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
  Purpose

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.


Condition
HIV Infection
HIV Seronegativity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 488
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)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

healthy volunteers.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789789

Contacts
Contact: Corinne DESAINT, PhD 33 1 45 59 51 68 corinne.desaint@inserm.fr

Locations
France
CIC de Vaccinologie Cochin Pasteur, hôpital Cochin Recruiting
Paris, France, 75679
Contact: Odile LAUNAY, MD, PhD    33 1 58 41 28 58    odile.launay@cch.aphp.fr   
Principal Investigator: Odile LAUNAY, MD         
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Investigators
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
  More Information

No publications provided

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     History of Changes
Other Study ID Numbers: 2007-002219-14, ANRS COV1 COHVAC
Study First Received: November 10, 2008
Last Updated: July 7, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
Cohort
HIV uninfected volunteers
HIV preventive vaccine
Long term safety

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 21, 2014