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

Herpes Simplex Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699764
• Other study ID #: 208141/017
• Status: Completed
• Phase: Phase 3
• First received: June 17, 2008
• Last updated: September 6, 2016
• Start date: March 1996
• Est. completion date: October 1999

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeUnited States: Institutional Review BoardItaly: Ministry of HealthCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2491
• Est. completion date: October 1999
• Est. primary completion date: October 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 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 Genitalis
• Herpes Simplex

Intervention

Biological:
• Herpes simplex candidate vaccine- adjuvanted GSK208141
Intramuscular injection, 3 doses
• Placebo injection
Intramuscular injection, 3 doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent HSV infection in healthy female adults who are HSV seronegative at baseline.

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