Ignite Creation Date:
2024-05-05 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00751595
Status:
COMPLETED
Last Update Posted:
2016-03-04
First Post:
2008-09-11
Brief Title:
Immunogenicity and Safety Trial of the HIV-1 Tat Vaccine
Sponsor:
Barbara Ensoli MD
Organization:
Istituto Superiore di SanitÃ
Study Overview
Official Title:
A Phase II Randomized Open Label Immunogenicity and Safety Trial of the Vaccine Based on the Recombinant Biologically Active HIV-1 Tat Protein in Anti-Tat Negative HIV-1 Infected HAART-treated Adult Subjects
Status:
COMPLETED
Status Verified Date:
2016-03
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:
ISS T-002
Brief Summary:
The study is a randomized open label phase II clinical trial directed at evaluating the immunogenicity as a primary end-point and the safety as a secondary end-point of the recombinant HIV-1 Tat vaccine in HIV-1 infected adult subjects anti-Tat antibody negative HAART-treated with chronic suppressed HIV-1 infection CD4 T cell counts 200 cellsmicroliter levels of plasma viremia 50 copiesml in the last 6 months prior to the screening and without a history of virologic rebound The immunogenicity of 3 or 5 immunizations of the two different vaccine doses 75 and 30 micrograms of the Tat vaccine has been evaluated
Detailed Description:
This phase II clinical trial was directed at evaluating the immunogenicity and the safety of the HIV-1 Tat protein-based vaccine Anti-Tat antibody negative HIV-1 positive subjects treated successfully with HAART have been screened and recruited for a 48-weeks study including a period of 16 or 8 weeks treatment phase and a period of 32 or 40 weeks follow-up phase in arm A or Arm B respectively One hundred sixty-eight subjects have been randomized 1111 to one of the 2 arms Arm A and Arm B and each arm has been divided in the following groups
Arm A - Group I 5 immunizations with Tat 75 microg at weeks 0 4 8 12 16 Arm A - Group II 5 immunizations with Tat 30 microg at weeks 0 4 8 12 16 Arm B - Group I 3 immunizations with Tat 75 microg at weeks 0 4 8 Arm B - Group II 3 immunizations with Tat 30 microg at weeks 0 4 8
Four vaccination regimens have been tested by intradermal administration of the Tat vaccine at two different doses 75 microg or 30 microg in 5 or 3 immunizations
Arm A - Group I 5 immunizations with Tat 75 microg at weeks 0 4 8 12 16 Arm A - Group II 5 immunizations with Tat 30 microg at weeks 0 4 8 12 16 Arm B - Group I 3 immunizations with Tat 75 microg at weeks 0 4 8 Arm B - Group II 3 immunizations with Tat 30 microg at weeks 0 4 8
Four vaccination regimens have been tested by intradermal administration of the Tat vaccine at two different doses 75 microg or 30 microg in 5 or 3 immunizations
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