Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
7. april 2018 oppdatert av: Brad Rosenberg, Rockefeller University
Effects of Persistent Innate Immune Activation on Vaccine Efficacy Pilot Study: Gene Expression Profiling of Immune Response to HBV Vaccination in Healthy Volunteers
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan.
Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity.This study aims to define cellular functions and genes important for the hepatitis B (HBV) vaccine immune response in healthy individuals.
The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Vaccines have been responsible for preventing millions of deaths and extending the average human lifespan.
Effective vaccines stimulate the cells of the immune system to activate genes and associated functions that bring about protective immunity.
Knowledge of those genes and cellular functions activated by effective vaccination can improve our understanding of how the immune system works and define the features necessary for a successful vaccine response.
This study aims to define cellular functions important for the hepatitis B (HBV) vaccine immune response in healthy individuals.
The investigators will identify those genes that are activated or suppressed in immune cells at various times after each dose of the HBV vaccine.
The investigators will explore these vaccine-induced "gene signatures" to characterize the cellular functions associated with an effective immune response to HBV vaccination.
The investigators hypothesize that many genes associated with innate and adaptive immune functions are important for an effective HBV vaccine response.
Studietype
Intervensjonell
Registrering (Faktiske)
10
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New York
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New York, New York, Forente stater, 10065
- The Rockefeller University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 60 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Healthy volunteer without significant medical problems
- Willing to receive three doses of an FDA-approved Hepatitis B vaccine
Exclusion Criteria:
- Male or female < 18 and > 60 years of age
- Received any vaccine within a month prior to study vaccine
- History of Hepatitis B infection
- History of previous Hepatitis B vaccination(s)
- History of Hepatitis C virus (HCV) infection or positive HCV antibody test
- Participation in another clinical study of an investigational product currently or within the past 90 days, or expected participation during this study
- Positive serum antibody against Hep B surface antigen and/or core Hep B core antigen
- human immunodeficiency virus (HIV) positive
- In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol
- Any clinically significant abnormality or medical history or physical examination including history of immunodeficiency or autoimmune disease
- Is pregnant or lactating
- Currently taking systemic steroids or other immunomodulatory medications including anticancer medications and antiviral medications
- Any clinically significant acute or chronic medical condition requiring care by a primary care provider (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy, substance abuse) that, in the opinion of the investigator, would preclude participation
- Unable to continue participation for 30 weeks
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Hepatitis B vaccination
All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
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All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Differentially Expressed Genes at p < 0.05 (Without Multiple Testing Correction).
Tidsramme: Day 1, Day 3, Week 1, and Week 2
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Number of differentially expressed genes at time point versus prevaccination baseline (p<0.05).
Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses.
Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
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Day 1, Day 3, Week 1, and Week 2
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Number of Significantly Differentially Expressed Genes at False Discovery Rate (FDR)< 0.05 (Upon Correction for Multiple Testing).
Tidsramme: Day 1, Day 3, Week 1, and Week 2
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Number of significantly differentially expressed genes at time point versus prevaccination baseline (FDR<0.05).
Following Principal Components Analysis, data from one participant series was identified as a technical outlier and excluded from downstream analyses.
Differential gene expression analysis was conducted with the voom/limma tools in the R statistical framework.
|
Day 1, Day 3, Week 1, and Week 2
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Brad Rosenberg, MD, PhD, The Rockefeller University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. februar 2014
Primær fullføring (Faktiske)
6. januar 2015
Studiet fullført (Faktiske)
6. januar 2015
Datoer for studieregistrering
Først innsendt
3. februar 2014
Først innsendt som oppfylte QC-kriteriene
4. februar 2014
Først lagt ut (Anslag)
5. februar 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. mai 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. april 2018
Sist bekreftet
1. april 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- BRO-0828
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .