Clinical Trials Logo
  1. Home
  2. Genital Herpes
  3. NCT04222985

Safety and Efficacy of 4 Investigational HSV 2 Vaccines in Adults With Recurrent Genital Herpes Caused by HSV 2 — HSV15  

Genital Herpes Clinical Trial

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

Clinical Trial 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

Clinical Trial Description

Study duration per participant is approximately 16 months ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04222985
Study type Interventional
Source Sanofi
Contact
Status Terminated
Phase Phase 1
Start date February 18, 2020
Completion date May 19, 2021
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT06033261 - A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes Phase 1/Phase 2
Completed NCT00362297 - Randomized Trial to Evaluate Suppressive Effect of High-Dose Acyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 Phase 4
Completed NCT01132729 - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions N/A
Completed NCT01132716 - Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions N/A
Completed NCT03831165 - Melatonin Effects on Genital Herpes in Brazilian Women Phase 4
Terminated NCT01658826 - Safety and Efficacy Comparator Trial of a New Drug Against Genital Herpes Phase 2
Completed NCT00262106 - Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection Phase 3
Completed NCT01346475 - Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2 Phase 4
Completed NCT01390805 - Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis) N/A
Terminated NCT03146403 - Maintenance Dose Study of GEN-003 in Subjects With Genital Herpes Infection Phase 2
Completed NCT03080961 - The VIBLOK SAfety and perFormancE Trial N/A
Completed NCT00306787 - Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes Phase 3
Completed NCT00231049 - Trial Evaluating Safety, Tolerability and Immune Response of AG-707 Phase 1
Completed NCT00477334 - Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients Phase 4
Completed NCT00495573 - HSV-2 Shedding Resolution After Acyclovir Treatment N/A
Not yet recruiting NCT03595995 - A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 Phase 2
Completed NCT01281007 - Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes Phase 3
Completed NCT01112956 - Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2 N/A
Completed NCT00129818 - A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding Phase 4
Completed NCT00808405 - GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women N/A