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HerpeVac Trial for Young Women
This study is ongoing, but not recruiting participants.
First Received: March 31, 2003   Last Updated: September 25, 2008   History of Changes
Sponsor: GlaxoSmithKline
Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00057330
  Purpose

The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected. The study will enroll approximately 7550 healthy women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine (experimental group) or hepatitis A vaccine (control group). Participants will receive their assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and additional unscheduled visits for an evaluation of herpes if it is suspected. Participants will be involved in study related procedures for up to 20 months.


Condition Intervention Phase
Herpes Simplex
Biological: HSV Vaccine
Biological: Hepatitis A Vaccine
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: A Double-Blind, Randomized, Controlled Phase III Study to Assess the Prophylactic Efficacy and Safety of gD-Alum/MPL Vaccine in the Prevention of Genital Herpes Disease in Young Women Who Are HSV-1 and -2 Seronegative

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Estimated Enrollment: 8326
Study Start Date: January 2003
Estimated Study Completion Date: November 2009
Detailed Description:

This study is a double-blind, randomized, controlled Phase III trial to assess the prophylactic efficacy and safety of gD-Alum/MPL vaccine in the prevention of genital herpes disease in young women who are herpes simplex virus (HSV)-1 and -2 seronegative. The primary efficacy objective is to evaluate vaccine efficacy in the prevention of genital herpes disease caused by HSV-1 and/or HSV-2 between months 2 and 20 in healthy adult women who were initially HSV-1 and HSV-2 seronegative. The secondary efficacy objectives are to: evaluate vaccine efficacy in the prevention of genital herpes disease caused by HSV-1 and/or HSV-2 occurring between the months 7 and 20; evaluate vaccine efficacy in the prevention of HSV-2 infection between months 2 and 20; and to evaluate vaccine efficacy in the prevention of HSV-2 infection occurring between months 7 and 20. The study will enroll approximately 7,550 women, ages 18-30 years. Participants will be randomized to 1 of 2 possible study groups: candidate vaccine; or control vaccine (hepatitis A vaccine). The study duration for each subject will be approximately 20 months. Study procedures will include 9 scheduled study visits (including the screening visit) and additional unscheduled visits for evaluation of suspected herpes disease episodes. Three doses of vaccine or control will be administered intramuscularly in the non-dominant deltoid on a 0, 1, and 6 month schedule. Subjects will attend clinic visits at screening, months 2, 7, 12, 16, and 20. In subjects who present with suspected herpes disease between months 17 and 20, an additional visit to collect a serum sample will be scheduled 3 months after the evaluation for suspected genital herpes.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A female between, and including, 18 and 30 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Seronegative for HSV-1 and HSV-2 by Western blot.
  • Subject must be non-childbearing potential, i.e. either surgically sterilized or, if of child bearing potential, she must be using a highly effective method of birth control (e.g., intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant®; DepoProvera®; contraceptive skin patch or cervical ring) for 30 days prior to vaccination, have a negative urine pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series.
  • A subject for whom the investigator believes can and will comply with the requirements of the protocol (e.g. completion of the memory aid/diary cards, return for follow-up visits, accessible by phone or pager, able to self-sample and not planning on moving from study area).

Exclusion Criteria:

  • Pregnant or nursing female.
  • Clinical signs or symptoms of current oro-labial, genital or non-genital HSV disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, pain, burning, itching, tingling or dysuria.
  • Previous vaccination against herpes.
  • Previous administration of monophosphoryl lipid A (MPL) adjuvant (no vaccines currently licensed in the USA contain this).
  • History of any confirmed oro-labial, genital or non-genital HSV disease or infection.
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Planned administration/ administration of a non-study vaccine within 30 days of the first dose of the study vaccine with the following exceptions: Administration of routine Meningococcal, Hepatitis B, inactivated Influenza, and Diphtheria/Tetanus vaccine up to 8 days before the first dose of study vaccine is allowed.
  • History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines, e.g. aluminum, MPL, alum-MPL, 2-phenoxyethanol or neomycin.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition including, human immunodeficiency virus (HIV) infection.
  • Acute or chronic, clinically significant (unresolved, requiring on-going medical management or medication, etc.) pulmonary, cardiovascular, hepatic or renal function abnormality, as determined by medical history or physical examination.
  • Acute disease at the time of enrollment (defer vaccination until subject recovers). Acute disease is defined as the presence of a moderate or severe illness with or without fever. Study vaccine can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness.
  • Oral temperature greater than or equal to 99.5º F (greater than or equal to 37.5º C) / axillary temperature greater than or equal to 99.5º (greater than or equal to 37.5º C) / tympanic temperature on oral setting greater than or equal to 99.5º F (greater than or equal to 37.5º C).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone or, equivalent, greater than or equal to 0.5 mg/kg/day. Inhaled or topical steroids are allowed.)
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Recent history of chronic alcohol consumption (defined as more than 5 oz of ethanol [absolute alcohol] per day) and/or drug abuse.
  • History of sexually transmitted infection within 30 days preceding the first dose of study vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00057330

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
East Valley Family Physicians
Chandler, Arizona, United States, 85224
Fiel Family and Sports Medicine, PLLC
Tempe, Arizona, United States, 85283
Central Phoenix Medical Clinic, Llc
Phoenix, Arizona, United States, 85014
Desert Clinical Research
Mesa, Arizona, United States, 85201
United States, California
San Diego State University
San Diego, California, United States, 92182
Medical Center for Clinical Research
San Diego, California, United States, 92108
Quest Clinical Research
San Francisco, California, United States, 94115
Solano Clinical Research
Davis, California, United States, 95616
University of California, Long Beach
Long Beach, California, United States, 90840
UCLA Center For Vaccine Research
Torrance, California, United States, 90502
California State University
Carson, California, United States, 90747
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80262
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Georgia Southern University
Statesboro, Georgia, United States, 30460
University of Georgia
Athens, Georgia, United States, 30602
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Heartland Research Associates West
Wichita, Kansas, United States, 67205
Heartland Research Associates Newton
Newton, Kansas, United States, 67114
Heartland Research Associates Arkansas City
Arkansas City, Kansas, United States, 67005
Heartland Research Associates, LLC
Wichita, Kansas, United States, 67207
United States, Kentucky
Kentucky Pediatric/Adult Research, Inc.
Bardstown, Kentucky, United States, 40004
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana State University
Baton Rouge, Louisiana, United States, 70808-4124
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70115
United States, Maryland
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201
University of Maryland College Park
College Park, Maryland, United States, 20742
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Meridian Clinical Research, LLC
Omaha, Nebraska, United States, 68134
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
University of Rochester Monroe County Health Department STD Clinic
Rochester, New York, United States, 14620
Jacobi Medical Center
Bronx, New York, United States, 10461
University of Rochester
Rochester, New York, United States, 14642
SUNY at Stony Brook
Stony Brook, New York, United States, 11794
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Mount Sinai Hospital
New York, New York, United States, 10029
The Brooklyn Hospital Center
Brooklyn, New York, United States, 11201
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7030
University of North Carolina UNC Clinical Research/Raleigh
Raleigh, North Carolina, United States, 27607
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
United States, Oklahoma
University of Oklahoma
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Westover Heights Clinic
Portland, Oregon, United States, 97210
United States, Pennsylvania
Primary Physicians Research Inc. Stotler
Johnstown, Pennsylvania, United States, 15904
Primary Physicians Research Inc. Family HealthCare Partners
Grove City, Pennsylvania, United States, 16127
Primary Physicians Research Inc. Wexford Medical Practice
Wexford, Pennsylvania, United States, 15090
Primary Physicians Research Inc. Susan L. Floyd, MD, PC
Wexford, Pennsylvania, United States, 15090
Primary Physicians Reseach Inc.
Pittsburgh, Pennsylvania, United States, 15241
United States, Rhode Island
South County Consultants in Clinical Trials
Kingston, Rhode Island, United States, 02881
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
Benchmark Research
Austin, Texas, United States, 78705
Baylor College of Medicine
Houston, Texas, United States, 77030
Center for Clinical Studies
Houston, Texas, United States, 77058
Center for Clinical Studies (171)
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
United States, Washington
University of Washington
Seattle, Washington, United States, 98122
United States, Wisconsin
University of Wisconsin
La Crosse, Wisconsin, United States, 54601
Canada
University of Manitoba
Winnipeg, Canada, R3E 0W3
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
TASC - CMX Research Services Inc
Surrey, British Columbia, Canada, V3R 8P8
Canada, Nova Scotia
Clinical Trials Research Center
Halifax, Nova Scotia, Canada, B3K 6R8
Colchester Research Group
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
PrimeHealth Clinical Research
Toronto, Ontario, Canada, M4S 1Y2
Canada, Quebec
Departement de Sante Publique
Beauport, Quebec, Canada, G1E 7G9
Diex Recherche
Sherbrooke, Quebec, Canada, J1H 1Z1
Sponsors and Collaborators
GlaxoSmithKline
  More Information

No publications provided

Study ID Numbers: 01-643, GSK No. 208141/039 (HSV-039)
Study First Received: March 31, 2003
Last Updated: September 25, 2008
ClinicalTrials.gov Identifier: NCT00057330     History of Changes
Health Authority: Unspecified

Keywords provided by GlaxoSmithKline:
genital herpes, Herpes Simplex, vaccine, women

Additional relevant MeSH terms:
Skin Diseases, Viral
Genital Diseases, Female
Virus Diseases
Herpes Simplex
Skin Diseases, Infectious
Sexually Transmitted Diseases, Viral
Skin Diseases
Herpes Genitalis
Sexually Transmitted Diseases
DNA Virus Infections
Genital Diseases, Male
Herpesviridae Infections

ClinicalTrials.gov processed this record on November 27, 2009