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Study to Compare the Immunogenicity and Safety of Two HIV Preventive Vaccinations in Healthy Volunteers — EV03/ANRSVAC20  

HIV Infections Clinical Trial

Official title:
A Phase I/II 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

Clinical Trial 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.

Clinical Trial Description

Methods: randomised phase I/II 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 CD8/CD4+ 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

Patient's participation duration: 78 weeks

Study duration: 27 months ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00490074
Study type Interventional
Source French National Agency for Research on AIDS and Viral Hepatitis
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 2007
Completion date October 2009
View Details
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