Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2
- Conditions
- Genital Herpes
- Interventions
- Biological: HSV 2 Formulation 3Biological: HSV 2 Formulation 1Biological: HSV 2 Formulation 2Biological: HSV 2 Formulation 6Biological: HSV 2 Formulation 4Biological: HSV 2 Formulation 5Biological: Sodium Chloride 0.9%
- Registration Number
- NCT04222985
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
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
- Detailed Description
Study duration per participant is approximately 16 months
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A - Group 4 HSV 2 Formulation 3 HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2 Part A - Group 4 HSV 2 Formulation 4 HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2 Part A - Group 4 Sodium Chloride 0.9% HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2 Part A - Group 5 HSV 2 Formulation 3 HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2. Part B (Stage 2) - Group 1 HSV 2 Formulation 1 HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part A - Group 2 Sodium Chloride 0.9% HSV 2 formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part A - Group 6 Sodium Chloride 0.9% Sodium chloride 0.9% (in both arms) at Month 0 and Month 2 Part B (Stage 2) - Group 4 HSV 2 Formulation 3 HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2 Part B (Stage 2) - Group 4 HSV 2 Formulation 4 HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2 Part A - Group 2 HSV 2 Formulation 2 HSV 2 formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part A - Group 5 HSV 2 Formulation 5 HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2. Part B (Stage 1) - Group 1 Sodium Chloride 0.9% HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part A - Group 1 HSV 2 Formulation 1 HSV 2 formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part A - Group 1 Sodium Chloride 0.9% HSV 2 formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 1) - Group 3 HSV 2 Formulation 3 HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 1) - Group 4 HSV 2 Formulation 3 HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2 Part B (Stage 1) - Group 4 HSV 2 Formulation 4 HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2 Part B (Stage 1) - Group 5 HSV 2 Formulation 5 HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2 Part B (Stage 1) - Group 7 Sodium Chloride 0.9% HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part A - Group 3 HSV 2 Formulation 3 HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part A - Group 3 Sodium Chloride 0.9% HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 1) - Group 2 HSV 2 Formulation 2 HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 2) - Group 2 Sodium Chloride 0.9% HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 2) - Group 3 Sodium Chloride 0.9% HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 2) - Group 6 Sodium Chloride 0.9% Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2 Part B (Stage 1) - Group 1 HSV 2 Formulation 1 HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 1) - Group 4 Sodium Chloride 0.9% HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2 Part B (Stage 1) - Group 6 Sodium Chloride 0.9% Sodium Chloride 0.9% (in both arms) at Month 0 and Month 2 Part B (Stage 1) - Group 7 HSV 2 Formulation 6 HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 2) - Group 3 HSV 2 Formulation 3 HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 2) - Group 4 Sodium Chloride 0.9% HSV 2 Formulation 4 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0, then HSV 2 Formulation 3 administered with concomitantly with 0.9% sodium chloride in the opposite arm at Month 2 Part B (Stage 2) - Group 7 Sodium Chloride 0.9% HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 1) - Group 2 Sodium Chloride 0.9% HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 2) - Group 1 Sodium Chloride 0.9% HSV 2 Formulation 1 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 2) - Group 7 HSV 2 Formulation 6 HSV 2 Formulation 6 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 1) - Group 3 Sodium Chloride 0.9% HSV 2 Formulation 3 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 1) - Group 5 HSV 2 Formulation 3 HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2 Part B (Stage 2) - Group 2 HSV 2 Formulation 2 HSV 2 Formulation 2 administered concomitantly with 0.9% sodium chloride in the opposite arm at Month 0 and Month 2 Part B (Stage 2) - Group 5 HSV 2 Formulation 3 HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2 Part B (Stage 2) - Group 5 HSV 2 Formulation 5 HSV 2 Formulation 5 administered in one arm and Formulation 3 in the opposite arm, at Month 0 and Month 2
- Primary Outcome Measures
Name Time Method Number of participants with unsolicited adverse events Within 30 days after vaccination 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
Number of participants with adverse events of special interest (AESIs) From Day 0 to Month 14 AESIs are collected throughout the study
Number of participants with medically-attended adverse events (MAAEs) From Day 0 to Month 14 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
Number of participants with serious adverse events (SAEs) From Screening to Month 14 SAEs are collected throughout the study
Genital HSV recurrence 6 months following the second vaccination Proportion of participants free of genital HSV recurrence following the second vaccination
Number of participants with immediate adverse events Within 4 hours (participants in Part A) or 30 minutes (participants in Part B) after vaccination Unsolicited systemic adverse events occurring immediately after vaccination
Number of participants with solicited injection site and systemic reactions Within 7 days after vaccination Injection site reactions: injection site pain, erythema, and swelling. Systemic reactions: fever, headache, malaise, myalgia, arthralgia and chills
Number of participants with out-of-range biological test results From Day 8 to Day 30 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
Viral genital shedding rate 60 days before first vaccination and 60 days after the second vaccination Relative change in HSV DNA detection frequency between swabs collected before the first vaccination and those collected after the second vaccination visit
- Secondary Outcome Measures
Name Time Method Genital HSV recurrence 60 days following the second vaccination 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
Change in serum HSV 2-antibody levels Before and 30 days after the first and second vaccinations and 6 months after the second vaccination Change between pre-vaccination and post-first and second vaccinations
Viral genital shedding rate after the first and second vaccination 60 days before first vaccination, and 60 days after the first vaccination, plus 60 days after the 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
Change in level of HSV 2-specific cellular immune responses Before and 8 days after the first and second vaccination and 6 months after the second vaccination Change between pre-vaccination and post-first and second vaccinations
Genital lesion rate 6 months after the second vaccination Total number of days that the participants who receive investigational product or placebo report genital herpes lesions following the second vaccination
Viral genital shedding rate after the first vaccination 60 days before and 60 days 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
Trial Locations
- Locations (4)
M3 Wake Research Inc-Site Number:8400006
🇺🇸Raleigh, North Carolina, United States
Brigham and Womens Hospital-Site Number:8400003
🇺🇸Boston, Massachusetts, United States
Research Centers of America-Site Number:8400010
🇺🇸Hollywood, Florida, United States
University of Washington Virology Research Clinic-Site Number:8400001
🇺🇸Seattle, Washington, United States