Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects - Full Text View

Purpose

This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.

Condition	Intervention	Phase
Prophylaxis for Herpes Simplex	Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141 Biological: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Study to Evaluate the Safety of GSK Biologicals' Herpes Simplex Candidate Vaccine (gD2t) With MPL in HSV Seropositive or Seronegative Subjects Without Genital Herpes Disease

Resource links provided by NLM:

MedlinePlus related topics: Genital Herpes Herpes Simplex

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

To compare between herpes simplex vaccine and placebo recipients the general safety of the vaccine by recording all the unsolicited adverse experiences and all serious adverse experiences [ Time Frame: During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs) ]

Secondary Outcome Measures:

To compare between vaccine and placebo recipients the incidence and severity of the reactogenicity as measured by recording the local reactions and the general symptoms [ Time Frame: On the day of each vaccination and on the following 3 days ]
To compare between vaccine and placebo recipients the effect on the haematological and biochemical parameters in subjects from 20% of the centers in each country [ Time Frame: At day -90 to day -7, and at month 7 and month 13 ]
To compare between vaccine and placebo recipients the effect on pre-existing herpes simplex virus infection by recording the frequency and severity of all herpes simplex clinical episodes [ Time Frame: Day 0 through month 19 ]
To evaluate the incidence and the types of the serious adverse experiences in both groups [ Time Frame: Month 7 to month 19 ]
To evaluate the humoral immune response to the vaccine by measuring the anti-gD2 antibodies in a subset of vaccine and placebo recipients from each of the serostatus groups [ Time Frame: Before vaccination, and one month and 7 months after vaccination ]
To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients [ Time Frame: At months 7 and 13 ]

Enrollment:	7460
Study Start Date:	October 1996
Study Completion Date:	April 1999
Primary Completion Date:	April 1999 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A	Biological: Herpes simplex candidate vaccine- adjuvanted GSK 208141 Intramuscular injection, 3 doses
Placebo Comparator: Group B	Biological: Placebo Intramuscular injection, 3 doses

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18 years of age and over at the time of first vaccination
Written informed consent
Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control

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 drug or vaccine concurrent with this study or during the period beginning 30 days prior to entry into the study or 5 half-lives of the drug
Recent history of alcoholism or drug abuse
Recent clinical history or evidence of significant hepatic disease
History of a current acute or chronic auto immune 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698568

Show 47 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Isabelle Harpigny, GSK
ClinicalTrials.gov Identifier:	NCT00698568 History of Changes
Other Study ID Numbers:	208141/016
Study First Received:	June 16, 2008
Last Updated:	June 16, 2008
Health Authority:	Australia: Human Research Ethics Committee Austria: Ethikkommission Belgium: Institutional Review Board Canada: Health Canada France: Ministry of Health Germany: Ministry of Health South Africa: Department of Health Spain: Ministry of Health Switzerland: Ethikkommission United States: Food and Drug Administration Denmark: National Board of Health

Keywords provided by GlaxoSmithKline:

Herpes simplex, Herpes simplex candidate vaccine

Additional relevant MeSH terms:

Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013