Safety Evaluation of Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant in HSV Seropositive / Seronegative Subjects
NCT ID: NCT00698568
Last Updated: 2008-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
7460 participants
INTERVENTIONAL
1996-10-31
1999-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Herpes simplex candidate vaccine- adjuvanted GSK 208141
Intramuscular injection, 3 doses
Group B
Placebo
Intramuscular injection, 3 doses
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Herpes simplex candidate vaccine- adjuvanted GSK 208141
Intramuscular injection, 3 doses
Placebo
Intramuscular injection, 3 doses
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written informed consent
* Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control
Exclusion Criteria
* Any previous vaccination against herpes simplex.
* Any previous administration of MPL.
* History of herpetic keratitis.
* History of erythema multiforme.
* Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose
* Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed.
* HIV positive at the time of enrollment
* Clinical signs of acute or febrile illness at the time of entry into the study.
* Any continuous suppressive antiviral oral therapy within the 6 months prior to entry.
* Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination.
* Any vaccine administration less than one week before or after a study vaccination.
* Previous known hypersensitivity to vaccination or to any component of the vaccine.
* Simultaneous participation in any other clinical trial of an investigational drug or vaccine concurrent with this study or during the period beginning 30 days prior to entry into the study or 5 half-lives of the drug
* Recent history of alcoholism or drug abuse
* Recent clinical history or evidence of significant hepatic disease
* History of a current acute or chronic auto immune disease.
* Recent clinical history or evidence of renal dysfunction
* Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
* Inability or unwillingness to comply with the protocol or not expected to complete the study period
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
GSK
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Clinical Trials Call Center
La Jolla, California, United States
GSK Clinical Trials Call Center
Middle Valley, California, United States
GSK Clinical Trials Call Center
San Diego, California, United States
GSK Clinical Trials Call Center
Denver, Colorado, United States
GSK Clinical Trials Call Center
East Lyme, Connecticut, United States
GSK Clinical Trials Call Center
Atlanta, Georgia, United States
GSK Clinical Trials Call Center
Atlanta, Georgia, United States
GSK Clinical Trials Call Center
Indianapolis, Indiana, United States
GSK Clinical Trials Call Center
Des Moines, Iowa, United States
GSK Clinical Trials Call Center
Mission, Kansas, United States
GSK Clinical Trials Call Center
Louisville, Kentucky, United States
GSK Clinical Trials Call Center
Towson, Maryland, United States
GSK Clinical Trials Call Center
Newton, Massachusetts, United States
GSK Clinical Trials Call Center
Lansing, Michigan, United States
GSK Clinical Trials Call Center
St Louis, Missouri, United States
GSK Clinical Trials Call Center
St Louis, Missouri, United States
GSK Clinical Trials Call Center
Omaha, Nebraska, United States
GSK Clinical Trials Call Center
Albuquerque, New Mexico, United States
GSK Clinical Trials Call Center
Brooklyn, New York, United States
GSK Clinical Trials Call Center
Poughkeepsie, New York, United States
GSK Clinical Trials Call Center
Cincinnati, Ohio, United States
GSK Clinical Trials Call Center
Portland, Oregon, United States
GSK Clinical Trials Call Center
Philadelphia, Pennsylvania, United States
GSK Clinical Trials Call Center
Pittsburgh, Pennsylvania, United States
GSK Clinical Trials Call Center
Providence, Rhode Island, United States
GSK Clinical Trials Call Center
Charleston, South Carolina, United States
GSK Clinical Trials Call Center
Austin, Texas, United States
GSK Clinical Trials Call Center
Bryan, Texas, United States
GSK Clinical Trials Call Center
Dallas, Texas, United States
GSK Clinical Trials Call Center
Lake Jackson, Texas, United States
GSK Clinical Trials Call Center
Nassau Bay, Texas, United States
GSK Clinical Trials Call Center
San Antonio, Texas, United States
GSK Clinical Trials Call Center
Salt Lake City, Utah, United States
GSK Clinical Trials Call Center
Falls Church, Virginia, United States
GSK Clinical Trials Call Center
Seattle, Washington, United States
GSK Clinical Trials Call Center
Wenatchee, Washington, United States
GSK Clinical Trials Call Center
Sydney, New South Wales, Australia
GSK Clinical Trials Call Center
Vienna, , Austria
GSK Clinical Trials Call Center
Ghent, , Belgium
GSK Clinical Trials Call Center
Montreal, Quebec, Canada
GSK Clinical Trials Call Center
Copenhagen, , Denmark
GSK Clinical Trials Call Center
Grenoble, , France
GSK Clinical Trials Call Center
München, , Germany
GSK Clinical Trials Call Center
Carolina, , Puerto Rico
GSK Clinical Trials Call Center
Pretoria, , South Africa
GSK Clinical Trials Call Center
Madrid, , Spain
GSK Clinical Trials Call Center
Basel, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
208141/016
Identifier Type: -
Identifier Source: org_study_id