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NCT Number: NCT05450770

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

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

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Key information

Conditions

HIV Infections Arbovirus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Flavivirus Infections Genital Diseases Hemorrhagic Fevers, Viral Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mosquito-Borne Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Vector Borne Diseases Virus Diseases Yellow Fever

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yellow fever vaccination (STAMARIL)

Biological

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Predicting a sustained vaccine response 10 years later.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie COLIN DE VERDIERE

CONTACT

[email protected]

01.42.02.66.45

Vincent MEIFFREDY

CONTACT

[email protected]

01.45.59.52.06

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Bichat Hospital
  • Hôpital Cochin
  • Saint-Louis Hospital, Paris, France

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 11, 2022
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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