Stopped: business reasons-Phase 2/Part B not conducted. Study terminated after last patient enrolled in Phase 1/Part A
The primary objectives of the study are: * To describe the safety profile of different investigational vaccine regimens against herpes simplex virus type 2 (HSV-2). * To evaluate the efficacy of the investigational vaccine regimens with respect to: * the frequency of herpes simplex virus (HSV) deoxyribonucleic acid (DNA) detection in the genital area (shedding rate) following a 2 dose vaccine schedule * the proportion of participants free of HSV genital recurrence at 6 months after the 2-dose vaccine schedule The secondary objectives of the study are: * To describe the impact of each of the investigational vaccine regimens in terms of total number of days with genital lesion up to 6 months after vaccination 2 and number of recurrences 60 days after the second vaccination compared with the placebo group * To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit plus 60 days following the second vaccination visit compared with the placebo group * To describe the efficacy of each of the investigational vaccine regimens with respect to the frequency of HSV DNA detection in the genital area (shedding rate) 60 days following the first vaccination visit compared with the placebo group
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Number of participants with immediate adverse events
Timeframe: Within 4 hours (participants in Part A) or 30 minutes (participants in Part B) after vaccination
Number of participants with solicited injection site and systemic reactions
Timeframe: Within 7 days after vaccination
Number of participants with unsolicited adverse events
Timeframe: Within 30 days after vaccination
Number of participants with medically-attended adverse events (MAAEs)
Timeframe: From Day 0 to Month 14
Number of participants with adverse events of special interest (AESIs)
Timeframe: From Day 0 to Month 14
Number of participants with serious adverse events (SAEs)
Timeframe: From Screening to Month 14
Number of participants with out-of-range biological test results
Timeframe: From Day 8 to Day 30
Viral genital shedding rate
Timeframe: 60 days before first vaccination and 60 days after the second vaccination
Genital HSV recurrence
Timeframe: 6 months following the second vaccination