Ignite Creation Date:
2024-05-05 @ 11:53 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01441193
Status:
TERMINATED
Last Update Posted:
2016-03-04
First Post:
2011-09-26
Brief Title:
A Phase I Safety and Immunogenicity Preventive Vaccine Trial Based on the HIV-1 Tat and V2-deleted Env Proteins ISS P-002
Sponsor:
Barbara Ensoli MD
Organization:
Istituto Superiore di Sanità
Study Overview
Official Title:
A Phase I Open Label Safety and Immunogenicity Vaccine Trial Based on the Association of Recombinant HIV-1 Biologically Active Tat and V2-deleted Env Proteins in HIV Uninfected Healthy Adult Volunteers
Status:
TERMINATED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrollments were suspended due to delta-V2 Env unavailability following the EMACHMPBWP5348982008 guideline not allowing the use of a retest date
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase I study was directed at evaluating the safety profile and the immunogenicity of the vaccination with recombinant HIV-1 Tat and V2-deleted Env delta-V2 Env proteins administered in association in healthy immunologically competent adults compared to delta-V2 Env or Tat alone
Detailed Description:
Since the inexorable spreading of HIV pandemic is unabated the urgency of designing an effective safe inexpensive and easily administrable vaccine to protect people from HIV andor AIDS is an absolute priority Considering the array of functions sequentially exerted by the regulatory and the structural gene products in supporting the setting of a primary HIV infection it is expected that vaccines combining early and late viral products combined vaccines should be superior to the single antigens approaches since they target multiple viral proteins which are necessary at different key steps of the virus life cycle including cell-to-cell virus transmission and systemic virus propagation A combined vaccine strategy based on the early regulatory protein Tat in association with the late structural protein Env modified to increase its immunogenicity delta-V2Env has been evaluated in pre-clinical studies in both small animals and monkeys The results of these studies indicated that the combination of Tat with delta-V2Env is superior in inducing specific immune responses against both Tat and delta-V2Env antigens and in protecting or containing virus replication more efficiently than vaccination with the single antigens alone confirming that these proteins represent optimal co-antigens for a combined vaccine strategy
This study was a multicentric open label randomized phase I trial directed to qualify the safety and the immunogenicity of the vaccine based on the association of HIV-1 biologically active Tat and oligomeric ΔV2 Env proteins in healthy immunologically competent adult volunteers compared to the single compounds Tat and delta-V2 Env proteins either in association or as single compounds were administered by a prime-boost regimen consisting of 3 intradermal priming doses followed by 2 intramuscular boosting injections Of note phase I trials have already been successfully conducted with the 2 single components at the doses proposed in this trial in healthy individuals
This study was a multicentric open label randomized phase I trial directed to qualify the safety and the immunogenicity of the vaccine based on the association of HIV-1 biologically active Tat and oligomeric ΔV2 Env proteins in healthy immunologically competent adult volunteers compared to the single compounds Tat and delta-V2 Env proteins either in association or as single compounds were administered by a prime-boost regimen consisting of 3 intradermal priming doses followed by 2 intramuscular boosting injections Of note phase I trials have already been successfully conducted with the 2 single components at the doses proposed in this trial in healthy individuals
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