Status:
COMPLETED
Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects
Lead Sponsor:
GlaxoSmithKline
Conditions:
Prophylaxis for Herpes Simplex
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 1999
Estimated Enrollment :
7460 Patients enrolled
Trial Details
Trial ID
NCT00698568
Start Date
October 1 1996
End Date
April 1 1999
Last Update
June 17 2008
Active Locations (47)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Clinical Trials Call Center
La Jolla, California, United States, 92037
2
GSK Clinical Trials Call Center
Middle Valley, California, United States, 94941
3
GSK Clinical Trials Call Center
San Diego, California, United States, 92128
4
GSK Clinical Trials Call Center
Denver, Colorado, United States, 80262