Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials
This cohort study should provide an exhaustive overview on long-term safety of various preventive HIV-vaccines administered in phase I and II clinical trials to healthy volunteers of the ANRS network.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials|
- Description of severe health events (grade 3-4), as well as neurological, ophtalmological, and immunological events (any grade), starting from the first injection of a HIV candidate vaccine. [ Time Frame: once a year ] [ Designated as safety issue: Yes ]
- Evaluation of HIV serologic status by two ELISA tests and Western blot test ( only if ELISA is positive). [ Time Frame: once a year ] [ Designated as safety issue: No ]
- Evaluation of psycho-behavioral consequences, associated to participation in a HIV preventive trial, on entourage, familial, professional and social relations, with a self-questionnaire and an interview with a clinician. [ Time Frame: once a year ] [ Designated as safety issue: No ]
- Incidence of HIV infection (frequency, description of contamination). [ Time Frame: once a year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood specimen collection (serum, plasma and whole blood)
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Since 1992, 16 phase I and II clinical trials have been performed by the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) evaluating the safety of several HIV-1 vaccine candidates and their capacity to induce immune responses. The ANRS program has evaluated a recombinant HIV-1 envelope protein Rgp-160, canarypox ALVAC vectors, and mixtures of lipopeptides whose sequences represent CTL-epitopes of HIV-1 Gag, Pol and Nef proteins. Most of them have been administered intramuscularly but recently, mucosal immunization and intradermal route were used. Previously compiled in a published meta-analysis, safety studies were restricted to the duration of the trials.
ANRS establishes a cohort study in order to describe the long-term safety of preventive HIV-vaccines administered in phase I and II clinical trials to healthy volunteers of the "ANRS volunteer-network" in France and to gather clinical and biological data in a database and blood specimen collection which could be analysed in case of a long-term safety issue in ANRS vaccine trials or if pertinent, in other HIV vaccine trials ANRS COV1-COHVAC is a prospective, multicentric cohort study composed of participants in preventive HIV-vaccines phase I and II trials. All ANRS volunteers who ever received one dose of a candidate vaccine are eligible and those who are going to complete their participation to a clinical trial during the cohort study time.
The ANRS COV1-COHVAC project relies on a long-term follow-up of the cohort (at least 7 years after the end of the vaccine trial), that includes the retrospective and prospective collection of medical and biological data [severe health events (grade 3-4), as well as neurological, ophtalmological, and immunological events (any grade), starting from the first injection of a candidate vaccine, are recorded], blood specimen collections and psycho-behavioral evaluations (self-questionnaires and interviews) in order to collect data about consequences of participation and experience of possible HIV vaccine-induced seropositivity in such trials.
Of the ANRS "volunteer-network", 206 participants have been involved in the early trials and are actually eligible to participate in this cohort. Altogether with the more recent studies completed or in progress, the cohort will comprise at least 400 individuals in 2009.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789789
|Contact: Corinne DESAINT, PhD||33 1 45 59 51 firstname.lastname@example.org|
|CIC de Vaccinologie Cochin Pasteur, hôpital Cochin||Recruiting|
|Paris, France, 75679|
|Contact: Odile LAUNAY, MD, PhD 33 1 58 41 28 58 email@example.com|
|Principal Investigator: Odile LAUNAY, MD|
|Principal Investigator:||Odile LAUNAY, MD, PhD||CIC de Vaccinologie Cochin Pasteur, Hôpital Cochin, Paris, France|
|Study Chair:||Jean-Pierre ABOULKER, MD||INSERM SC-10, Villejuif, France|