Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT00789789
First received: November 10, 2008
Last updated: July 7, 2014
Last verified: September 2012

November 10, 2008
July 7, 2014
December 2008
December 2017   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00789789 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood specimen collection (serum, plasma and whole blood)

Non-Probability Sample

healthy volunteers.

  • HIV Infection
  • HIV Seronegativity
Not Provided
1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
488
December 2017
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy volunteers of the "ANRS volunteer network" who have received at least one dose of a vaccine candidate in a HIV preventive clinical trial.
  • volunteers who have signed an informed consent

Exclusion Criteria:

  • volunteers not covered by Health Insurance
Both
18 Years and older
Yes
Contact: Corinne DESAINT, PhD 33 1 45 59 51 68 corinne.desaint@inserm.fr
France
 
NCT00789789
2007-002219-14, ANRS COV1 COHVAC
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Not Provided
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
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP