Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults
Phase 1
Completed
- Conditions
- Herpes Simplex
- Interventions
- Biological: Herpes simplex candidate (gD) vaccine GSK208141
- Registration Number
- NCT00698893
- Lead Sponsor
- GlaxoSmithKline
- 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 also be evaluated.
- Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A Herpes simplex candidate (gD) vaccine GSK208141 - Group B Herpes simplex candidate (gD) vaccine GSK208141 -
- Primary Outcome Measures
Name Time Method To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms Throughout the study Measurement of haematology/biochemical parameters on blood samples Throughout the study Vaccine reactogenicity by soliciting of local and general signs/symptoms On the day of vaccination and the subsequent 7 days Vaccine immunogenicity by 6 measurements of anti-HSV antibodies From day 0 to day 45 following vaccination
- Secondary Outcome Measures
Name Time Method