Back to resultsThe Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient. (EP46 NOVAA)
Primary Purpose
HIV Infection, Yellow Fever
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL)
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infection
Eligibility Criteria
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
Sites / Locations
- Voir Liste Des Centres
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Voluntary HIV positive subjects
HIV negative subjects
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Immuno-virologic criterion
- At Day-7 will be determined the levels of antibodies by fluorescence.
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
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
Immuno-virologic criterion
At Month 3 will be determined fluorescence, PRNT and ELISPOT.
Immuno-virologic criterion
At Month 12 will be determined fluorescence, PRNT and ELISPOT.
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
Secondary Outcome Measures
Clinical and biological tolerance
At Day -7 will be determined the levels of antibodies by fluorescence
clinical and biological tolerance
At Day 0: incidence of HIV+ event and general+local reactions of d°>2 after vaccination
clinical and biological tolerance
At Day7: incidence of HIV+ event and general+local reactions of d°>2 after vaccination
clinical and biological tolerance
At Day14:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
clinical and biological tolerance
At Day 28:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
clinical and biological tolerance
At Month3:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
clinical and biological tolerance
At Month 12:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Full Information
NCT ID
NCT01426243
First Posted
February 10, 2011
Last Updated
January 17, 2019
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
1. Study Identification
Unique Protocol Identification Number
NCT01426243
Brief Title
The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient.
Acronym
EP46 NOVAA
Official Title
The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Yellow Fever
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Voluntary HIV positive subjects
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HIV negative subjects
Arm Type
Other
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Yellow fever vaccination (STAMARIL)
Intervention Description
Yellow fever vaccination (STAMARIL)
Intervention Type
Biological
Intervention Name(s)
Yellow fever vaccination (STAMARIL)
Intervention Description
Yellow fever vaccination (STAMARIL)
Primary Outcome Measure Information:
Title
Immuno-virologic criterion
Description
- At Day-7 will be determined the levels of antibodies by fluorescence.
Time Frame
DAY-7
Title
Immuno-virologic criterion
Description
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
Time Frame
Day 0
Title
Immuno-virologic criterion
Description
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
Time Frame
Day 28
Title
Immuno-virologic criterion
Description
At Month 3 will be determined fluorescence, PRNT and ELISPOT.
Time Frame
Month 3
Title
Immuno-virologic criterion
Description
At Month 12 will be determined fluorescence, PRNT and ELISPOT.
Time Frame
Month 12
Title
Immuno-virologic criterion
Description
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
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Clinical and biological tolerance
Description
At Day -7 will be determined the levels of antibodies by fluorescence
Time Frame
day -7
Title
clinical and biological tolerance
Description
At Day 0: incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Time Frame
day 0
Title
clinical and biological tolerance
Description
At Day7: incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Time Frame
day 7
Title
clinical and biological tolerance
Description
At Day14:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Time Frame
day 14
Title
clinical and biological tolerance
Description
At Day 28:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Time Frame
day 28
Title
clinical and biological tolerance
Description
At Month3:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Time Frame
month 3
Title
clinical and biological tolerance
Description
At Month 12:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
Time Frame
month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie COLIN de VERDIERE
Organizational Affiliation
Maladies Infectieuses St Louis Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sophie MATHERON
Organizational Affiliation
Maladies Infectieuses et Tropicales Bichat Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Odile LAUNAY
Organizational Affiliation
CIC Cochin Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Voir Liste Des Centres
City
Paris
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
30096071
Citation
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.
Results Reference
derived
Links:
URL
http://anrs.fr
Description
Related Info
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The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient.
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