Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults
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
1 other identifier
interventional
16
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 1992
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1992
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 1992
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 1992
CompletedFirst Submitted
Initial submission to the registry
June 13, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedJune 2, 2017
June 1, 2017
2 months
June 13, 2008
June 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Group A
EXPERIMENTALGroup B
EXPERIMENTALInterventions
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Related Publications (1)
Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
PMID: 18845199BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2008
First Posted
June 17, 2008
Study Start
May 1, 1992
Primary Completion
July 1, 1992
Study Completion
July 1, 1992
Last Updated
June 2, 2017
Record last verified: 2017-06