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
1 other identifier
interventional
2,491
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 1996
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 1999
CompletedFirst Submitted
Initial submission to the registry
June 17, 2008
CompletedFirst Posted
Study publicly available on registry
June 18, 2008
CompletedSeptember 7, 2016
September 1, 2016
3.6 years
June 17, 2008
September 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Group A
EXPERIMENTALGroup B
PLACEBO COMPARATORInterventions
Intramuscular injection, 3 doses
Intramuscular injection, 3 doses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Publications (3)
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.
PMID: 12444179BACKGROUNDTavares 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.
PMID: 23313657BACKGROUNDVerstraeten 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.
PMID: 18845199BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2008
First Posted
June 18, 2008
Study Start
March 1, 1996
Primary Completion
October 1, 1999
Study Completion
October 1, 1999
Last Updated
September 7, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.