Last updated: 11/07/2018 13:04:26
Safety evaluation of Herpes Simplex candidate vaccine (gD2t) with adjuvant in HSV seropositive / seronegative subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Study to evaluate the safety of GSK Biologicals’ Herpes Simplex candidate vaccine (gD2t) with MPL in HSV seropositive or seronegative subjects without genital herpes disease
Trial description: This study will evaluate, versus a placebo, the safety of Herpes simplex candidate vaccine with adjuvant in initially HSV seropositive or seronegative subjects who have no genital herpes disease.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
To compare between herpes simplex vaccine and placebo recipients the general safety of the vaccine by recording all the unsolicited adverse experiences and all serious adverse experiences
Timeframe: During a 30-day period after each vaccination (AEs), during 7 months after study start (SAEs)
Secondary outcomes:
To compare between vaccine and placebo recipients the incidence and severity of the reactogenicity as measured by recording the local reactions and the general symptoms
Timeframe: On the day of each vaccination and on the following 3 days
To compare between vaccine and placebo recipients the effect on the haematological and biochemical parameters in subjects from 20% of the centers in each country
Timeframe: At day -90 to day -7, and at month 7 and month 13
To compare between vaccine and placebo recipients the effect on pre-existing herpes simplex virus infection by recording the frequency and severity of all herpes simplex clinical episodes
Timeframe: Day 0 through month 19
To evaluate the incidence and the types of the serious adverse experiences in both groups
Timeframe: Month 7 to month 19
To evaluate the humoral immune response to the vaccine by measuring the anti-gD2 antibodies in a subset of vaccine and placebo recipients from each of the serostatus groups
Timeframe: Before vaccination, and one month and 7 months after vaccination
To compare the anti-gD2 antibody responses between the subsets of HSV double seronegative and HSV-1 seropositive only vaccine recipients
Timeframe: At months 7 and 13
Interventions:
Enrollment:
7460
Primary completion date:
1999-30-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bernstein D et al. (2005) Safety and Immunogenicity of Glycoprotein D—Adjuvant Genital Herpes Vaccine. Clin Infect Dis. 40(9):1271-1281.
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
Prophylaxis for herpes simplex
Product
Herpes Simplex Vaccine
Collaborators
Not applicable
Study date(s)
October 1996 to April 1999
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Yes
- 18 years of age and over 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:
- 18 years of age and over at the time of first vaccination
- Written informed consent
- Females of childbearing potential must have a negative pregnancy test at enrollment and prior to each vaccination and be using an accepted method of birth control
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 drug or vaccine concurrent with this study or during the period beginning 30 days prior to entry into the study or 5 half-lives of the drug
- Recent history of alcoholism or drug abuse
- Recent clinical history or evidence of significant hepatic disease
- History of a current acute or chronic auto immune 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)
Location
GSK Clinical Trials Call Center
Montreal, Quebec, Canada, H2L 4C7
Status
Study Complete
Showing 1 - 6 of 47 Results
Study documents
Scientific result summary
Available language(s): English
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
1999-30-04
Actual study completion date
1999-30-04
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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