VRC 900: 18 歳以上の成人における組織特異的免疫応答の評価
Background:
- The Vaccine Research Center (VRC) is dedicated to understanding immune responses associated with prevention and treatment of infectious diseases. To study these immune responses, researchers need to collect specimens and images from individuals who have recently had a vaccination or recovered from an infection. These specimens and images are used to study different diseases and immune responses, and can be used to investigate ways to prevent or treat different medical conditions.
Objectives:
- To evaluate blood and other tissue samples for immune responses to vaccines and natural infections.
Eligibility:
- Healthy volunteers at least 18 years of age who agree to donate specimens for research purposes.
Design:
- Participants will have clinical evaluations and will be asked to provide some of the following samples, depending on the research question being addressed. All procedures and sample donations are optional and voluntary:
- Blood samples through regular blood draws (for whole blood) and apheresis (to collect specific parts of the blood such as plasma or white blood cells)
- Urine, semen, saliva, or vaginal swab samples
- Tissue samples or biopsy specimens
- Undergo procedures such as bronchoscopy (lung and respiratory tract), gastrointestinal endoscopy (stomach and upper intestinal tract), or colonoscopy (lower intestinal tract) to obtain tissue samples
- Undergo imaging studies such as positron emission tomography (PET) or computed tomography (CT) scans
Duration of participation is variable depending on the research question but will usually last up to 1 year.
- Participants will be compensated for participation.
調査の概要
詳細な説明
Protocol Design:
This is a specimen and data collection protocol designed with the research purpose of understanding the immune responses to vaccines and infections in adult participants. The information gained will enhance the knowledge of immune correlates of protection and will help in laboratory work related to the development and validation of immunological assays. This protocol will allow Vaccine Research Center (VRC) investigators and collaborators to evaluate tissue level immune responses in participants who are recipients of Food and Drug Administration (FDA)-licensed vaccines, recipients of investigational vaccines, control subjects, and participants naturally infected with infectious diseases as examples of naturally acquired immunity. Immune responses will be evaluated using collection of blood, body fluids, mucosal and tissue samples to perform clinical evaluations for research rather than therapeutic goals. Imaging using ultrasonography may be employed to image tissues such as lymph nodes to guide sampling. Detailed studies of immune responses in blood, body fluids and a diversity of tissue types, including a variety of mucosal surfaces, will further the understanding of immune responses following vaccination or recovery from an infectious disease and will advance development of vaccines against existing, new, and re-emerging pathogens.
Subjects:
Up to 500 participants 18 years of age and older who agree to collection, use, and storage of specimens and images for research purposes will be enrolled. Participants must not be pregnant or breast-feeding for certain study sample collection procedures or to receive FDA-licensed live virus vaccines.
Study Plan:
Participants will receive information about study procedures and, if willing to participate, will sign the study informed consent. FDA-licensed vaccines may be administered to some study participants as part of study participation. As per NIH Clinical Center (CC) policy, where appropriate, participants will provide additional informed consent for study procedures.
Duration:
Individual participants may donate samples as often as permitted by the protocol and NIH CC guidelines. The CC guidance on the volume of blood drawn and other inpatient/outpatient procedures will be followed. The protocol will undergo continuing review by the Institutional Review Board (IRB) annually.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：OPS Team, VRC
- 電話番号：Not Listed
- メール：vrcops@nih.gov
研究場所
-
-
Maryland
-
Bethesda、Maryland、アメリカ、20892
- 募集
- National Institutes of Health Clinical Center
-
コンタクト：
- VRC Clinic
- 電話番号：301-451-8715
- メール：vaccines@nih.gov
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Participants 18 years of age or older willing to donate blood and tissue specimens and participate in imaging studies to evaluate the components of the immune system.
説明
-
INCLUSION CRITERIA:
- 18 years of age or older.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Able and willing to complete the informed consent process.
- Willing to donate specimens for storage to be used for research.
EXCLUSION CRITERIA:
- Any medical, psychiatric, occupational condition or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant s ability to give informed consent.
- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), use of anticoagulant medications for an ongoing medical condition, significant bruising or bleeding difficulties with intramuscular injections or blood draws. [Note: Participants taking anticoagulants, such as aspirin, prophylactically may be considered on a case to case basis.]
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：OTHER
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
1
Participants 18 years of age or older willing to donate blood and tissue specimens and participate in imaging studies to evaluate the components of the immune system |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To use specimens and accumulated data for enhancement of understanding the correlates of immune protection.
時間枠：Throughout the study
|
By sample collection and imaging studies |
Throughout the study
|
|
To evaluate blood, body fluid, and tissue immune responses and pathogen dynamics of naturally infected and antigen-na(SqrRoot) ve subjects
時間枠：Throughout the study
|
By sample collection and imaging studies |
Throughout the study
|
|
To evaluate innate, humoral, and cellular immune responses and pathogen dynamics in the context of vaccination in the blood, body fluids, excretions, and tissues
時間枠：Throughout the study
|
By sample collection and imaging studies |
Throughout the study
|
協力者と研究者
捜査官
- 主任研究者：Lesia K Dropulic, M.D.、National Institute of Allergy and Infectious Diseases (NIAID)
出版物と役立つリンク
一般刊行物
- Querec TD, Akondy RS, Lee EK, Cao W, Nakaya HI, Teuwen D, Pirani A, Gernert K, Deng J, Marzolf B, Kennedy K, Wu H, Bennouna S, Oluoch H, Miller J, Vencio RZ, Mulligan M, Aderem A, Ahmed R, Pulendran B. Systems biology approach predicts immunogenicity of the yellow fever vaccine in humans. Nat Immunol. 2009 Jan;10(1):116-125. doi: 10.1038/ni.1688. Epub 2008 Nov 23.
- Wrammert J, Miller J, Akondy R, Ahmed R. Human immune memory to yellow fever and smallpox vaccination. J Clin Immunol. 2009 Mar;29(2):151-7. doi: 10.1007/s10875-008-9267-3. Epub 2008 Dec 4.
- Plotkin SA. Vaccines: the fourth century. Clin Vaccine Immunol. 2009 Dec;16(12):1709-19. doi: 10.1128/CVI.00290-09. Epub 2009 Sep 30.
- Herrin DM, Coates EE, Costner PJ, Kemp TJ, Nason MC, Saharia KK, Pan Y, Sarwar UN, Holman L, Yamshchikov G, Koup RA, Pang YY, Seder RA, Schiller JT, Graham BS, Pinto LA, Ledgerwood JE. Comparison of adaptive and innate immune responses induced by licensed vaccines for Human Papillomavirus. Hum Vaccin Immunother. 2014;10(12):3446-54. doi: 10.4161/hv.34408.
研究記録日
主要日程の研究
研究開始 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。