Humoral and Cellular Immune Response of Herpes Simplex (gD) Candidate Vaccines From 2 Different Cell Lines
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00698490
First received: June 13, 2008
Last updated: June 16, 2008
Last verified: June 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prophylaxis Herpes Simplex |
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141 Biological: Herpes simplex virus containing gD-Alum |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- To evaluate in initially HSV-seronegative subjects the GMT's and the seroconversion rates of anti-gD2 antibodies (ELISA) [ Time Frame: After the second and third doses of each vaccine ]
- To evaluate in initially HSV-seronegative subjects, the GMT and the seropositivity rate of anti-HSV-2 neutralizing antibodies
- To evaluate the cell-mediated immune (CMI) response (lymphoproliferation, secretion of interleukin 2 and γ interferon) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: After 2 and 3 doses of vaccines ]
| Enrollment: | 130 |
| Study Start Date: | August 1995 |
| Study Completion Date: | January 1997 |
| Primary Completion Date: | January 1997 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A
HSV-seronegative subjects
|
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Intramuscular injection, 3 doses, 2 different formulations
|
|
Experimental: Group B
HSV-seropositive subjects
|
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Intramuscular injection, 3 doses, 2 different formulations
|
|
Experimental: Group C
HSV-seronegative subjects
|
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Intramuscular injection, 3 doses, 2 different formulations
|
|
Experimental: Group D
HSV-seronegative subjects
|
Biological: Adjuvanted herpes simplex (gD) candidate vaccine GSK 208141
Intramuscular injection, 3 doses, 2 different formulations
|
|
Experimental: Group E
HSV-seronegative subjects
|
Biological: Herpes simplex virus containing gD-Alum
Intramuscular injection, 3 doses
|
Detailed Description:
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Isabelle Harpigny, GSK |
| ClinicalTrials.gov Identifier: | NCT00698490 History of Changes |
| Other Study ID Numbers: | 208141/015 |
| Study First Received: | June 13, 2008 |
| Last Updated: | June 16, 2008 |
| Health Authority: | Belgium: Institutional Review Board |
Keywords provided by GlaxoSmithKline:
|
Herpes simplex Herpes simplex candidate vaccine |
Additional relevant MeSH terms:
|
Herpes Simplex Herpesviridae Infections DNA Virus Infections Virus Diseases |
Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013