HIV Infection Clinical Trial
— EP46 NOVAAOfficial title:
The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | December 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Voir Liste Des Centres | Paris |
Lead Sponsor | Collaborator |
---|---|
French National Agency for Research on AIDS and Viral Hepatitis |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immuno-virologic criterion | - At Day-7 will be determined the levels of antibodies by fluorescence. | DAY-7 | |
Primary | 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 | |
Primary | 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 | |
Primary | Immuno-virologic criterion | At Month 3 will be determined fluorescence, PRNT and ELISPOT. | Month 3 | |
Primary | Immuno-virologic criterion | At Month 12 will be determined fluorescence, PRNT and ELISPOT. | Month 12 | |
Primary | 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 | Clinical and biological tolerance | At Day -7 will be determined the levels of antibodies by fluorescence | day -7 | |
Secondary | clinical and biological tolerance | At Day 0: incidence of HIV+ event and general+local reactions of d°>2 after vaccination | day 0 | |
Secondary | clinical and biological tolerance | At Day7: incidence of HIV+ event and general+local reactions of d°>2 after vaccination | day 7 | |
Secondary | clinical and biological tolerance | At Day14:incidence of HIV+ event and general+local reactions of d°>2 after vaccination | day 14 | |
Secondary | clinical and biological tolerance | At Day 28:incidence of HIV+ event and general+local reactions of d°>2 after vaccination | day 28 | |
Secondary | clinical and biological tolerance | At Month3:incidence of HIV+ event and general+local reactions of d°>2 after vaccination | month 3 | |
Secondary | clinical and biological tolerance | At Month 12:incidence of HIV+ event and general+local reactions of d°>2 after vaccination | month 12 |
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