EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with newly acquired genital herpes disease, caused by either Herpes Simplex Virus (HSV)-1 or HSV-2
Timeframe: Between Months 2 and 20
Secondary outcomes:
Number of subjects with newly acquired genital herpes disease, caused by either Herpes Simplex Virus (HSV)-1 or HSV-2
Timeframe: 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.
Timeframe: 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
Timeframe: Between Months 7 and 20
Concentrations for anti-glycoprotein D (anti-gD) antibodies.
Timeframe: At Months 0, 2, 6, 7, 12, 16 and 20
Titers for anti-herpes simplex virus (anti-HSV) neutralizing antibodies.
Timeframe: At Months 0, 2, 6, 7, 12, 16 and 20
Number of subjects reporting solicited local and general symptoms
Timeframe: Within 7 days (Days 0-6) after vaccination
Number of subjects reporting Grade 3 solicited local symptoms
Timeframe: Within 7 days (Days 0-6) after vaccination
Number of subjects reporting Grade 3 and Related solicited general symptoms
Timeframe: Within 7 days (Days 0-6) after vaccination
Number of subjects reporting Unsolicited Adverse Events (AEs)
Timeframe: Within 31 days after vaccination
Number of subjects with new onset chronic diseases (NOCDs), medically significant conditions (MSCs) and Serious Adverse Events (SAEs)
Timeframe: Throughout the study (From Month 0 up to Month 20)
Number of subjects reporting Serious Adverse Events (SAEs)
Timeframe: Throughout the study (From Month 0 up to Month 20)
Interventions:
Enrollment:
8323
Primary completion date:
2009-22-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Tavares F et al. (2013) Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit Herpes Simplex Virus vaccine. Vaccine. 31(13):1759-1764. doi: 10.1016/j.vaccine.2013.01.002.
Medical condition
Herpes simplex infection
Product
SB208109, SB208141
Collaborators
Not applicable
Study date(s)
January 2003 to August 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female
Age
18 - 30 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V3R 8P8
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35294
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11201
Status
Study Complete
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Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2009-22-08
Actual study completion date
2009-22-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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