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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 4
Contacts et emplacements
Coordonnées de l'étude
- Nom: Patrick Olson, MD
- Numéro de téléphone: 314-454-0058
- E-mail: olsonp@wustl.edu
Sauvegarde des contacts de l'étude
- Nom: Rachel Presti, MD
- Numéro de téléphone: 314-454-0058
- E-mail: prestir@wustl.edu
Lieux d'étude
-
-
Missouri
-
St Louis, Missouri, États-Unis, 63110
- Recrutement
- Washington University
-
Contact:
- Patrick Olson, MD
- Numéro de téléphone: 314-454-0058
- E-mail: olsonp@wustl.edu
-
Contact:
- Rachel Presti, MD
- Numéro de téléphone: 314-454-0058
- E-mail: prestir@wustl.edu
-
Chercheur principal:
- Patrick Olson, MD
-
Sous-enquêteur:
- Rachel Presti, MD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Vaccination
Standard, seasonal flu vaccine |
Standard, seasonal flu vaccines Rabies vaccine for pre-exposure |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Rabies-specific antibody titers at day 29 compared to pre-vaccination baseline.
Délai: From vaccination day 1 to day 29
|
From vaccination day 1 to day 29
|
Collaborateurs et enquêteurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 202607188
- U19AI181103 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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
Délai de partage IPD
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.
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
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