Last updated: 11/04/2018 00:45:22

Safety of a Herpes Simplex candidate vaccine (gD2t) with MPL and its efficacy to prevent genital herpes disease

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GSK study ID
208141/017
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Clinicaltrials.gov ID
NCT00699764
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Safety of SmithKline Beecham Biologicals' Herpes Simplex candidate vaccine (gD2t) with MPL & its efficacy to prevent genital herpes disease in HSV positive or negative consorts of subjects with genital herpes disease
Trial description: The purpose of the study is to evaluate the safety of Herpes Simplex candidate vaccine (gD2t) with adjuvant and its efficacy to prevent genital herpes disease in HSV positive or negative consorts of subjects with genital herpes disease.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

To compare between herpes simplex vaccine (gD2t with adjuvant) and placebo the general safety of the vaccine by recording all the unsolicited adverse experiences

Timeframe: During the 7 month vaccination period

To evaluate the protective efficacy of gD2t with adjuvant to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV seropositive at baseline

Timeframe: Survival analysis beginning at Month 0

Secondary outcomes:

To evaluate the protective efficacy of gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative at baseline

Timeframe: Survival analysis beginning at Month 0

To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy male and female adults who are HSV seronegative or HSV-1 seropositive at baseline

Timeframe: Survival analysis beginning at Month 0

To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent acquisition of genital herpes disease in healthy female adults who are HSV seronegative or HSV-1 seropositive at baseline

Timeframe: After 3 doses of vaccine (between months 7 and 19)

To evaluate the protective efficacy of the gD2t with adjuvant vaccine to prevent symptoms of genital herpes disease in healthy female adults who are HSV seronegative at baseline

Timeframe: Survival analysis beginning at Month 0

Interventions:
  • Biological/vaccine: Herpes simplex candidate vaccine- adjuvanted GSK208141
  • Biological/vaccine: Placebo injection
    • Enrollment:
    2491
    Primary completion date:
    1999-31-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Stanberry LR et al. (2002) Glycoprotein-D-adjuvant vaccine to prevent genital herpes. N Engl J Med. 347(21):1652-1661.
    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.
    Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
    Medical condition
    Herpes Simplex
    Product
    Herpes Simplex Vaccine
    Collaborators
    Not applicable
    Study date(s)
    March 1996 to July 2001
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 45 years
    Accepts healthy volunteers
    Yes
    • Between 18 and 45 years of age at the time of first vaccination
    • Written informed consent
    • Any previous history of or current clinical signs or symptoms of genital herpes disease.
    • Any previous vaccination against herpes simplex.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Between 18 and 45 years of age at the time of first vaccination
    • Written informed consent
    • Females of childbearing potential must have a negative pregnancy test at enrollment and be using an accepted method of birth control
    • The volunteers must have a regular sexual partner with genital herpes disease confirmed by medical history
    Exclusion criteria:
    • Any previous history of or current clinical signs or symptoms of genital herpes disease.
    • Any previous vaccination against herpes simplex.
    • Any previous administration of MPL.
    • History of herpetic keratitis.
    • History of erythema multiforme.
    • Female subjects who are pregnant, lactating or planning a pregnancy before one month after the last vaccine dose.
    • Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. Topical corticoid therapy is allowed.
    • HIV positive at the time of enrollment
    • Clinical signs of acute or febrile illness at the time of entry into the study.
    • Any continuous suppressive antiviral oral therapy within the 6 months prior to entry.
    • Any administration of immunoglobulins during the vaccination course or within one month prior to the first vaccination.
    • Any vaccine administration less than one week before or after a study vaccination.
    • Previous known hypersensitivity to vaccination or to any component of the vaccine.
    • Simultaneous participation in any other clinical trial of an investigational compound.
    • Recent history of alcoholism or drug abuse
    • Recent clinical history or evidence of significant hepatic disease
    • Recent clinical history or evidence of renal dysfunction
    • Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, haematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
    • Inability or unwillingness to comply with the protocol or not expected to complete the study period

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    1999-31-10
    Actual study completion date
    2001-25-07

    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

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