Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00697567

Enrollment

Registered

2008-06-16

Start date

1992-09-30

Completion date

1997-12-31

Last updated

2008-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis Herpes Simplex

Keywords

Herpes simplex, Herpes simplex vaccine

Brief summary

The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.

Detailed description

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

Interventions

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

Intramuscular injection, 3 doses

BIOLOGICALHerpes simplex candidate vaccine GSK208141- MPL-containing adjuvant

Intramuscular injection, 3 doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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. * Treatment with corticosteroids or immunomodulating drugs. * Simultaneous participation in another clinical trial. * Any previous history of allergy. * Any concomitant vaccination or administration of immunoglobulin during the study period. * Any abnormal laboratory value among the tests performed at screening

Design outcomes

Primary

Measure	Time frame
To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers	Days 0, 30, 60, 180 and 365 after vaccination
To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers	Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026