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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05450770
Other study ID # ANRS 0146s NovaaTen
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date November 1, 2024

Study information

Verified date November 2023
Source ANRS, Emerging Infectious Diseases
Contact Nathalie COLIN DE VERDIERE
Phone 01.42.02.66.45
Email nathalie.colin-de-verdiere@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date November 1, 2024
Est. primary completion date November 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Non-volunteers for the 10-year follow-up - Subject under curatorship, guardianship or safeguard of justice.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects

Locations

Country Name City State
n/a

Sponsors (4)

Lead Sponsor Collaborator
ANRS, Emerging Infectious Diseases Bichat Hospital, Hôpital Cochin, Saint-Louis Hospital, Paris, France

Outcome

Type Measure Description Time frame Safety issue
Primary Immuno-virologic criterion At Months 120 (10years), the antibody titers of neutralizers by PRNT (Plaque reduction neutralization test) and pseudotypes will be determined At Months 120 (10years)
Secondary 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. At Months 120 (10years)
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