Completed

Study in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant

What is being tested

Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant

+ Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant

Biological

Who is being recruted

DNA Virus Infections+6

+ Herpes Simplex

+ Herpesviridae Infections

From 18 to 40 Years

+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 2

Interventional

Study Start: September 1992

See protocol details

Summary

Principal SponsorGlaxoSmithKline

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1992

Actual date on which the first participant was enrolled.

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Official TitleStudy in Healthy HSV Positive and HSV Negative Adults to Evaluate the Immunogenicity, Reactogenicity and Safety of GSK Biologicals' Herpes Simplex (gD) Candidate Vaccine With or Without Adjuvant

NCT00697567

Principal SponsorGlaxoSmithKline

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DNA Virus InfectionsHerpes SimplexHerpesviridae InfectionsInfectionsSkin DiseasesSkin Diseases, InfectiousVirus DiseasesSkin Diseases, ViralSkin and Connective Tissue Diseases

Criteria

4 inclusion criteria required to participate

Between 18 and 40 years of age

Written informed consent

Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.

Good clinical condition as evidenced by history taking and physical examination

9 exclusion criteria prevent from participating

History of persistent hepatic, renal, cardiac or respiratory diseases.

Clinical signs of acute illness at the time of entry into the study.

Seropositive for antibodies against the human immunodeficiency virus (HIV).

Pregnancy, lactation.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

HSV seropositive subjects

Group II

Experimental

HSV seronegative subjects

Group III

Experimental

HSV seropositive subjects

Group IV

Experimental

HSV seronegative subjects

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

GSK Clinical Trials Call Center

Ghent, BelgiumOpen GSK Clinical Trials Call Center in Google Maps

CompletedOne Study Center