Ignite Creation Date:
2024-05-06 @ 12:08 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01496989
Status:
COMPLETED
Last Update Posted:
2013-09-02
First Post:
2011-12-19
Brief Title:
Safety and Immunogenicity Study of HIV-MAG Vaccine - IL-12 and Ad35-GRINENV in HIV-uninfected Volunteers
Sponsor:
International AIDS Vaccine Initiative
Organization:
International AIDS Vaccine Initiative
Study Overview
Official Title:
A Phase 1 Double-Blind Randomized Placebo-Controlled Trial to Evaluate Safety and Immunogenicity of a Multiantigen HIV HIV-MAG pDNA Vaccine With or Without Human IL-12 pDNA GENEVAX IL-12 and Ad35-GRINENV Vaccine in HIV-Uninfected Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2013-08
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:
The purpose of this study is to evaluate the safety tolerability and immunogenicity of multiantigen HIV HIV-MAG plasmid DNA pDNA vaccine co-administered with recombinant human IL-12 pDNA GENEVAX IL-12 followed or preceded by recombinant Ad35-GRINENV HIV vaccine in low-risk for HIV-uninfected healthy adults
Detailed Description:
The study is a randomized double-blind placebo-controlled trial assessing the safety and tolerability of HIV-MAG with or without co-administered GENEVAX IL-12 given intramuscularly by in vivo electroporation IMEP using the Ichor Medical Systems TriGrid Delivery System TDS-IM followed by Ad35-GRINENV in each of four different regimens An additional group will evaluate the safety and tolerability of Ad35-GRINENV followed by HIV-MAG with co-administered GENEVAX IL-12 given intramuscularly by in vivo electroporation IMEP using the Ichor Medical Systems TriGrid Delivery System TDS-IM
Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the first vaccine administration It is anticipated that it will take approximately 3 months to enrol the study Approximately 75 volunteers 60 vaccine15 placebo recipients will be included in the study
Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the first vaccine administration It is anticipated that it will take approximately 3 months to enrol the study Approximately 75 volunteers 60 vaccine15 placebo recipients will be included in the study
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