Last updated: 11/04/2018 00:44:47
Humoral and cellular immune response of herpes simplex (gD) candidate vaccines from 2 different cell lines
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Study to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control
Trial description: The purpose of the study is to compare, in healthy HSV seronegative and HSV seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gD from two different cell lines and using gD-Alum as control.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA)
Timeframe: After the second and third doses of each vaccine
To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon)
Timeframe: After the second and third dose of each vaccine formulation
To evaluate, in initially seronegative subjects and in initially seropositive subjects, the incidence and intensity of solicited local and general signs and symptoms
Timeframe: During 3 days after each dose of each vaccine
To evaluate in initially seropositive subjects, the GMT and the seropositivity rate of anti-gD2 antibodies (ELISA) and of anti-HSV-2 neutralizing antibodies
Timeframe: After 2 and 3 doses of vaccines
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Biological/vaccine: Herpes simplex virus containing gD-Alum
Enrollment:
130
Observational study model:
Not applicable
Primary completion date:
1997-31-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Prophylaxis herpes simplex
Product
Herpes Simplex Vaccine
Collaborators
Not applicable
Study date(s)
September 1995 to January 1997
Type
Interventional
Phase
1/2
Participation criteria
Sex
Female & Male
Age
18 - 45 Years
Accepts healthy volunteers
Yes
- Between 18 and 45 years of age
- Written informed consent
- Any previous vaccination against Herpes simplex.
- Any previous administration of MPL.
Inclusion and exclusion criteria
Inclusion criteria:
- Between 18 and 45 years of age
- Written informed consent
- Female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course
- Serology: Groups 1, 3, 4 and 5: HSV-1 AND HSV-2 seronegative (by gD2 ELISA); Group 2: HSV seropositive by gD2 ELISA before entry
Exclusion criteria:
- Any previous vaccination against Herpes simplex.
- Any previous administration of MPL.
- Pregnancy or lactation.
- Patient is immuno-compromised or is receiving immuno-modifying therapy of any kind.
- Clinical signs of acute or febrile illness at the time of entry into the study.
- Any administration of immunoglobulins during the vaccination course or within one month of vaccination.
- Any vaccination within one week of study vaccination.
- Previous known hypersensitivity to vaccination or to any component of the vaccine.
- Simultaneous participation in any other clinical trial with an investigational drug or vaccine. Subjects currently in a follow-up period of a vaccine study can be included.
- Recent history of alcoholism or drug abuse (within the past 6 months).
- Life-threatening or serious cardiac (NYHA grades III-IV), gastrointestinal, hepatic, renal, hematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.
Trial location(s)
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
Completed
Actual primary completion date
1997-31-01
Actual study completion date
1997-31-01
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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