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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 4단계
연락처 및 위치
연구 연락처
- 이름: Patrick Olson, MD
- 전화번호: 314-454-0058
- 이메일: olsonp@wustl.edu
연구 연락처 백업
- 이름: Rachel Presti, MD
- 전화번호: 314-454-0058
- 이메일: prestir@wustl.edu
연구 장소
-
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Missouri
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St Louis, Missouri, 미국, 63110
- 모병
- Washington University
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연락하다:
- Patrick Olson, MD
- 전화번호: 314-454-0058
- 이메일: olsonp@wustl.edu
-
연락하다:
- Rachel Presti, MD
- 전화번호: 314-454-0058
- 이메일: prestir@wustl.edu
-
수석 연구원:
- Patrick Olson, MD
-
부수사관:
- Rachel Presti, MD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Vaccination
Standard, seasonal flu vaccine |
Standard, seasonal flu vaccines Rabies vaccine for pre-exposure |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Rabies-specific antibody titers at day 29 compared to pre-vaccination baseline.
기간: From vaccination day 1 to day 29
|
From vaccination day 1 to day 29
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 202607188
- U19AI181103 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
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.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .