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

Primary Purpose

Herpes Simplex

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Herpes simplex candidate vaccine- adjuvanted GSK208141

Placebo injection

About this trial

This is an interventional prevention trial for Herpes Simplex focused on measuring Herpes simplex candidate vaccine, Herpes simplex

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Outcomes

Primary Outcome Measures

To compare between herpes simplex vaccine (gD2t with adjuvant) and placebo the general safety of the vaccine by recording all the unsolicited adverse experiences

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

Secondary Outcome Measures

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

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

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

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

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.

Full Information

NCT ID

NCT00699764

First Posted

June 17, 2008

Last Updated

September 6, 2016

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00699764

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

March 1996 (undefined)

Primary Completion Date

October 1999 (Actual)

Study Completion Date

October 1999 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Simplex

Keywords

Herpes simplex candidate vaccine, Herpes simplex

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

2491 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Title

Group B

Arm Type

Placebo Comparator

Intervention Type

Biological

Intervention Name(s)

Herpes simplex candidate vaccine- adjuvanted GSK208141

Intervention Description

Intramuscular injection, 3 doses

Intervention Type

Biological

Intervention Name(s)

Placebo injection

Other Intervention Name(s)

Herpes simplex candidate vaccine- adjuvanted GSK208141

Intervention Description

Intramuscular injection, 3 doses

Primary Outcome Measure Information:

Title

To compare between herpes simplex vaccine (gD2t with adjuvant) and placebo the general safety of the vaccine by recording all the unsolicited adverse experiences

Time Frame

During the 7 month vaccination period

Title

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

Time Frame

Survival analysis beginning at Month 0

Secondary Outcome Measure Information:

Title

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

Time Frame

Survival analysis beginning at Month 0

Title

Time Frame

Survival analysis beginning at Month 0

Title

Time Frame

After 3 doses of vaccine (between months 7 and 19)

Title

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

Time Frame

Survival analysis beginning at Month 0

Title

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

Title

To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent HSV infection in healthy female adults who are HSV seronegative at baseline.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Citations:

PubMed Identifier

12444179

Citation

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.

Results Reference

background

PubMed Identifier

23313657

Citation

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.

Results Reference

background

PubMed Identifier

18845199

Citation

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.

Results Reference

background

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208141/017

Available IPD/Information Comments

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

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208141/017

Available IPD/Information Comments

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

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208141/017

Available IPD/Information Comments

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

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208141/017

Available IPD/Information Comments

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

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208141/017

Available IPD/Information Comments

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

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

208141/017

Available IPD/Information Comments

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

Learn more about this trial

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

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