 1 and Day 29. Group 2 (approximate
      N=10) will receive two placebo injections on Day 1 and Day 29. Both groups will receive a
      single-dose prefilled syringe that is administered intramuscularly (0.5-mililter each). The
      duration of each subject's participation is approximately 8 months, from recruitment through
      the last study visit, and the length of the study is estimated for 14 months. The primary
      objective is to characterize the rectal mucosal Immunoglobulin G (IgG) antibody response to
      Neisseria gonorrhoeae (GC) elicited by the 4CMenB vaccine as compared with the placebo
      vaccine (normal saline) in healthy adult subjects. The secondary objectives are: 1) To
      characterize the serum IgG antibody response to Neisseria gonorrhoeae (GC) elicited by the
      4CMenB vaccine as compared with the placebo vaccine in healthy adult subjects, 2) To assess
      the safety and reactogenicity of 4CMenB in healthy adult subjects.
    

Intervention name(s): Meningococcal Group B Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.; 0.9% Sodium Chloride, USP injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: 4CMenB; Gonorrhea; Meningococcal Group B Vaccine; Meningococcal Immunization; Mucosal Immune Response; Neisseria gonorrhoeae