Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00117429
Status:
COMPLETED
Last Update Posted:
2010-02-15
First Post:
2005-06-30
Brief Title:
Study of the HIV gp120NefTatAS02A Vaccine to Treat Individuals With Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy HAART
Sponsor:
Marcus Altfeld MD PhD
Organization:
Marcus Altfeld MD PhD
Study Overview
Official Title:
A Phase I Randomized Double-Blind Clinical Trial of the HIV gp120NefTatAS02A Vaccine Candidate in Subjects With Well-Controlled Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy HAART
Status:
COMPLETED
Status Verified Date:
2010-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test the safety and immunogenicity of the gp120NefTatAS02A vaccine candidate in individuals with chronic HIV-1 infection successfully treated with HAART The rationale for this study is based on previous scientific experiments including data indicating that this vaccine can elicit strong HIV-1-specific T cell immune responses in humans and monkeys and lead to a retardation of HIV-1 disease progression in animal models of HIV-1 infection
The HIV vaccine to be administered during this study consists of three recombinant HIV clade B viral antigens the envelope glycoprotein gp120 and two regulatory proteins Nef and TatThe antigens are formulated in a proprietary adjuvant AS02A comprised of two immunostimulants in an oil-in-water emulsion gp120NefTatAS02A The vaccine and the adjuvant are manufactured and provided for the study by GlaxoSmithKline Biologicals Rixensart Belgium The drugs will be given by intramuscular IM injection at a standard dose of 20 mg together with 05 ml of the AS02A adjuvant
Twenty HIV-1 infected individuals will be randomly enrolled into three different study groups receiving either the gp120NefTatAS02A vaccine 10 individuals the AS02A adjuvant alone 5 individuals or a placebo 5 individuals After obtaining informed consent subjects will have a history and physical exam performed and have laboratory tests to confirm they meet all inclusion and exclusion entry criteria Women of childbearing potential will have a pregnancy test prior to each injection of the investigational product Injections with vaccine adjuvant alone or placebo will then be performed at weeks 0 4 and 12 Study participants will undergo close monitoring after each vaccination Blood samples will be obtained for immunological assays at study baseline 2 times and weeks 2 4 6 12 14 24 and 48 All patients will maintain their antiretroviral treatment regimen during the entire study period
The HIV vaccine to be administered during this study consists of three recombinant HIV clade B viral antigens the envelope glycoprotein gp120 and two regulatory proteins Nef and TatThe antigens are formulated in a proprietary adjuvant AS02A comprised of two immunostimulants in an oil-in-water emulsion gp120NefTatAS02A The vaccine and the adjuvant are manufactured and provided for the study by GlaxoSmithKline Biologicals Rixensart Belgium The drugs will be given by intramuscular IM injection at a standard dose of 20 mg together with 05 ml of the AS02A adjuvant
Twenty HIV-1 infected individuals will be randomly enrolled into three different study groups receiving either the gp120NefTatAS02A vaccine 10 individuals the AS02A adjuvant alone 5 individuals or a placebo 5 individuals After obtaining informed consent subjects will have a history and physical exam performed and have laboratory tests to confirm they meet all inclusion and exclusion entry criteria Women of childbearing potential will have a pregnancy test prior to each injection of the investigational product Injections with vaccine adjuvant alone or placebo will then be performed at weeks 0 4 and 12 Study participants will undergo close monitoring after each vaccination Blood samples will be obtained for immunological assays at study baseline 2 times and weeks 2 4 6 12 14 24 and 48 All patients will maintain their antiretroviral treatment regimen during the entire study period
Detailed Description:
DESIGN This study is a randomized double blind clinical trial of the gp120NefTatAS02A vaccine in individuals with well-controlled chronic HIV-1 infection who have been successfully treated with highly active antiretroviral therapy HAART The adjuvanted protein vaccine candidate consists of three recombinant viral antigens the envelope glycoprotein gp120 and two regulatory proteins Nef and Tat The latter are expressed as one recombinant fusion protein NefTat The antigens are formulated in the proprietary AS02A adjuvant The goal of this trial is to assess the safety and immunogenicity of the gp120NefTatAS02A vaccine in HIV-1-infected individuals
DURATION 48 weeks
SAMPLE SIZE 20 subjects
POPULATION Subjects with chronic HIV-1 infection receiving highly active antiretroviral therapy HAART with HIV RNA levels 50 copiesmL on at least two measurements in the previous 6 months and a CD4 T cell count 400 cellsmm3 within 45 days of study entry will be eligible for this study
REGIMEN Enrolled patients will be randomized to receive either the vaccine gp120NefTatAS02A 10 individuals the AS02A adjuvant only 5 individuals or a placebo 5 individuals Injections will be administered IM at weeks 0 4 and 12
OBJECTIVES The two primary objectives of this study are
to evaluate the safety and tolerability of the gp120NefTatAS02A vaccine in individuals with well-controlled chronic HIV-1 infection on HAART and
to evaluate the cell-mediated immune response IL-2 secreting CD4 T cells to at least one vaccinal antigen induced by the vaccine-adjuvant combination in individuals with chronic HIV-1 infection on successful HAART at two weeks after the third vaccination
ENDPOINTS The two co-primary study endpoints will be
the occurrence intensity and relationship of any local and general signs and symptoms during a 7-day follow-up period after each vaccination primary safety endpoint and
the changes in the frequency of IL-2 secreting CD4 T cells in response to at least one vaccinal antigen primary immunogenicity endpoint in the three different patient categories assessed two weeks after the third vaccination
DURATION 48 weeks
SAMPLE SIZE 20 subjects
POPULATION Subjects with chronic HIV-1 infection receiving highly active antiretroviral therapy HAART with HIV RNA levels 50 copiesmL on at least two measurements in the previous 6 months and a CD4 T cell count 400 cellsmm3 within 45 days of study entry will be eligible for this study
REGIMEN Enrolled patients will be randomized to receive either the vaccine gp120NefTatAS02A 10 individuals the AS02A adjuvant only 5 individuals or a placebo 5 individuals Injections will be administered IM at weeks 0 4 and 12
OBJECTIVES The two primary objectives of this study are
to evaluate the safety and tolerability of the gp120NefTatAS02A vaccine in individuals with well-controlled chronic HIV-1 infection on HAART and
to evaluate the cell-mediated immune response IL-2 secreting CD4 T cells to at least one vaccinal antigen induced by the vaccine-adjuvant combination in individuals with chronic HIV-1 infection on successful HAART at two weeks after the third vaccination
ENDPOINTS The two co-primary study endpoints will be
the occurrence intensity and relationship of any local and general signs and symptoms during a 7-day follow-up period after each vaccination primary safety endpoint and
the changes in the frequency of IL-2 secreting CD4 T cells in response to at least one vaccinal antigen primary immunogenicity endpoint in the three different patient categories assessed two weeks after the third vaccination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GSK TH-HIV-007 | None | None | None |