The Yellow Fever Vaccine Immunity in HIV Infected Patients : Development of New Assays for Virological and Immunological Monitoring in HIV Infected Patient. (EP46 NOVAA)
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| ClinicalTrials.gov Identifier: NCT01426243 |
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Recruitment Status :
Completed
First Posted : August 31, 2011
Last Update Posted : January 18, 2019
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infection Yellow Fever | Biological: Yellow fever vaccination (STAMARIL) | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 71 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| 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 Start Date : | July 2011 |
| Actual Primary Completion Date : | February 2017 |
| Actual Study Completion Date : | December 2017 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 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.
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Biological: Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL) |
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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
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Biological: Yellow fever vaccination (STAMARIL)
Yellow fever vaccination (STAMARIL) Biological: Yellow fever vaccination (STAMARIL) Yellow fever vaccination (STAMARIL) |
- Immuno-virologic criterion [ Time Frame: DAY-7 ]- At Day-7 will be determined the levels of antibodies by fluorescence.
- Immuno-virologic criterion [ Time Frame: Day 0 ]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 [ Time Frame: Day 28 ]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 [ Time Frame: Month 3 ]At Month 3 will be determined fluorescence, PRNT and ELISPOT.
- Immuno-virologic criterion [ Time Frame: Month 12 ]At Month 12 will be determined fluorescence, PRNT and ELISPOT.
- Immuno-virologic criterion [ Time Frame: Day 7 ]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
- Clinical and biological tolerance [ Time Frame: day -7 ]At Day -7 will be determined the levels of antibodies by fluorescence
- clinical and biological tolerance [ Time Frame: day 0 ]At Day 0: incidence of HIV+ event and general+local reactions of d°>2 after vaccination
- clinical and biological tolerance [ Time Frame: day 7 ]At Day7: incidence of HIV+ event and general+local reactions of d°>2 after vaccination
- clinical and biological tolerance [ Time Frame: day 14 ]At Day14:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
- clinical and biological tolerance [ Time Frame: day 28 ]At Day 28:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
- clinical and biological tolerance [ Time Frame: month 3 ]At Month3:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
- clinical and biological tolerance [ Time Frame: month 12 ]At Month 12:incidence of HIV+ event and general+local reactions of d°>2 after vaccination
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426243
| France | |
| Voir Liste Des Centres | |
| Paris, France | |
| Principal Investigator: | 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | French National Agency for Research on AIDS and Viral Hepatitis |
| ClinicalTrials.gov Identifier: | NCT01426243 |
| Other Study ID Numbers: |
2009-014921-17 |
| First Posted: | August 31, 2011 Key Record Dates |
| Last Update Posted: | January 18, 2019 |
| Last Verified: | February 2018 |
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Yellow Fever Fever Infections RNA Virus Infections Virus Diseases Body Temperature Changes |
Arbovirus Infections Vector Borne Diseases Flavivirus Infections Flaviviridae Infections Hemorrhagic Fevers, Viral |