Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00490074
Status:
COMPLETED
Last Update Posted:
2009-11-26
First Post:
2007-06-21
Brief Title:
Study to Compare the Immunogenicity and Safety of Two HIV Preventive Vaccinations in Healthy Volunteers
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
A Phase III Trial to Compare the Immunogenicity and Safety of 3 DNA C Prime Followed by 1 NYVAC C Boost to 2 DNA C Prime Followed by 2 NYVAC C Boost
Status:
COMPLETED
Status Verified Date:
2009-11
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:
EV03ANRSVAC20
Brief Summary:
The purpose of the trial is to evaluate the effect upon immune system of two regimens of preventive HIV vaccination in healthy adult volunteers Volunteers will be vaccinated by DNA-C and NYVAC-C vaccines and the immune changes will be assessed as well as safety of the vaccines Volunteers will be followed during 72 weeks
Detailed Description:
Methods randomised phase III international trial with a parallel group design open to participants and investigators but blind to laboratory personnel in healthy volunteers
Vaccines strategies 70 volunteers will receive 3 DNA-C vaccinations and 1 NYVAC-C vaccination 70 volunteers will receive 2 DNA-C vaccinations and 2 NYVAC-C vaccination
DNA-C 2x2ml intra muscular in right and left vastus lateralis NYVAC-C 1 ml intramuscular in non-dominant deltoid
Main outcome
1 the presence of CD8CD4 T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays
in response to env plus at least one of the gag pol nef peptide pools
at weeks 26 or 28
2 the safety parameters
Secondary outcomes
cellular responses
antibody responses
all grade 1 and 2 adverse events
all events including those considered unrelated
Sample size 140 volunteers
Enrollment period 9 months
Patients participation duration 78 weeks
Study duration 27 months
Vaccines strategies 70 volunteers will receive 3 DNA-C vaccinations and 1 NYVAC-C vaccination 70 volunteers will receive 2 DNA-C vaccinations and 2 NYVAC-C vaccination
DNA-C 2x2ml intra muscular in right and left vastus lateralis NYVAC-C 1 ml intramuscular in non-dominant deltoid
Main outcome
1 the presence of CD8CD4 T cell responses defined according to internationally agreed criteria for evaluation of IFNgamma ELISPOT assays
in response to env plus at least one of the gag pol nef peptide pools
at weeks 26 or 28
2 the safety parameters
Secondary outcomes
cellular responses
antibody responses
all grade 1 and 2 adverse events
all events including those considered unrelated
Sample size 140 volunteers
Enrollment period 9 months
Patients participation duration 78 weeks
Study duration 27 months
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 |
|---|---|---|---|
| EV03ANRSVAC20 | None | None | None |