HIV InfectionsNCT05450770
Immunity to Yellow Fever in HIV-infected Patients 10 Years After a Primary Anti-yellow Fever Vaccination
A study testing Yellow fever vaccination (STAMARIL) in people with HIV Infections and Yellow Fever, run by ANRS, Emerging Infectious Diseases.
Trial summary
ANRS 0146s NovaaTen study aims to determine the vaccine responses in the participants of the ANRS EP46 Novaa trial 10 years after a primary anti-yellow fever vaccination Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Yellow Fever
- What is being tested?
- Yellow fever vaccination (STAMARIL)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Nov 2024
- Phase
- Interventional
- 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
Who may be able to join
- Subjects included in the ANRS EP 46 NOVAA trial:
- 40 HIV positive subjects from consultations for infectious diseases and travel medicine centers at Saint-Louis, Cochin-Pasteur and Bichat hospitals (on HAART for at least one year and not modified in the 3 months preceding the pre-inclusion visit, CD4 > 350/mm3 and a viral load <50 copies / mL for at least 6 months).
- 20 HIV negative subjects from the consultation of travelers from Saint-Louis, Bichat and Cochin-Pasteur hospitals.
- Subjects agreeing to be monitored according to the terms of the protocol.
- Subjects affiliated to a Social Security scheme or beneficiaries of such a scheme.
- Signature of informed consent.
Who cannot join
- Non-volunteers for the 10-year follow-up
- Subject under curatorship, guardianship or safeguard of justice.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Yellow Fever Vaccine Immunity in HIV Infected Patients: Studies of Immunological Responses at 10 Years (ANRS 0146s NovaaTen)
ANRS 0146s NovaaTen study aims to determine the vaccine responses in the participants of the ANRS EP46 Novaa trial 10 years after a primary anti-yellow fever vaccination
Read the detailed description
The vaccine responses will be determined with the measurement of the neutralizing antibody titers using the neutralization tests PRNT and Pseudo type ACN 400 to M120 (ten years) in the participants of the ANRS EP 46 NOVAA trial, VIH+ and controls naïve to previous vaccination ten years after a primary anti-yellow fever vaccination.
- Conditions
- HIV Infections, Yellow Fever
- Being tested
- Yellow fever vaccination (STAMARIL)
- Medical subject headings
- HIV Infections, Yellow Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yellow fever vaccination (STAMARIL)Biological
Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects
| Study group | Role | What they receive |
|---|---|---|
| HIV+ GROUP | Active comparator | Subjects included in the ANRS EP 46 NOVAA trial:
• 40 HIV positive subjects from consultations for infectious diseases and travel medicine centers at Saint-Louis, Cochin-Pasteur and Bichat hospitals (on HAART for at least one year and not modified in the 3 months preceding the pre-inclusion visit, CD4 > 350/mm3 and a viral load <50 copies / mL for at least 6 months). Receives: Biological: Yellow fever vaccination (STAMARIL) |
| HIV- GROUP | Other | Subjects included in the ANRS EP 46 NOVAA trial:
• 20 HIV negative subjects from the consultation of travelers from Saint-Louis, Bichat and Cochin-Pasteur hospitals. Receives: Biological: Yellow fever vaccination (STAMARIL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immuno-virologic criterion
At Months 120 (10years), the antibody titers of neutralizers by PRNT (Plaque reduction neutralization test) and pseudotypes will be determined
Measured: At Months 120 (10years)
Secondary outcomes (1)
Predicting a sustained vaccine response 10 years later.
To study the effect of clinical and biological factors in HIV+ patients (collection of data on: age; clinical examination; heart rate; weight; body temperature; blood pressure; CD4, CD8 and the CD4/CD8 ratio; the nadir and zenith of CD4; the duration of antiretroviral treatment; the duration of HIV infection) on the PRNT titers transformed into logarithm and the percentages of neutralization at ten years, uni and multivariate regressions are used.
Measured: At Months 120 (10years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Category 2, multi-centric intervention research comparing 2 parallel groups of 40 HIV + subjects and 20 HIV- subjects included in the ANRS EP46 NOVAA trial.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Saint-Louis Hospital, Paris, France, Bichat Hospital, Hôpital Cochin
- Responsible party
- Sponsor
- Investigators
- Nathalie COLIN de VERDIERE, Study director, Maladies Infectieuses St Louis ParisOdile LAUNAY, Principal investigator, CIC Cochin ParisJade GHOSN, Principal investigator, Hôpital Bichat Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450770
- Sponsor's protocol ID
- ANRS 0146s NovaaTen
- Status last verified
- Jul 2024
- First submitted
- 14 Jun 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Yellow Fever Vaccine Immunity in HIV Infected Patients: Studies of Immunological Responses at 10 Years (ANRS 0146s NovaaTen)
- ClinicalTrials.gov ID
- NCT05450770
- Acronym / sponsor ID
- ANRS 0146s NovaaTen
- Conditions
- HIV Infections, Yellow Fever
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Saint-Louis Hospital, Paris, France, Bichat Hospital, Hôpital Cochin
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 11 Jul 2022 (actual)
- 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.
ANRS 0146s NovaaTen study aims to determine the vaccine responses in the participants of the ANRS EP46 Novaa trial 10 years after a primary anti-yellow fever vaccination
Detailed description
The vaccine responses will be determined with the measurement of the neutralizing antibody titers using the neutralization tests PRNT and Pseudo type ACN 400 to M120 (ten years) in the participants of the ANRS EP 46 NOVAA trial, VIH+ and controls naïve to previous vaccination ten years after a primary anti-yellow fever vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Category 2, multi-centric intervention research comparing 2 parallel groups of 40 HIV + subjects and 20 HIV- subjects included in the ANRS EP46 NOVAA trial.
| Arm | Type | Receives |
|---|---|---|
| HIV+ GROUP | Active comparator | Biological: Yellow fever vaccination (STAMARIL)Subjects included in the ANRS EP 46 NOVAA trial: • 40 HIV positive subjects from consultations for infectious diseases and travel medicine centers at Saint-Louis, Cochin-Pasteur and Bichat hospitals (on HAART for at least one year and not modified in the 3 months preceding the pre-inclusion visit, CD4 > 350/mm3 and a viral load <50 copies / mL for at least 6 months). |
| HIV- GROUP | Other | Biological: Yellow fever vaccination (STAMARIL)Subjects included in the ANRS EP 46 NOVAA trial: • 20 HIV negative subjects from the consultation of travelers from Saint-Louis, Bichat and Cochin-Pasteur hospitals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects included in the ANRS EP 46 NOVAA trial:
Key exclusion criteria (2 listed)
- Non-volunteers for the 10-year follow-up
- Subject under curatorship, guardianship or safeguard of justice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yellow fever vaccination (STAMARIL)Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects | Biological | HIV+ GROUP, HIV- GROUP |
Primary outcome
Immuno-virologic criterion
Time frame: At Months 120 (10years)
At Months 120 (10years), the antibody titers of neutralizers by PRNT (Plaque reduction neutralization test) and pseudotypes will be determined
1 secondary outcome
Predicting a sustained vaccine response 10 years later.
Time frame: At Months 120 (10years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
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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.
Nathalie COLIN de VERDIERE study director
Maladies Infectieuses St Louis Paris
Odile LAUNAY principal investigator
CIC Cochin Paris
Jade GHOSN principal investigator
Hôpital Bichat Paris
Questions about this trial
What is this clinical trial studying?
A study testing Yellow fever vaccination (STAMARIL) in people with HIV Infections and Yellow Fever, run by ANRS, Emerging Infectious Diseases.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie COLIN DE VERDIERE (01.42.02.66.45, nathalie.colin-de-verdiere@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immuno-virologic criterion (time frame: At Months 120 (10years)). 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 30 Jul 2024.