Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults

An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without 3D MPL

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00698893

Enrollment

Registered

2008-06-17

Start date

1992-05-01

Completion date

1992-07-01

Last updated

2017-06-02

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

Conditions

Herpes Simplex

Keywords

Herpes simplex, Herpes simplex candidate (gD) vaccine

Brief summary

The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.

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 (gD) vaccine GSK208141

Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

Inclusion criteria

* Between 18 and 40 years of age * Seropositive for antibodies against HSV * Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study. * Good physical condition as established by physical examination and history taking at the time of entry

Exclusion criteria

* Any abnormal laboratory value among the tests performed at screening. * History of persistent hepatic, renal, cardiac or respiratory diseases * Clinical signs of acute illness at the time of entry into the study. * Previous history of asthma or hypersensitivity to drugs. * Seropositive for antibodies against the human immunodeficiency virus * Pregnancy and lactation. * Treatment with corticosteroids or immunomodulating drugs. * Simultaneous participation in another clinical trial. * Administration of any other vaccine or immunoglobulins during the study period

Design outcomes

Primary

Measure	Time frame
To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms	Throughout the study
Measurement of haematology/biochemical parameters on blood samples	Throughout the study
Vaccine reactogenicity by soliciting of local and general signs/symptoms	On the day of vaccination and the subsequent 7 days
Vaccine immunogenicity by 6 measurements of anti-HSV antibodies	From day 0 to day 45 following vaccination

Outcome results

None listed

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