NCT04222985

Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2

Safety and Efficacy of 4 Investigational HSV 2 Vaccines Administered by Intramuscular Route in Adults With Recurrent Genital Herpes Caused by HSV 2

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Genital Herpes

Interventions

Type	Name	Description
BIOLOGICAL	HSV 2 Formulation 1	Route of administration: Intramuscular
BIOLOGICAL	HSV 2 Formulation 2	Route of administration: Intramuscular
BIOLOGICAL	HSV 2 Formulation 3	Route of administration: Intramuscular
BIOLOGICAL	HSV 2 Formulation 4	Route of administration: Intramuscular
BIOLOGICAL	HSV 2 Formulation 5	Route of administration: Intramuscular
BIOLOGICAL	HSV 2 Formulation 6	Route of administration: Intramuscular
BIOLOGICAL	Sodium Chloride 0.9%	Route of administration: Intramuscular

Timeline

• Start date: 2020-02-18
• Primary completion: 2021-05-19
• Completion: 2021-05-19
• First posted: 2020-01-10
• Last updated: 2022-10-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study