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
Study duration per participant is approximately 16 months
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Route of administration: Intramuscular
Route of administration: Intramuscular
Route of administration: Intramuscular
Route of administration: Intramuscular
Route of administration: Intramuscular
Route of administration: Intramuscular
Route of administration: Intramuscular
Research Centers of America-Site Number:8400010
Hollywood, Florida, United States
Brigham and Womens Hospital-Site Number:8400003
Boston, Massachusetts, United States
M3 Wake Research Inc-Site Number:8400006
Raleigh, North Carolina, United States
University of Washington Virology Research Clinic-Site Number:8400001
Seattle, Washington, United States
Number of participants with immediate adverse events
Unsolicited systemic adverse events occurring immediately after vaccination
Time frame: 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
Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
Time frame: Within 7 days after vaccination
Number of participants with unsolicited adverse events
An unsolicited adverse event is an event that does not fulfill the conditions prelisted in the Case Report Book in terms of diagnosis and/or onset post-vaccination
Time frame: Within 30 days after vaccination
Number of participants with medically-attended adverse events (MAAEs)
An MAAE is a new onset or a worsening of a condition that prompts the participant to seek unplanned medical advice at a physician's office or Emergency Department
Time frame: From Day 0 to Month 14
Number of participants with adverse events of special interest (AESIs)
AESIs are collected throughout the study
Time frame: From Day 0 to Month 14
Number of participants with serious adverse events (SAEs)
SAEs are collected throughout the study
Time frame: From Screening to Month 14
Number of participants with out-of-range biological test results
Out-of-range biological test results area assessed at Days 8 and 30 after each vaccination and 15 days prior to second vaccination in Part A and Days 8 and 30 after each vaccination in Part B
Time frame: From Day 8 to Day 30
Viral genital shedding rate
Relative change in HSV DNA detection frequency between swabs collected before the first vaccination and those collected after the second vaccination visit
Time frame: 60 days before first vaccination and 60 days after the second vaccination
Genital HSV recurrence
Proportion of participants free of genital HSV recurrence following the second vaccination
Time frame: 6 months following the second vaccination
Genital lesion rate
Total number of days that the participants who receive investigational product or placebo report genital herpes lesions following the second vaccination
Time frame: 6 months after the second vaccination
Genital HSV recurrence
Number of recurrences of genital HSV following the second vaccination in participants who receive investigational product or placebo. Recurrence is defined as the appearance of genital and perineal lesions (i.e., shingles, blisters, ulcers) in a previously asymptomatic participant. Regarding 2 separate episodes of recurrences, recurrence is defined as the presentation of a new lesion (or lesions) after a 1-day-minimum (≥ 24 hours) lesion-free period
Time frame: 60 days following the second vaccination
Viral genital shedding rate after the first and second vaccination
Relative change in HSV DNA detection frequency between swabs collected before the first vaccination visit and those collected 60 days after the first vaccination visit plus after the second vaccination visit in participants who receive investigational product or placebo
Time frame: 60 days before first vaccination, and 60 days after the first vaccination, plus 60 days after the second vaccination
Viral genital shedding rate after the first vaccination
Relative change in HSV DNA detection frequency between swabs collected before the first vaccination visit and those collected 60 days after the first vaccination visit in participants who receive investigational product or placebo
Time frame: 60 days before and 60 days after the first vaccination
Change in serum HSV 2-antibody levels
Change between pre-vaccination and post-first and second vaccinations
Time frame: Before and 30 days after the first and second vaccinations and 6 months after the second vaccination
Change in level of HSV 2-specific cellular immune responses
Change between pre-vaccination and post-first and second vaccinations
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Before and 8 days after the first and second vaccination and 6 months after the second vaccination