HIV InfectionNCT00789789
Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials
An observational study of HIV Infection and HIV Seronegativity, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infection, HIV Seronegativity
- How many people
- 488 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2008to 30 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy volunteers.
Who may be able to join
- 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
Who cannot join
- volunteers not covered by Health Insurance
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- HIV Infection, HIV Seronegativity
- Keywords
- Cohort, HIV uninfected volunteers, HIV preventive vaccine, Long term safety
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: once a year
Secondary outcomes (3)
Evaluation of HIV serologic status by two ELISA tests and Western blot test ( only if ELISA is positive).
Measured: once a year
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.
Measured: once a year
Incidence of HIV infection (frequency, description of contamination).
Measured: once a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2016
- Study completion30 Sep 2016
Why it stopped: stopped prematurely due to the absence of safety signal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Odile LAUNAY, MD, PhD, Principal investigator, CIC Cochin Pasteur, Hôpital Cochin, Paris, FranceLaurence MEYER, MD, PhD, Study chair, INSERM SC-10-US019, Villejuif, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789789
- Sponsor's protocol ID
- 2007-002219-14
- Other IDs
- ANRS COV1 COHVAC
- Status last verified
- May 2017
- First submitted
- 10 Nov 2008
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials
- ClinicalTrials.gov ID
- NCT00789789
- Acronym / sponsor ID
- 2007-002219-14
- Conditions
- HIV Infection, HIV Seronegativity
- Keywords
- Cohort, HIV uninfected volunteers, HIV preventive vaccine, Long term safety
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: stopped prematurely due to the absence of safety signal
- Enrolment
- 488 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Dec 2008
- Primary completion
- Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy volunteers.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- volunteers not covered by Health Insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Evaluation of HIV serologic status by two ELISA tests and Western blot test ( only if ELISA is positive).
Time frame: once a year
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
Incidence of HIV infection (frequency, description of contamination).
Time frame: once a year
Results and safety
The study was stopped early (reason given: stopped prematurely due to the absence of safety signal). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
Related trials for HIV Infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Odile LAUNAY, MD, PhD principal investigator
CIC Cochin Pasteur, Hôpital Cochin, Paris, France
Laurence MEYER, MD, PhD study chair
INSERM SC-10-US019, Villejuif, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection and HIV Seronegativity, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: stopped prematurely due to the absence of safety signal). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.