GSK: Protocol Summary for 208141/001

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Protocol Summary for 208141/001

Protocol Summary
Protocol Id:	208141/001
Secondary Ids:
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
Phase:	phase 1
Acronym:
FDA Regulated Intervention?:
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Belgium: Institutional Review Board
Collaborators:
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
Record Verification Date:	July 2010
Status:	Completed
Why Study Stopped:
Study Start Date:	May 1992
Study Completion Date:	July 1992
Study Completion Date Type:	Actual
Primary Completion Date:	July 1992
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:	Non-randomized
Masking:	Open Label
Masked Subject:	false
Masked Caregiver:	false
Masked Investigator:	false
Masked Assessor:	false
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	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 Outcomes:
Conditions:	Prophylaxis herpes simplex
Keywords:	Herpes simplex Herpes simplex candidate (gD) vaccine
Eligibility Criteria:	Click to view inclusion/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
Gender:	Both
Minimum Age:	18 Year
Maximum Age:	40 Year
Enrollment:	16
Enrollment Type:	Actual
Healthy Volunteers?:	yes
Central Contact:	US GSK Clinical Trials Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:	EU GSK Clinical Trials Call Center
Backup Central Contact Phone:	+44 (0) 20 8990 4466
Backup Central Contact Email:	GSKClinicalSupportHD@gsk.com
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	No locations currently recruiting for this study.

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Protocol Summary for 208141/001