NCT00490074

Study to Compare the Immunogenicity and Safety of Two HIV Preventive Vaccinations in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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 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

Conditions

• HIV Infections

Interventions

Type	Name	Description
BIOLOGICAL	DNA-C	1.0mg per ml of DNA HIV-C vaccine 2x2 ml IM
BIOLOGICAL	NYVAC-C	NYVAC-C 1 ml IM

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-12-01
• Completion: 2009-10-01
• First posted: 2007-06-22
• Last updated: 2026-04-08

Locations

2 sites across 2 countries: France, Switzerland