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

HIV Infections Clinical Trial

Official title:

The Yellow Fever Vaccine Immunity in HIV Infected Patients: Studies of Immunological Responses at 10 Years (ANRS 0146s NovaaTen)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05450770
• Other study ID #: ANRS 0146s NovaaTen
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Fever
• HIV Infections
• Yellow Fever

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)