NCT01426243

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2011

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 18, 2019

Status Verified

February 1, 2018

Enrollment Period

5.6 years

First QC Date

February 10, 2011

Last Update Submit

January 17, 2019

Conditions

HIV InfectionYellow Fever

Outcome Measures

Primary Outcomes (6)

  • Immuno-virologic criterion

    \- At Day-7 will be determined the levels of antibodies by fluorescence.

    DAY-7

  • Immuno-virologic criterion

    At Day 0 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia

    Day 0

  • Immuno-virologic criterion

    At Day 28 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis (if it's positive at day7) and nucleotide sequences on phylogenetic strains of viremia

    Day 28

  • Immuno-virologic criterion

    At Month 3 will be determined fluorescence, PRNT and ELISPOT.

    Month 3

  • Immuno-virologic criterion

    At Month 12 will be determined fluorescence, PRNT and ELISPOT.

    Month 12

  • Immuno-virologic criterion

    At Day 7 will be determined titles and neutralization with Prnt pseudotypes, the ELISPOT response anti-yellow fever, viremia with quantitative analysis and nucleotide sequences on phylogenetic strains of viremia

    Day 7

Secondary Outcomes (7)

  • Clinical and biological tolerance

    day -7

  • clinical and biological tolerance

    day 0

  • clinical and biological tolerance

    day 7

  • clinical and biological tolerance

    day 14

  • clinical and biological tolerance

    day 28

  • +2 more secondary outcomes

Study Arms (2)

Voluntary HIV positive subjects

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.

Biological: Yellow fever vaccination (STAMARIL)

HIV negative subjects

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

Biological: Yellow fever vaccination (STAMARIL)

Interventions

Yellow fever vaccination (STAMARIL)BIOLOGICAL

Yellow fever vaccination (STAMARIL)

HIV negative subjectsVoluntary HIV positive subjects

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • HIV and HCV negatives
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Voir Liste Des Centres

Paris, France

Location

Related Publications (1)

  • Colin de Verdiere N, Durier C, Samri A, Meiffredy V, Launay O, Matheron S, Mercier-Delarue S, Even S, Aboulker JP, Molina JM, Autran B, Simon F; ANRS EP46 NOVAA Group. Immunogenicity and safety of yellow fever vaccine in HIV-1-infected patients. AIDS. 2018 Oct 23;32(16):2291-2299. doi: 10.1097/QAD.0000000000001963.

    PMID: 30096071DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsYellow Fever

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMosquito-Borne DiseasesVector Borne DiseasesArbovirus InfectionsFlavivirus InfectionsFlaviviridae InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Nathalie COLIN de VERDIERE

    Maladies Infectieuses St Louis Paris

    PRINCIPAL INVESTIGATOR

  • Sophie MATHERON

    Maladies Infectieuses et Tropicales Bichat Paris

    PRINCIPAL INVESTIGATOR

  • Odile LAUNAY

    CIC Cochin Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

August 31, 2011

Study Start

July 1, 2011

Primary Completion

February 1, 2017

Study Completion

December 1, 2017

Last Updated

January 18, 2019

Record last verified: 2018-02

Locations

FR(1)