HerpeVac Trial for Young Women
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
1 other identifier
interventional
8,323
2 countries
75
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2003
Longer than P75 for phase_3
75 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2003
CompletedFirst Submitted
Initial submission to the registry
March 31, 2003
CompletedFirst Posted
Study publicly available on registry
April 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2009
CompletedResults Posted
Study results publicly available
November 3, 2011
CompletedAugust 27, 2018
May 1, 2013
6.6 years
March 31, 2003
September 29, 2011
July 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2
Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2 was defined as a positive HSV-1 and/or HSV-2 Western blot in a subject with a previously negative Western blot result for the corresponding HSV type.
Between Months 2 and 20
Secondary Outcomes (11)
Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2
Between Months 7 and 20
Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion.
Between Months 2 and 20
Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion
Between Months 7 and 20
Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.
At Months 0, 2, 6, 7, 12, 16 and 20
Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.
At Months 0, 2, 6, 7, 12, 16 and 20
- +6 more secondary outcomes
Study Arms (2)
Herpes Simplex Virus Group
EXPERIMENTALFemales between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus (HSV) vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Havrix Group
EXPERIMENTALFemales between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Interventions
the vaccine was administered intramuscularly in the non-dominant deltoid
the vaccine was administered intramuscularly in the non-dominant deltoid
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (75)
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Mesa, Arizona, 85203, United States
GSK Investigational Site
Mesa, Arizona, 85213, United States
GSK Investigational Site
Phoenix, Arizona, 85014, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Tempe, Arizona, 85283, United States
GSK Investigational Site
Carson, California, 90747, United States
GSK Investigational Site
Long Beach, California, 90840, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
San Diego, California, 92108, United States
GSK Investigational Site
San Diego, California, 92182, United States
GSK Investigational Site
San Francisco, California, 94115, United States
GSK Investigational Site
Torrance, California, 90502, United States
GSK Investigational Site
Vallejo, California, 94589, United States
GSK Investigational Site
Aurora, Colorado, 80045, United States
GSK Investigational Site
Athens, Georgia, 30602, United States
GSK Investigational Site
Atlanta, Georgia, 30322, United States
GSK Investigational Site
Augusta, Georgia, 30912-3500, United States
GSK Investigational Site
Satesboro, Georgia, 30460, United States
GSK Investigational Site
Chicago, Illinois, 60612-7323, United States
GSK Investigational Site
Bloomington, Indiana, 47405, United States
GSK Investigational Site
Indianapolis, Indiana, 46202, United States
GSK Investigational Site
Iowa City, Iowa, 52242, United States
GSK Investigational Site
Arkansas City, Kansas, 67005, United States
GSK Investigational Site
Newton, Kansas, 67114, United States
GSK Investigational Site
Wichita, Kansas, 67205, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Lexington, Kentucky, 40536, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Baton Rouge, Louisiana, 70808, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
Baltimore, Maryland, 21224, United States
GSK Investigational Site
College Park, Maryland, 20742, United States
GSK Investigational Site
Boston, Massachusetts, 02118, United States
GSK Investigational Site
St Louis, Missouri, 63104, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Albuquerque, New Mexico, 87131-0001, United States
GSK Investigational Site
Brooklyn, New York, 11201, United States
GSK Investigational Site
Brooklyn, New York, 11203, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
Rochester, New York, 14620, United States
GSK Investigational Site
Rochester, New York, 14642, United States
GSK Investigational Site
Stony Brook, New York, 11794-8091, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Chapel Hill, North Carolina, 27599, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Cincinnati, Ohio, 45229, United States
GSK Investigational Site
Tulsa, Oklahoma, 74105, United States
GSK Investigational Site
Portland, Oregon, 97210, United States
GSK Investigational Site
Greenville, Pennsylvania, 16125, United States
GSK Investigational Site
Grove City, Pennsylvania, 16127, United States
GSK Investigational Site
Johnstown, Pennsylvania, 15904, United States
GSK Investigational Site
Monongahela, Pennsylvania, 15063, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Wexford, Pennsylvania, 15090, United States
GSK Investigational Site
Kingston, Rhode Island, 02881, United States
GSK Investigational Site
Nashville, Tennessee, 37232, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Webster, Texas, 77598, United States
GSK Investigational Site
Salt Lake City, Utah, 84119, United States
GSK Investigational Site
Salt Lake City, Utah, 84132-2405, United States
GSK Investigational Site
Seattle, Washington, 98104, United States
GSK Investigational Site
La Crosse, Wisconsin, 54601, United States
GSK Investigational Site
Edmonton, Alberta, T6G 2B7, Canada
GSK Investigational Site
Surrey, British Columbia, V3R 8P8, Canada
GSK Investigational Site
Winnipeg, Manitoba, R3E 0J9, Canada
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Toronto, Ontario, M4S 1Y2, Canada
GSK Investigational Site
Beauport, Quebec, G1E 7G9, Canada
GSK Investigational Site
Sherbrooke, Quebec, J1H 1Z1, Canada
Related Publications (3)
Belshe RB, Blevins TP, Yu Y, Nethington AE, Bellamy A, Bryant C, Morrison LA. Neutralizing Antibody Kinetics and Immune Protection Against Herpes Simplex Virus 1 Genital Disease in Vaccinated Women. J Infect Dis. 2023 Feb 14;227(4):522-527. doi: 10.1093/infdis/jiac067.
PMID: 35199165DERIVEDBelshe RB, Heineman TC, Bernstein DI, Bellamy AR, Ewell M, van der Most R, Deal CD. Correlate of immune protection against HSV-1 genital disease in vaccinated women. J Infect Dis. 2014 Mar;209(6):828-36. doi: 10.1093/infdis/jit651. Epub 2013 Nov 27.
PMID: 24285844DERIVEDBelshe RB, Leone PA, Bernstein DI, Wald A, Levin MJ, Stapleton JT, Gorfinkel I, Morrow RL, Ewell MG, Stokes-Riner A, Dubin G, Heineman TC, Schulte JM, Deal CD; Herpevac Trial for Women. Efficacy results of a trial of a herpes simplex vaccine. N Engl J Med. 2012 Jan 5;366(1):34-43. doi: 10.1056/NEJMoa1103151.
PMID: 22216840DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Out of the 8323 subjects enrolled and vaccinated, 7850 subjects were followed throughout the study, e. a. for safety and adverse event assessment (4488 in the Herpes Simplex Virus Group and 3662 in the Havrix Group).
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2003
First Posted
April 1, 2003
Study Start
January 14, 2003
Primary Completion
August 22, 2009
Study Completion
August 22, 2009
Last Updated
August 27, 2018
Results First Posted
November 3, 2011
Record last verified: 2013-05