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A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years

NCT04762511 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-06-28

No results posted yet for this study

Summary

The purpose of this first-time-in-human (FTiH) study is to assess the reactogenicity, safety and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine, when administered intramuscularly (IM) on a 0, 2-month schedule to healthy participants aged 18-40 years.

Conditions

  • Herpes Simplex

Interventions

BIOLOGICAL

Lower dose formulation of HSV vaccine (GSK4108771A)

2 doses of the lower dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

BIOLOGICAL

Low dose formulation of HSV vaccine (GSK4108771A)

2 doses of the low dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

BIOLOGICAL

Medium dose formulation of HSV vaccine (GSK4108771A)

2 doses of the medium dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

BIOLOGICAL

High dose formulation of HSV vaccine (GSK4108771A)

2 doses of the high dose formulation of the HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

DRUG

Placebo (saline)

2 doses of placebo (saline) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2021-05-26
Completion
2021-05-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04762511 on ClinicalTrials.gov