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| 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 |
| Estimated Enrollment: | 8326 |
| Study Start Date: | January 2003 |
| Estimated Study Completion Date: | November 2009 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study 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 | |
More Information
| 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 |
|
genital herpes, Herpes Simplex, vaccine, women |
|
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 |