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

Phase 2

Completed

• Conditions: Prophylaxis Herpes Simplex
• Interventions: Biological: Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant; Biological: Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant

• Registration Number: NCT00697567
• Lead Sponsor: GlaxoSmithKline

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

Study Timeline

• Study Start: 1992-09
• Primary Completion: 1997-12
• Study Completion: 1997-12
• Status Verified: 2008-06
• Study First Submitted: 2008-06-12
• Study First Submitted QC: 2008-06-13
• Last Update Submitted: 2008-06-13
• Study First Posted: 2008-06-16
• Last Update Posted: 2008-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant	HSV seropositive subjects
Group B	Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant	HSV seronegative subjects
Group C	Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant	HSV seropositive subjects
Group D	Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant	HSV seronegative subjects

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Clinical Trials Call Center; 🇧🇪 Gent, Belgium