Status:
COMPLETED
Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Herpes Simplex
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will al...
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 40 years of age
- Seropositive for antibodies against HSV
- Female volunteers must have been using contraceptives for at least 2 months before the entry and should avoid becoming pregnant for the duration of this study.
- Good physical condition as established by physical examination and history taking at the time of entry
Exclusion
- Any abnormal laboratory value among the tests performed at screening.
- History of persistent hepatic, renal, cardiac or respiratory diseases
- Clinical signs of acute illness at the time of entry into the study.
- Previous history of asthma or hypersensitivity to drugs.
- Seropositive for antibodies against the human immunodeficiency virus
- Pregnancy and lactation.
- Treatment with corticosteroids or immunomodulating drugs.
- Simultaneous participation in another clinical trial.
- Administration of any other vaccine or immunoglobulins during the study period
Key Trial Info
Start Date :
May 1 1992
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 1992
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00698893
Start Date
May 1 1992
End Date
July 1 1992
Last Update
June 2 2017
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