Status:
COMPLETED
Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines
Lead Sponsor:
GlaxoSmithKline
Conditions:
Prophylaxis Herpes Simplex
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two ...
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
Eligibility Criteria
Inclusion
- Between 18 and 45 years of age
- Written informed consent
- Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course
- Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV seropositive by gD2 ELISA before entry
Exclusion
- Any previous vaccination against Herpes simplex.
- Any previous administration of MPL.
- Pregnancy or lactation.
- Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind.
- Clinical signs of acute or febrile illness at the time of entry into the study.
- Any administration of immunoglobulins during the vaccination course or within one month of vaccination.
- Any vaccination within one week of study vaccination.
- Previous known hypersensitivity to vaccination or to any component of the vaccine.
- Simultaneous participation in any other clinical trial with an investigational drug or vaccine. Subjects currently in a follow-up period of a vaccine study can be included.
- Recent history of alcoholism or drug abuse (within the past 6 months).
- Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, hepatic, renal, hematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
Key Trial Info
Start Date :
August 1 1995
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 1997
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00698490
Start Date
August 1 1995
End Date
January 1 1997
Last Update
June 17 2008
Active Locations (1)
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1
GSK Clinical Trials Call Center
Ghent, Belgium