The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05450770

HIV Infections Yellow Fever

NOT_YET_RECRUITING NA

Immunogenicity and Safety of the Yellow Fever Vaccine in HIV Infected Individuals

NCT03132311

HIV Infections

RECRUITING PHASE4

"Persistence of Neutralizing Antibodies Against Yellow Fever (YF) in HIV-infected Patients"

NCT03591003

HIV Infections Yellow Fever Vaccine

COMPLETED

Clinical Trial to Evaluate the Immunogenicity and Safety of an Adjuvanted A(H1N1)v Influenza Vaccine and a Non-adjuvanted A(H1N1)v Influenza Vaccine in HIV-infected Patients (ANRS 151 Hifluvac)

NCT01008813

HIV Infections

COMPLETED PHASE2

A Phase I Multicenter Study of the Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine Given Either Alone or in Combination With IIIB rgp120/HIV-1 Vaccine in Healthy Adult Subjects (NOTE: Original Study Extended ONLY for Patients Previously Enrolled on VEU 009)

NCT00001021

HIV Infections

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection Yellow Fever

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Voluntary HIV positive subjects

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.

Group Type ACTIVE_COMPARATOR

Yellow fever vaccination (STAMARIL)

Intervention Type BIOLOGICAL

Yellow fever vaccination (STAMARIL)

HIV negative subjects

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

Group Type OTHER

Yellow fever vaccination (STAMARIL)

Intervention Type BIOLOGICAL

Yellow fever vaccination (STAMARIL)

Intervention Type BIOLOGICAL

Yellow fever vaccination (STAMARIL)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Yellow fever vaccination (STAMARIL)

Intervention Type BIOLOGICAL

Yellow fever vaccination (STAMARIL)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes