Overview

This trial is active, not recruiting.

Conditions hiv infection, yellow fever
Treatments yellow fever vaccination (stamaril)
Phase phase 3
Sponsor French National Agency for Research on AIDS and Viral Hepatitis
Start date July 2011
End date May 2017
Trial size 71 participants
Trial identifier NCT01426243, 2009-014921-17

Summary

Main objective :

To develop the tools for evaluation of humoral and cell-mediated immunity after Yellow Fever Vaccine (YFV) and compare virological and immune responses in HIV-positive and HIV-negative individuals who had not been given YFV before.

Secondary objectives :

- To develop and assess ELISPOT technology for yellow fever and to measure the response within 7, 14, 28, 90 and 365 days of administration of YFV in 30 HIV negative subjects and 40 HIV positive subjects (CD4 > 350/mm3 under Highly Active Antiretroviral Therapy (HAART) for at least one year, with a viral load < 50 copies/mL since at least 6 months) in terms of : (1) seroconversion by fluorescence, (2) cytotoxic response in ELISPOT, (3) neutralizing antibody levels in Plaque reduction neutralization test (PRNT:reference method) and a new pseudotype based method, (4) post-vaccination viremia and (5) diversity of viral quasi-species.

- To assess the impact of YFV on the T-lymphocyte response against HIV by ELISPOT and viral load.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
40 HIV positive adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment), > 350 CD4/mm3 (with half of them a nadir < 200 CD4/mm3) and a viral load < 50 copies/mL for at least 6 months. Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen.
yellow fever vaccination (stamaril)
Yellow fever vaccination (STAMARIL)
(Other)
Voluntary HIV negative subjects matched according to age (18-40 years and 40-55 years) and with HIV positive subjects, vaccinated at J0 and followed over one year
yellow fever vaccination (stamaril)
Yellow fever vaccination (STAMARIL)
yellow fever vaccination (stamaril)
Yellow fever vaccination (STAMARIL)

Primary Outcomes

Measure
Immuno-virologic criterion
time frame: DAY-7
Immuno-virologic criterion
time frame: Day 0
Immuno-virologic criterion
time frame: Day 28
Immuno-virologic criterion
time frame: Month 3
Immuno-virologic criterion
time frame: Month 12
Immuno-virologic criterion
time frame: Day 7

Secondary Outcomes

Measure
Clinical and biological tolerance
time frame: day -7
clinical and biological tolerance
time frame: day 0
clinical and biological tolerance
time frame: day 7
clinical and biological tolerance
time frame: day 14
clinical and biological tolerance
time frame: day 28
clinical and biological tolerance
time frame: month 3
clinical and biological tolerance
time frame: month 12

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Group 1: Voluntary HIV positive subjects Inclusion Criteria: - Adults under HAART for at least one year (and stable on treatment for at least 3 months prior to enrolment) - > 350 CD4/mm3 (with half of them a nadir < 200 CD4/mm3) and a viral load < 50 copies/mL for at least 6 months. - Patients were HCV negative or non-replicative and treated for at least 2 years with normal ALT and negative HBs antigen. Exclusion Criteria: - Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive. - Administration of immunoglobulins < 3 months or any vaccine <1 month. - Pregnancy ongoing or planned during the study. - Coinfection with HCV virus untreated. - HBs Ag positive. - Hypersensitivity reaction to eggs / chicken protein; hereditary fructose intolerance. - Immunosuppression, whether congenital, idiopathic or as a result of corticosteroids systemically (at doses ≥ 20mg/d of prednisone), or due to radiation or antineoplastic older than 6 months. - History of thymic dysfunction (including thymoma and thymectomy). - For HIV + subjects: ART Celsentri or by other anti-CCR5. Group 2: HIV negative subjects Inclusion Criteria: HIV and HCV negatives Exclusion Criteria: - Previous vaccination against yellow fever or yellow fever Fluorescence anti-IgG positive. - Administration of immunoglobulins < 3 months or any vaccine <1 month. - Other vaccinations should be deferred beyond M3. - Pregnancy ongoing or planned during the study. - Coinfection with HCV virus untreated. - HBs Ag positive. - Hypersensitivity reaction to eggs / chicken protein; hereditary fructose intolerance. - Immunosuppression, whether congenital, idiopathic or as a result of corticosteroids systemically (at doses ≥ 20mg/d of prednisone), or due to radiation or antineoplastic older than 6 months. - History of thymic dysfunction (including thymoma and thymectomy). - For HIV + subjects: ART Celsentri or by other anti-CCR5, coinfection with HCV virus untreated

Additional Information

Official title The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient
Principal investigator Nathalie COLIN de VERDIERE
Description Method : Clinical Trial Phase III, Multicentre protocol at Saint-Louis hospital, Bichat hospital and Cochin-Pasteur hospital, with CERVI, INSERM U 941 and SC10 collaboration. Trial treatment : Yellow fever vaccination (STAMARIL) Criterion : Immuno-virologic: At J-7, J7, J28, M3 and M12 will be determined the levels of antibodies by fluorescence, at J0, J7, J28, M3 and M12 titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia. Titles and Amariles kinetics of viremia, neutralizing antibodies and ELISPOT will be considered as surrogate markers of response in terms of groups. Clinical and biological tolerance: At all follows up will be measured the incidence of CDC classification events (for HIV+) and general and local reactions of degree ≥ 2 in the setting of the injection of STAMARIL®. Schedule : Date of first enrolment : third quarter 2011. Inclusion period : 18 months. For each subject, participation in this trial will be for 12 months.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).