NCT04762511

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

A Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety and Immune Response of an HSV Vaccine in Healthy Participants Aged 18-40 Years

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-03-02
• Primary completion: 2021-05-26
• Completion: 2021-05-26
• First posted: 2021-02-21
• Last updated: 2021-06-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study