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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorANRS, Emerging Infectious Diseases

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Non-volunteers for the 10-year follow-up

Subject under curatorship, guardianship or safeguard of justice.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Yellow fever vaccination (STAMARIL)

    Biological/Vaccine

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: HIV+ GROUPActive comparator 1 intervention
Group B: HIV- GROUPOther 1 intervention

Trial outcomes

Primary outcomes

1

Immuno-virologic criterion

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

Time frame
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.

Time frame
At Months 120 (10years)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ANRS, Emerging Infectious Diseases

Lead sponsor

Saint-Louis Hospital, Paris, France

Collaborator

Bichat Hospital

Collaborator

Hôpital Cochin

Collaborator

This trial is not recruiting at the moment. You can still explore other options: