DMID 19-0004/HPTN 107
A Phase II randomized, observer-blind, placebo-controlled study, to assess efficacy of meningococcal Group B vaccine rMenB+OMV NZ (Bexsero) in preventing gonococcal infection.
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Protocol Status
Enrolling
Study Purpose
This is a Phase II, randomized, observer-blind, placebo-controlled, multi-site trial of the FDA licensed rMenB+OMV NZ vaccine, Bexsero. The targeted study population is men and women 18-50 years of age who are disproportionately vulnerable to N. gonorrhoeae infection. Approximately 2,200 participants are expected to be enrolled to achieve at least 202 evaluable participants. Data will be collected in an observer-blind manner. Study product recipients and study staff responsible for the evaluation of any study endpoint will be unaware of whether Bexsero or placebo were administered. The duration of the study for participants who are enrolled and randomized will be approximately 16 months. Study participation is expected to be completed in approximately 36 months. The primary objective of the study is to demonstrate efficacy of Bexsero in prevention of urogenital and/or anorectal gonococcal infection.
Study Design
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Population
18 Years to 50 Years (Adult )
Study Size
2200 participants
Study Duration
Treatment Regime
Biological: Meningococcal Group B Vaccine
A combination vaccine consisting of rMenB and OMV NZ.
Other: Placebo
150mM sodium chloride (0.9% saline solution).
Primary Objectives
Number of participants diagnosed with urogenital or anorectal gonococcal infection post second vaccination [Time Frame: Day 91 to Day 451]
Confirmed by Nucleic Acid Amplification Test (NAAT).
Secondary Objectives
• Number of participants diagnosed with urogenital, anorectal, or pharyngeal gonococcal infection post second vaccination [Time Frame: Day 91 to Day 451]
• Confirmed by Nucleic Acid Amplification Test (NAAT).
• Proportion of participants that experience at least one adverse event (AE) that results in withdrawal from study [Time Frame: Day 1 to Day 451]
• Disease or medical condition, or new clinical finding(s) for which continued participation, in the opinion of the investigator might compromise the safety of the participant, interfere with the participant's successful completion of this study, or interfere with the evaluation of study endpoints.
• Proportion of participants that experience at least one adverse event of special interest (AESI) [Time Frame: Day 1 to Day 451]
• Adverse Event of Special Interest (AESI) are specific to the protocol: Arthritis, Potential immune-mediated diseases (pIMD).
• Proportion of participants that experience at least one serious adverse event (SAE) [Time Frame: Day 1 to Day 451]
• Proportion of participants with at least one medically attended adverse event (MAAE) [Time Frame: Day 1 to Day 451]