Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults
June 1, 2017 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
|
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
|
|
Experimental: Group B
|
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate the vaccine safety by repeated physical examination and by recording all local and general signs/symptoms
Time Frame: Throughout the study
|
Throughout the study
|
|
Measurement of haematology/biochemical parameters on blood samples
Time Frame: Throughout the study
|
Throughout the study
|
|
Vaccine reactogenicity by soliciting of local and general signs/symptoms
Time Frame: On the day of vaccination and the subsequent 7 days
|
On the day of vaccination and the subsequent 7 days
|
|
Vaccine immunogenicity by 6 measurements of anti-HSV antibodies
Time Frame: From day 0 to day 45 following vaccination
|
From day 0 to day 45 following vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 1992
Primary Completion (Actual)
July 1, 1992
Study Completion (Actual)
July 1, 1992
Study Registration Dates
First Submitted
June 13, 2008
First Submitted That Met QC Criteria
June 16, 2008
First Posted (Estimate)
June 17, 2008
Study Record Updates
Last Update Posted (Actual)
June 2, 2017
Last Update Submitted That Met QC Criteria
June 1, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 208141/001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.