Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease

NCT ID: NCT00699764

Last Updated: 2016-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2491 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-03-31
• Study Completion Date: 1999-10-31

Brief Summary

The purpose of the study is to evaluate the safety of Herpes Simplex candidate vaccine (gD2t) with adjuvant and its efficacy to prevent genital herpes disease in HSV positive or negative consorts of subjects with genital herpes disease.

Detailed Description

This study was monitored by a Data Safety Monitoring Board At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Conditions

Herpes Simplex

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group A

Group Type: EXPERIMENTAL

Herpes simplex candidate vaccine- adjuvanted GSK208141

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Group B

Group Type: PLACEBO_COMPARATOR

Placebo injection

Intervention Type: BIOLOGICAL

Intramuscular injection, 3 doses

Interventions

Herpes simplex candidate vaccine- adjuvanted GSK208141

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Placebo injection

Intramuscular injection, 3 doses

Intervention Type: BIOLOGICAL

Other Intervention Names

Herpes simplex candidate vaccine- adjuvanted GSK208141

Eligibility Criteria

Inclusion Criteria

• Between 18 and 45 years of age at the time of first vaccination
• Written informed consent
• Females of childbearing potential must have a negative pregnancy test at enrollment and be using an accepted method of birth control
• The volunteers must have a regular sexual partner with genital herpes disease confirmed by medical history

Exclusion Criteria

• Any previous history of or current clinical signs or symptoms of genital herpes disease.
• Any previous vaccination against herpes simplex.
• Any previous administration of MPL.
• History of herpetic keratitis.
• History of erythema multiforme.
• Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose.
• Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed.
• HIV positive at the time of enrollment
• Clinical signs of acute or febrile illness at the time of entry into the study.
• Any continuous suppressive antiviral oral therapy within the 6 months prior to entry.
• Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination.
• Any vaccine administration less than one week before or after a study vaccination.
• Previous known hypersensitivity to vaccination or to any component of the vaccine.
• Simultaneous participation in any other clinical trial of an investigational compound.
• Recent history of alcoholism or drug abuse
• Recent clinical history or evidence of significant hepatic disease
• Recent clinical history or evidence of renal dysfunction
• Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
• Inability or unwillingness to comply with the protocol or not expected to complete the study period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

References

Stanberry LR, Spruance SL, Cunningham AL, Bernstein DI, Mindel A, Sacks S, Tyring S, Aoki FY, Slaoui M, Denis M, Vandepapeliere P, Dubin G; GlaxoSmithKline Herpes Vaccine Efficacy Study Group. Glycoprotein-D-adjuvant vaccine to prevent genital herpes. N Engl J Med. 2002 Nov 21;347(21):1652-61. doi: 10.1056/NEJMoa011915.

Reference Type: BACKGROUND

PMID: 12444179 (View on PubMed)

Tavares F, Cheuvart B, Heineman T, Arellano F, Dubin G. Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit herpes simplex virus vaccine. Vaccine. 2013 Mar 25;31(13):1759-64. doi: 10.1016/j.vaccine.2013.01.002. Epub 2013 Jan 10.

Reference Type: BACKGROUND

PMID: 23313657 (View on PubMed)

Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

Reference Type: BACKGROUND

PMID: 18845199 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

208141/017

Identifier Type: -

Identifier Source: org_study_id