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

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

Conditions

• Genital Herpes

Interventions

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

Sponsors & Collaborators

• Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

  collaborator INDUSTRY

• Sanofi Pasteur, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Clinical Sciences & Operations · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-02-18

Primary Completion

2021-05-19

Completion

2021-05-19

FDA Drug

Yes

Countries

• United States

Study Locations