Last updated: 11/07/2018 13:03:49
Evaluation of immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with/without adjuvant
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Study in healthy HSV positive and HSV negative adults to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals' herpes simplex (gD) candidate vaccine with or without adjuvant
Trial description: The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
To evaluate the immunogenicity of herpes simplex vaccine, with or without MPL, in healthy adult HSV seropositive and HSV seronegative volunteers
Timeframe: Days 0, 30, 60, 180 and 365 after vaccination
To evaluate the reactogenicity and safety of the MPL-containing and non-MPL-containing vaccine in healthy adult HSV seronegative and seropositive volunteers
Timeframe: Reactogenicity from day 0 to day 6 after vaccination. Safety from day 0 to day 365 after vaccination
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
80
Primary completion date:
1997-31-12
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
Prophylaxis herpes simplex
Product
Herpes Simplex Vaccine
Collaborators
Not applicable
Study date(s)
September 1992 to December 1997
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 40 Years
Accepts healthy volunteers
Yes
- Between 18 and 40 years of age
- Written informed consent
- History of persistent hepatic, renal, cardiac or respiratory diseases.
- Clinical signs of acute illness at the time of entry into the study.
Inclusion and exclusion criteria
Inclusion criteria:
- Between 18 and 40 years of age
- Written informed consent
- Female volunteers must be using contraceptive and should avoid becoming pregnant for the duration of this study.
- Good clinical condition as evidenced by history taking and physical examination
Exclusion criteria:
- History of persistent hepatic, renal, cardiac or respiratory diseases.
- Clinical signs of acute illness at the time of entry into the study.
- Seropositive for antibodies against the human immunodeficiency virus (HIV).
- Pregnancy, lactation.
- Treatment with corticosteroids or immunomodulating drugs.
- Simultaneous participation in another clinical trial.
- Any previous history of allergy.
- Any concomitant vaccination or administration of immunoglobulin during the study period.
- Any abnormal laboratory value among the tests performed at screening
Trial location(s)
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
1997-31-12
Actual study completion date
1997-31-12
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
Additional information
Not applicable
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