- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02031874
Immunogenicity of Inactivated Swine H1N1 Vaccine In HIV Infected Children - The Miami Cohort Study
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Patients will be recruited from HIV-1 outpatient clinic at the time the novel H1N1 vaccine becomes available. Demographic data will be collected after enrollment including HIV-1 viral load (VL) and CD4 count from last visit, antiretroviral therapy, gender and age. Patients will be asked to document adverse reactions observed during this study such as tenderness, pain, redness, and swelling at the injection site as well as systemic adverse reactions such as headache, malaise, and muscle aches. A subject will be withdrawn from the study if a serious adverse reaction occurs such as allergic reaction to a vaccine component or development with a progressive neurological disorder without definitive diagnosis. Statistical analysis will be performed after the viral load and CD4 counts are resulted from the day 30. The microneutralization assays and the titers will be analyzed post day 7 and 37. If the cohort does not seem to generate adequate responses, the study will be discontinued and no further samples collected.
Vaccination:
Since immunocompromised persons may have a diminished immune response to Influenza A (H1N1) 2009 Monovalent Vaccine, a higher antigen load will be used for this study as recommended by the National Center for Immunization and Respiratory Diseases and Centers for Disease Control and Prevention. All of the patients will be given a 0.5 ml intramuscular doses of A/California/7/2009 H1N1 strain inactivated vaccine in the deltoid muscle; all patients will receive a second dose after 4 weeks. Each vaccine dose will contain 15 µg each of H1N1 monovalent antigen. Patients under the age of 9 will receive the second vaccine as standard of care, while patients 9 and older will receive a second dose as part of this study.
Study Design:
This is a pilot study designed to recruit 72 patients with CD4 counts of ≥200. Patients will be enrolled on a first come first serve basis and will attempt to reach equal numbers in gender. A dose (15 µg) of the vaccine will be administered at day 0 and 30. Blood samples will be collected as in Table 1 (see Below). At each visit, the total maximum amount collected will be 17.5 ml divided in three individual samples: The first sample will be 5 ml for serum separation used in the detection of Hemagglutination inhibition (HI) titers and micro-neutralization (MN) assays. The second sample will be 10 ml processed for viral load, CD4 counts and ELISPOT functional B cell assays. The third sample will be 2.5 ml collected in a Paxgene RNA tube for future microarray testing. Based on the HI titer and MN responses obtained, the patients will be classified into three distinct subgroups: (a) high responders with ≥ 4 fold titer increases compared to baseline, (b) moderate responders with ≥ 2 and < 4 fold increases and (c) low responders with < 2 fold increases. From these subgroups, up to 25 complete patient's samples from the high and low responders will be selected for microarray studies. The microarray will compare readings from all visits. These preliminary data will serve the basis for future humoral and innate immunity gene activation.
Hemagglutination inhibition (HI) and microneutralization (MN) assays will be performed on blood samples collected as described in Table 1. Two individual samples will be collected in each visit, one will be used for serum separation used in the detection of HI titers and the second sample for viral load, CD4 counts, ELISPOT and Microarray testing. Based on the HI and MN titer responses obtained, the patients will be classified into three distinct subgroups: (a) high responders with ≥ 4 fold titer increases compared to baseline, (b) moderate responders with ≥ 2 and < 4 fold increases and (c) low responders with < 2 fold increases. From these subgroups, up to 25 complete samples from the high, moderate and low responders will be selected for viral load and microarray studies.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Florida
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Miami, Florida, Forente stater, 33136
- University of Miami
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Individuals must have a positive ELISA with confirm with a western blot after 18 months of age or a positive DNA or RNA PCR
Exclusion Criteria:
- Patients with hypersensitivity to eggs or chicken protein, neomycin, or polymyxin, or life-threatening reaction to previous influenza vaccination will be excluded. Pregnant individuals will be excluded from the study at this time. Patients with a previous episode of Guillain-Barré Syndrome (GBS) in relation to a previous influenza vaccination, will also be excluded. Allergic reactions, including anaphylactic shock
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Miami Cohort
Measured vaccine response to H1N1 in HIV perinatally infected children
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Determine immunogenecity to vaccine
Tidsramme: 1 month
|
The primary objectives of this proposal are:
|
1 month
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Measure Antibody Response
Tidsramme: 6 months
|
Secondary objectives: 4. Assess the effect of H1N1 vaccine administration on antibody response to seasonal trivalent influenza vaccine (TIV). 5. Analyze potential impact of gender in the differences in antibody production, B cell stimulation and changes in both viral load and CD4 counts. |
6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ivan A Gonzalez, MD, University of Miami
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 20090858
- 5P30AI073961 (U.S. NIH-stipend/kontrakt)
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