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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
52
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.
The Hope Clinic of Emory University
Decatur, Georgia, United States
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Rectal mucosal IgG concentrations (geometric mean titers, GMT) against GC OMV antigen Ng1291 by ELISA at Day 1, 29, 43, 57, and 181 in each treatment group
Time frame: Day 1 through Day 181
Rectal Mucosal IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Rectal mucosal IgG concentrations (geometric mean titers, GMT) against GC OMV antigen CNG20 by ELISA at Day 1, 29, 43, 57, and 181 in each treatment group
Time frame: Day 1 through day 181
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen Ng1291
Serum IgG concentrations (geometric mean titers, GMT) against GC OMV antigen Ng1291 at Day 1, 29, 43, 57, and 181 in each treatment group
Time frame: Day 1 through Day 181
Serum IgG Concentrations (Geometric Mean Titers [GMT]) Against N. Gonorrhoeae Outer Membrane Vesicle (OMV) Antigen CNG20
Serum IgG concentrations (geometric mean titers, GMT) against GC OMV antigen CNG20 at Day 1, 29, 43, 57, and 181 in each treatment group
Time frame: Day 1 through day 181
The Reactogenicity of 4CMenB in Healthy Adult Participants
Frequency and severity of any adverse events (AE) related to 4CMenB immunization
Time frame: Day 1 through Day 181
Frequency of Serious Adverse Events (SAE)
Frequency of SAEs through the end of the study.
Time frame: Day 1 through Day 181
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