Immunity to Yellow Fever in HIV-infected Patients 10 Years After a Primary Anti-yellow Fever Vaccination

• Sponsor: ANRS, Emerging Infectious Diseases (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05450770
• Collaborator: Saint-Louis Hospital, Paris, France (Other), Bichat Hospital (Other), Hôpital Cochin (Other)
• Enrollment: 60
• Arms: 2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
HIV Infections; Yellow Fever	Biological: Yellow fever vaccination (STAMARIL)	N/A

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

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Prevention
• Official Title: The Yellow Fever Vaccine Immunity in HIV Infected Patients: Studies of Immunological Responses at 10 Years (ANRS 0146s NovaaTen)
• Anticipated Study Start Date: Jul 1, 2022
• Anticipated Primary Completion Date: Jul 1, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HIV+ GROUP 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).	Biological: Yellow fever vaccination (STAMARIL); Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects
Other: HIV- GROUP 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.	Biological: Yellow fever vaccination (STAMARIL); Yellow fever vaccination (STAMARIL) for HIV positive and negative subjects

Outcome Measures

Primary Outcome Measures

1. Immuno-virologic criterion [At Months 120 (10years)]

   At Months 120 (10years), the antibody titers of neutralizers by PRNT (Plaque reduction neutralization test) and pseudotypes will be determined

Secondary Outcome Measures

1. Predicting a sustained vaccine response 10 years later. [At Months 120 (10years)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• ANRS, Emerging Infectious Diseases
• Saint-Louis Hospital, Paris, France
• Bichat Hospital
• Hôpital Cochin

Investigators

• Study Director: Nathalie COLIN de VERDIERE, Maladies Infectieuses St Louis Paris
• Principal Investigator: Odile LAUNAY, CIC Cochin Paris
• Principal Investigator: Jade GHOSN, Hôpital Bichat Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ANRS, Emerging Infectious Diseases
• ClinicalTrials.gov Identifier: NCT05450770
• Other Study ID Numbers: ANRS 0146s NovaaTen
• First Posted: Jul 11, 2022
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Yellow Fever; Fever

Study Results

No Results Posted as of Jul 11, 2022