HerpeVac Trial for Young Women

NCT ID: NCT00057330

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 8323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-14
• Study Completion Date: 2009-08-22

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.

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.

Conditions

Herpes Simplex Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Herpes Simplex Virus Group

Females 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.

Group Type: EXPERIMENTAL

HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine

Intervention Type: BIOLOGICAL

the vaccine was administered intramuscularly in the non-dominant deltoid

Havrix Group

Females 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.

Group Type: EXPERIMENTAL

Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine

Intervention Type: BIOLOGICAL

the vaccine was administered intramuscularly in the non-dominant deltoid

Interventions

HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine

the vaccine was administered intramuscularly in the non-dominant deltoid

Intervention Type: BIOLOGICAL

Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine

the vaccine was administered intramuscularly in the non-dominant deltoid

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Mesa, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Phoenix, Arizona, United States

GSK Investigational Site

Tempe, Arizona, United States

GSK Investigational Site

Carson, California, United States

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

San Francisco, California, United States

GSK Investigational Site

Torrance, California, United States

GSK Investigational Site

Vallejo, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Athens, Georgia, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Augusta, Georgia, United States

GSK Investigational Site

Satesboro, Georgia, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Bloomington, Indiana, United States

GSK Investigational Site

Indianapolis, Indiana, United States

GSK Investigational Site

Iowa City, Iowa, United States

GSK Investigational Site

Arkansas City, Kansas, United States

GSK Investigational Site

Newton, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Wichita, Kansas, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Louisville, Kentucky, United States

GSK Investigational Site

Baton Rouge, Louisiana, United States

GSK Investigational Site

New Orleans, Louisiana, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

College Park, Maryland, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Omaha, Nebraska, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Brooklyn, New York, United States

GSK Investigational Site

Brooklyn, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Stony Brook, New York, United States

GSK Investigational Site

The Bronx, New York, United States

GSK Investigational Site

Chapel Hill, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Portland, Oregon, United States

GSK Investigational Site

Greenville, Pennsylvania, United States

GSK Investigational Site

Grove City, Pennsylvania, United States

GSK Investigational Site

Johnstown, Pennsylvania, United States

GSK Investigational Site

Monongahela, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Wexford, Pennsylvania, United States

GSK Investigational Site

Kingston, Rhode Island, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Webster, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

La Crosse, Wisconsin, United States

GSK Investigational Site

Edmonton, Alberta, Canada

GSK Investigational Site

Surrey, British Columbia, Canada

GSK Investigational Site

Winnipeg, Manitoba, Canada

GSK Investigational Site

Halifax, Nova Scotia, Canada

GSK Investigational Site

Truro, Nova Scotia, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Beauport, Quebec, Canada

GSK Investigational Site

Sherbrooke, Quebec, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 35199165 (View on PubMed)

Belshe 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.

Reference Type: DERIVED

PMID: 24285844 (View on PubMed)

Belshe 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.

Reference Type: DERIVED

PMID: 22216840 (View on PubMed)

Other Identifiers

208141/039

Identifier Type: OTHER

Identifier Source: secondary_id

208141/039

Identifier Type: -

Identifier Source: org_study_id