- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02675608
Vaccine Efficacy in Diabetic and Elderly Patients
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Louisiana
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New Orleans, Louisiana, Stati Uniti, 70112
- Tulane Clinical Translational Unit
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Year 1 Inclusion Criteria:
- Group 1: Must be 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
- Group 2: Must be ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
- Group 3: Must be between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
- Group 4: Must be ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
- Group 5: Must be between 35-50 years of age, meet the criteria listed above for non-diabetic subjects in Group 1, with the exception of chronic HIV with or without hepatitis B or C infection, and have current medical history of CD4 T-cell counts 300-800.
Year 1 Exclusion Criteria:
- a history of sensitivity to any of the vaccine components or to influenza vaccine
- a history of Guillain-Barré syndrome
- a history of known or suspected impairment of immunologic function outside of criteria described in the inclusion criteria, including clinically significant liver disease, arthritis, moderate to severe renal (kidney) disease, and ongoing infections
- a history of a bleeding disorder or received anticoagulants within the last 3 weeks
- received the influenza vaccine in the past 6 months or any other vaccines within the last 3 months
- received immunosuppressive therapy within the last 6 months
- received long-term systemic corticosteroid therapy for more than 2 consecutive weeks within 3 months
- received blood or blood-derived products within the last 3 months
- a daily aspirin intake of >81mg
- a blood pressure >150/95 at screening
Year 2 Inclusion Criteria:
Group 1: They are between 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
Group 2: They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
Group 3: If they are between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
NOTE: Current diabetes is defined by patient report of physician diagnosis. Subjects with a history of diabetes which has resolved and no longer requires therapy are not considered to have current diabetes, e.g, women with a history of gestational diabetes, steroid-induced or medication-induced.
Group 4: If they are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
Year 2 Subjects will be excluded if they have any of the following:
- a history of known or suspected impairment of immunologic function, including clinically significant liver disease, arthritis, moderate to severe renal (kidney) disease, HIV, and ongoing infections
- a history of a bleeding disorder or received anticoagulants within the last 3 weeks
- a history of heart failure
- a history of receiving immunosuppressive therapy within the last 6 months
- a history of receiving long-term systemic corticosteroid therapy for more than 2 consecutive weeks within 3 months
- a history of receiving blood or blood-derived products within the last 3 months
- a daily aspirin intake of >325mg
- are pregnant
There are no inclusion/exclusion criteria based on race. Each group will have a targeted enrollment of 50% female to male ratio. Women cannot be pregnant or breastfeeding. There will be no children involved in this study.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Retrospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Year 1 Group 1
They are between 18-65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
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On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Altri nomi:
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Year 1 Group 2
They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; have no history of immunodeficiency or weakened immunologic function; do not have diabetes; and do not have chronic HIV or hepatitis B or C infection.
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On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Altri nomi:
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Year 1 Group 3
They are between 18-65 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
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On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Altri nomi:
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Year 1 Group 4
They are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
|
On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Altri nomi:
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Year 1 Group 5
They are between 35-50 years of age, meet the criteria listed above for non-diabetic subjects in Group 1, with the exception of chronic HIV with or without hepatitis B or C infection, and have current medical history of CD4 T-cell counts 300-800.
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On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
Altri nomi:
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Year 2 Group 1
They are between 18-64 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
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Year 2 Group 2
They are ≥65 years of age, are medically stable and ambulatory; have no active systemic or serious concurrent illness; do not have diabetes.
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Year 2 Group 3
If they are between 18-64 years of age, are currently diabetic, and meet the criteria listed above for not diabetic subjects in Group 1, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
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Year 2 Group 4
If they are ≥65 years of age, are currently diabetic, and meet the criteria listed above for non-diabetic subjects in Group 2, with the exception of having pre-diagnosed type-2 diabetes mellitus (e.g., a history of hemoglobin A1C or HbA1C scores of > 6.5%).
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in HAI titer from day 0 to day 30 (+/- 4 days)
Lasso di tempo: 30 days (+/- 4 days)
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Blood samples collected days 0 and 30 will be evaluated and compared for flu antibodies using the standards HAI assay with individual virus strains contained in vaccine.
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30 days (+/- 4 days)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Inflammatory Soluble Factor and Cellular Analysis
Lasso di tempo: day 0
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Inflammatory Analysis will be performed on day 0 samples.
Soluble factors in the serum will be analyzed using flow cytometry and bioplex.
This analysis will evaluate cellular proliferation, senescence, and recognized inflammatory subsets within myeloid and lymphoid cell subsets.
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day 0
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Inflammatory Soluble Factor and Cellular Analysis additional measurements
Lasso di tempo: day 30 (+/- 4 days)
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Additional Inflammatory Analysis will be performed on day 30 samples.
Soluble factors in the serum will be analyzed using flow cytometry and bioplex.
This analysis will evaluate cellular proliferation, senescence, and recognized inflammatory subsets within myeloid and lymphoid cell subsets.
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day 30 (+/- 4 days)
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Elizabeth B Norton, MPH, PhD, Tulane University School of Medicine
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 15-727936
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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