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HERPEVAC Trial for Women Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about HERPEVAC Trial for Women conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. HERPEVAC Trial for Women Clinical research trials and HERPEVAC Trial for Women health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like HERPEVAC Trial for Women. HERPEVAC Trial for Women Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a HERPEVAC Trial for Women clinical trial. Human subjects often get the best healthcare available for their HERPEVAC Trial for Women condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > HERPEVAC Trial for Women  HERPEVAC Trial for Women
HERPEVAC Trial for Women
For Condition: Sexually Transmitted Diseases,Herpes Simplex
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The primary purpose of this study is to see if the vaccine is safe and prevents genital herpes disease in women who are not infected.
Details: Pivotal Phase III efficacy study. Experimental design: multi-center, double-blind, controlled and randomized. Indication: To prevent genital herpes disease in women who are uninfected. Control: Investigational formulation and schedule of a hepatitis A vaccine (Havrix). Treatment allocation: Randomized with balanced allocation (1:1). Blinding: Double-blind. The subjects and the study personnel will not know which treatment is being administered.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Active Control, Parallel Assignment
Minimum Age/Maximum Age: 18 Years/30 Years
Genders: Female
Protocol Entry 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 of nonchildbearing potential, i.e., either surgically sterilized or, if of childbearing 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 followup visits, accessible by phone or pager, able to self-sample and not planning on moving from study area). EXCLUSION CRITERIA: - Pregnant or nursing female. - 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 or mild upper respiratory infection with or without low-grade febrile illness. - 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. - History of previous or planned vaccination against hepatitis A or a history of hepatitis A infection. - 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 of a non-study vaccine within 30 days of the first dose of 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. - Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. - Acute or chronic, clinically significant (unresolved, requiring ongoing medical management or medication, etc.) pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination. - Temperature measured above oral temperature 99.5F/ axillary temperature 99.5F/ tympanic temperature on oral setting 99.5F. - 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, 0.5 mg/kg/day. Inhaled and 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 a sexually transmitted infection within 30 days preceding the first dose of study vaccine.
Total Enrollment: 7550
Location and Contact Information:
University of Alabama at Birmingham *Recruiting*
Birmingham, Alabama, 35294-3293
United States
Recruiting
Wexford *Recruiting*
Wexford, Pennsylvania, 15090
United States
Recruiting
Valley Women's Health *Recruiting*
Monongahela, Pennsylvania, 15063
United States
Recruiting
Westover Heights Clinic *Recruiting*
Portland, Oregon, 97210
United States
Recruiting
St. Louis University *Recruiting*
St. Louis, Missouri, 63110-2507
United States
Recruiting
Greenville Medical Center *Recruiting*
Greenville, Pennsylvania, 16125
United States
Recruiting
Indiana University *Recruiting*
Indianapolis, Indiana, 46202-4800
United States
Recruiting
University of California Long Beach Student Health Service *Recruiting*
Long Beach, California, 90840
United States
Recruiting
Primary Physician's Research, Inc. *Recruiting*
Pittsburgh, Pennsylvania, 15241
United States
Recruiting
University of North Carolina *Recruiting*
Raleigh, North Carolina, 27607
United States
Recruiting
Mount Sinai Medical Center *Recruiting*
New York City, New York, 10029
United States
Recruiting
University of Louisville *Recruiting*
Louisville, Kentucky, 40202
United States
Recruiting
University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599
United States
Recruiting
University of Utah School of Medicine *Recruiting*
Salt Lake City, Utah, 84132-2405
United States
Recruiting
SUNY Downstate *Recruiting*
Brooklyn, New York, 11203-2098
United States
Recruiting
University of Washington Virology Research Clinic *Recruiting*
Seattle, Washington, 98122-5312
United States
Recruiting
University of Iowa *Recruiting*
Iowa City, Iowa, 52242
United States
Recruiting
University of California - Los Angeles CA *Recruiting*
Torrance, California, 90502
United States
Recruiting
South County Consultants in Clinical Trials *Recruiting*
Kingston, Rhode Island, 02881
United States
Recruiting
Medical Center for Clinical Research *Recruiting*
San Diego, California, 92108
United States
Recruiting
California State University *Recruiting*
Carson, California, 90747
United States
Recruiting
Baylor College of Medicine - Houston TX (VTEU) *Recruiting*
Houston, Texas, 77030-3498
United States
Recruiting
Family HealthCare Partners *Recruiting*
Grove City, Pennsylvania, 16127
United States
Recruiting
University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80220
United States
Recruiting
University of Rochester - Rochester NY (VTEU) *Recruiting*
Rochester, New York, 14642
United States
Recruiting
Cincinnati Children's Hospital Med Ctr *Recruiting*
Cincinnati, Ohio, 45229
United States
Recruiting
UCLA - Dr. Bruksch *Recruiting*
Los Angeles, California, 90048
United States
Recruiting
University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting
Johns Hopkins University *Recruiting*
Baltimore, Maryland, 21287-0003
United States
Recruiting
Susan Floyd Wexford Professional Building *Recruiting*
Wexford, Pennsylvania, 15090
United States
Recruiting
University of Maryland *Recruiting*
College Park, Maryland, 20742
United States
Recruiting
Center for Clinical Studies - Houston, TX *Recruiting*
Houston, Texas, 77058
United States
Recruiting
Monroe County STD Clinic *Recruiting*
Rochester, New York, 14620
United States
Recruiting
Boston Medical Center *Recruiting*
Boston, Massachusetts, 02118
United States
Recruiting
Louisiana State University Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting
Center for Clinical Studies *Recruiting*
Houston, Texas, 77030
United States
Recruiting
Additional Information:
Study ID Numbers: 01-643;
Study Start Date: January 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057330
Other Herpes Simplex Studies:
1. HERPEVAC Trial for Women
Related Studies:
Other Herpes Simplex Clinical Trials
Other Maryland Clinical Trials
Other College Park Clinical Trials
HERPEVAC Trial for Women
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