Last updated: 11/04/2018 00:43:23
Evaluation of safety of candidate gD vaccine, with or without MPL in healthy Herpes simplex virus-positive adults
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An open study in healthy Herpes simplex virus (HSV)-positive adults to evaluate the safety of GSK Biologicals’ candidate gD vaccine, with or without 3D MPL
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms
Timeframe: Throughout the study
Measurement of haematology/biochemical parameters on blood samples
Timeframe: Throughout the study
Vaccine reactogenicity by soliciting of local and general signs/symptoms
Timeframe: On the day of vaccination and the subsequent 7 days
Vaccine immunogenicity by 6 measurements of anti-HSV antibodies
Timeframe: From day 0 to day 45 following vaccination
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
16
Primary completion date:
1992-01-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
Medical condition
Herpes Simplex
Product
Herpes Simplex Vaccine
Collaborators
Not applicable
Study date(s)
May 1992 to July 1992
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 40 years
Accepts healthy volunteers
Yes
- Between 18 and 40 years of age
- Seropositive for antibodies against HSV
- Any abnormal laboratory value among the tests performed at screening.
- History of persistent hepatic, renal, cardiac or respiratory diseases
Inclusion and exclusion criteria
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
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
1992-01-07
Actual study completion date
1992-20-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 208141/001 can be found on the GSK Clinical Study Register
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