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

Safety of SmithKline Beecham Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL & Its Efficacy to Prevent Genital Herpes Disease in HSV Positive or Negative Consorts of Subjects With Genital Herpes Disease

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.

Study Overview

• Status: Completed
• Conditions: Herpes Simplex
• Intervention / Treatment: Biological: Herpes simplex candidate vaccine- adjuvanted GSK208141; Biological: Placebo injection

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

• Study Type: Interventional
• Enrollment (Actual): 2491
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Biological: Herpes simplex candidate vaccine- adjuvanted GSK208141; Intramuscular injection, 3 doses
Placebo Comparator: Group B	Biological: Placebo injection; Intramuscular injection, 3 doses; Other Names: Herpes simplex candidate vaccine- adjuvanted GSK208141

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare between herpes simplex vaccine (gD2t with adjuvant) and placebo the general safety of the vaccine by recording all the unsolicited adverse experiences	During the 7 month vaccination period
To evaluate the protective efficacy of gD2t with adjuvant to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV seropositive at baseline	Survival analysis beginning at Month 0

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative at baseline	Survival analysis beginning at Month 0
To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy male and female adults who are HSV seronegative or HSV-1 seropositive at baseline	Survival analysis beginning at Month 0
To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV-1 seropositive at baseline	After 3 doses of vaccine (between months 7 and 19)
To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent symptoms of genital herpes disease in healthy female adults who are HSV seronegative at baseline	Survival analysis beginning at Month 0
To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent HSV infection in healthy female adults who are HSV seronegative or HSV-1 seropositive at baseline
To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent HSV infection in healthy female adults who are HSV seronegative at baseline.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: March 1, 1996
• Primary Completion (Actual): October 1, 1999
• Study Completion (Actual): October 1, 1999

Study Registration Dates

• First Submitted: June 17, 2008
• First Submitted That Met QC Criteria: June 17, 2008
• First Posted (Estimate): June 18, 2008

Study Record Updates

• Last Update Posted (Estimate): September 7, 2016
• Last Update Submitted That Met QC Criteria: September 6, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Herpes simplex; Herpes simplex candidate vaccine
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Herpes Simplex; Herpes Genitalis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 208141/017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 208141/017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 208141/017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 208141/017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 208141/017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Dataset Specification
   Information identifier: 208141/017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 208141/017
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register