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

Prophylaxis Herpes Simplex Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697567
• Other study ID #: 208141/002
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2008
• Last updated: June 13, 2008
• Start date: September 1992
• Est. completion date: December 1997

Study information

• Verified date: June 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 1997
• Est. primary completion date: December 1997
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Simplex
• Prophylaxis Herpes Simplex

Intervention

Biological:
• Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant
Intramuscular injection, 3 doses
• Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant
Intramuscular injection, 3 doses

Locations

Country	Name	City	State
Belgium	GSK Clinical Trials Call Center	Gent

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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