Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
This study is being done to better understand how the immune system responds to vaccination against influenza and rabies. Researchers want to study how immune responses develop and change over time in the blood and in the lymph nodes that drain the vaccination site, following vaccination with two vaccines licensed by the U.S. Food and Drug Administration (FDA): the seasonal trivalent influenza vaccine (TIV) and the rabies vaccine (RabAvert). By studying these samples, researchers hope to learn how the body produces high-quality, long-lasting antibody and memory immune responses after vaccination. The study will also compare immune responses in younger adults to immune responses in older adults, because prior research suggests that the immune system's ability to respond to vaccination weakens with age.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Patrick Olson, MD
- Telefonnummer: 314-454-0058
- E-post: olsonp@wustl.edu
Studer Kontakt Backup
- Navn: Rachel Presti, MD
- Telefonnummer: 314-454-0058
- E-post: prestir@wustl.edu
Studiesteder
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63110
- Rekruttering
- Washington University
-
Ta kontakt med:
- Patrick Olson, MD
- Telefonnummer: 314-454-0058
- E-post: olsonp@wustl.edu
-
Ta kontakt med:
- Rachel Presti, MD
- Telefonnummer: 314-454-0058
- E-post: prestir@wustl.edu
-
Hovedetterforsker:
- Patrick Olson, MD
-
Underetterforsker:
- Rachel Presti, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Healthy participants 18 to 40 years of age or ≥65 years of age.
- Able to understand and give informed consent.
- Willing to receive RabAvert vaccine.
- Willing to receive TIV (trivalent influenza vaccine).
- In stable health, as determined by medical history and targeted physical exam related to this history.
- Willing to give blood and optional lymph node FNA (fine needle aspiration) samples.
Exclusion Criteria:
- Has a history of severe local or systemic reactions to any vaccination.
- Has a history of severe allergic reaction to any component of the rabies or influenza vaccines.
- Has a history of prior rabies vaccination, receipt of rabies post-exposure prophylaxis or rabies immunoglobulin, or known or suspected prior exposure to rabies virus.
- Has received any influenza vaccines ≤ 180 days prior to the day of injection (Day 1).
- Has a current or previous diagnosis of immunocompromising condition to include human immunodeficiency virus, immune-mediated disease requiring immunosuppressive treatment, or other immunosuppressive condition.
- Has received systemic immunosuppressants or immune-modifying drugs for > 14 days in total within 6 months prior to Screening (for corticosteroids ≥ 10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- Is acutely ill or febrile (temperature >38.0 C [100.4F] less than 72 hours prior to or at the Day 1 visit. Participants who meet this criterion may be rescheduled.
- Currently has symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator.
- History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
- Has received any vaccine ≤ 28 days prior to the injection (Day 1) or plans to receive a vaccine within 28 days before or after the study injection. These participants may be rescheduled.
- Pregnant women and nursing mothers or women who are planning to become pregnant for the study duration.
- Have donated blood, blood products or bone marrow within 30 days before study vaccination, plan to donate blood at any time during the duration of participant study participation, or plan to donate blood within 30 days after the last blood draw.
- Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
- Unwilling to use an effective method of contraception if you are of childbearing potential.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Vaccination
Standard, seasonal flu vaccine |
Standard, seasonal flu vaccines Rabies vaccine for pre-exposure |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Rabies-specific antibody titers at day 29 compared to pre-vaccination baseline.
Tidsramme: From vaccination day 1 to day 29
|
From vaccination day 1 to day 29
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 202607188
- U19AI181103 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
The data to be generated and shared from this proposal will include clinical data with low-risk for identification, clinical from patients from human cohorts (described in more detail in the proposal) and a wealth of immunological data generated from assays performed on the clinical specimens derived from these subjects. The types of data to be uploaded include mainly .xls(x) or fasta files but also potentially .pdf, .doc(x), and .txt files
IPD-delingstidsramme
Data will be deposited in the ImmPort shared data base, National Center for Biotechnology Information (NCBI), (GenBank, SRA, and dbGaP), MassIVE, PDB or EMDB data repositories. Each study deposited in ImmPort, PDB, and EMBD will be assigned a permanent digital object identifier (DOI) that will be cited in each publication. Each study or sequence(s) deposited in GenBank, SRA, or dbGaP will be assigned a permanent accession number that also will be cited in each publication. These persistent unique identifiers are searchable on Google and/or Pubmed. Each proteomic study deposited in MassIVE will be assigned a permanent ProteomeXchange accession that will be cited in each publication and is searchable on the MassIVE website. All of the data repositories to be used require rich metadata to be submitted along with each dataset to ensure that data is easy to find, access, and identify.
Tilgangskriterier for IPD-deling
Data deposited on GenBank, SRA, MassIVE, PDB or EMDB will not be controlled and will be accessible for free download by the wider community. For data in ImmPort, users will need to register and agree to a Data Use Agreement prior to free download. Summaries of studies and the contents of measured variables deposited on dbGaP will be made public, while access to individual-level data will require authorization.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
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