Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization (SLVP023)
調査の概要
詳細な説明
This is an exploratory study using a strategy that has not been previously employed to investigate B-cell responses. Investigators will collect blood samples from the volunteers at a higher frequency than in the two previous flu seasons to better define the dynamic response to vaccination. The objective is to compare the Ig gene repertoire before and after vaccination by deep sequencing PBMC and proteomic analysis of antibody CDR3 regions at 10 different time points before and after immunization.
This is a Phase IV study of healthy adults who are given standard TIV off-season. There are no exclusions for gender, ethnicity or race. Following confirmation of written informed consent, baseline blood samples will be drawn from all study participants at Day -5, Day -3 and Day 0 prior to immunization, and at Days 1, 4, 7, 9, 11, 28 and 180 post-immunization. Volunteers will be vaccine-naïve for the 2010-2011 and 2011-2012 seasonal influenza vaccines. All participants will receive a single dose of the current seasonal influenza vaccine by intramuscular (IM) injection at Day 0.
研究の種類
入学 (実際)
段階
- フェーズ 4
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
説明
Inclusion Criteria:
- Otherwise healthy, 18-30 year old young adult.
- Availability for follow-up for the planned duration of the study at least 180 days after immunization.
- Acceptable medical history by medical history and vital signs.
Exclusion Criteria:
- Prior vaccination with 2010-2011 seasonal TIV or LAIV.
- Prior off-study vaccination with the current 2011-2012 seasonal TIV or LAIV
- Weight less than 110 pounds.
- Allergy to egg or egg products, or to vaccine components, including gelatin or thimerosal (thimerosal in TIV multidose vials only).
- Life-threatening reactions to previous influenza vaccinations
- Active systemic or serious concurrent illness, including febrile illness on the day of vaccination
- History of immunodeficiency (including HIV infection)
- Known or suspected impairment of immunologic function, including, but not limited to, clinically significant liver disease, diabetes mellitus treated with insulin, moderate to severe renal disease, or any other chronic disorder which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- Blood pressure >150 systolic or >95 diastolic at first study visit
- Hospitalization in the past year for congestive heart failure or emphysema.
- Chronic Hepatitis B or C.
- Recent or current use of immunosuppressive medication, including systemic glucocorticoids. Corticosteroid nasal sprays and topical steroids are permissible.
- Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors such as breast cancer or prostate cancer with recurrence in the past year, and any hematologic cancer such as leukemia).
- Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion of the investigator, might jeopardize volunteer safety or compliance with the protocol.
- History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular medical follow up or hospitalization during the preceding year.
- Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be reviewed by investigator to determine if this would affect the volunteer's safety.
- Receipt of blood or blood products within the past 6 months.
- Medical or psychiatric condition or occupational responsibilities that preclude participant compliance with the protocol
- Receipt of inactivated vaccine 14 days prior to study enrollment, planned vaccinations prior to completion of Visit 09 (Day 28 after study vaccination), or planned vaccination 14 days prior to Visit 10 (6 months after study vaccination).
- Receipt of live, attenuated vaccine 60 days prior to study enrollment, planned vaccination prior to completion of Visit 09 (Day 28 after study vaccination), or planned vaccination 14 days prior to Visit 10 (6 months after study vaccination).
- History of Guillain-Barré Syndrome
- Pregnant or lactating woman
- Use of investigational agents within 30 days prior to study enrollment or planned use during the study period.
- Donation of the equivalent of a unit of blood within 6 weeks prior to study enrollment, or during the first 5 weeks of study participation.
- A member of the study team or their family member, to include investigators, research laboratory staff, clinical research staff.
- Any condition which, in the opinion of the investigator, might interfere with volunteer safety, study objectives or the ability of the participant to understand or comply with the study protocol.
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
- 主な目的:基礎科学
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の:2011-2012 Fluzone IIV3 (IM)
Seasonal trivalent flu vaccine: NDC No 49281-011-50
|
2011-2012 Fluzone IIV3 vaccine delivered intramuscularly (IM)
|
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 |
時間枠 |
|---|---|
|
Number of Participants Who Received Influenza Vaccine
時間枠:Day 0 to 180 post-immunization
|
Day 0 to 180 post-immunization
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Number of Participants With Related Adverse Events
時間枠:Day 0 to 180 post-immunization
|
Day 0 to 180 post-immunization
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proteomic Analysis of Antibody CDR3 Regions at 10 Different Time Points Before and After Immunization.
時間枠:Day -5 to 180 post-immunization
|
Proteomic analysis: Identification, production, and characterization of Influenza A specific antibodies and their CDRH3 amino-acid sequences.
|
Day -5 to 180 post-immunization
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Lee J, Boutz DR, Chromikova V, Joyce MG, Vollmers C, Leung K, Horton AP, DeKosky BJ, Lee CH, Lavinder JJ, Murrin EM, Chrysostomou C, Hoi KH, Tsybovsky Y, Thomas PV, Druz A, Zhang B, Zhang Y, Wang L, Kong WP, Park D, Popova LI, Dekker CL, Davis MM, Carter CE, Ross TM, Ellington AD, Wilson PC, Marcotte EM, Mascola JR, Ippolito GC, Krammer F, Quake SR, Kwong PD, Georgiou G. Molecular-level analysis of the serum antibody repertoire in young adults before and after seasonal influenza vaccination. Nat Med. 2016 Dec;22(12):1456-1464. doi: 10.1038/nm.4224. Epub 2016 Nov 7.
- Horns F, Vollmers C, Dekker CL, Quake SR. Signatures of selection in the human antibody repertoire: Selective sweeps, competing subclones, and neutral drift. Proc Natl Acad Sci U S A. 2019 Jan 22;116(4):1261-1266. doi: 10.1073/pnas.1814213116. Epub 2019 Jan 8.
- de Bourcy CF, Angel CJ, Vollmers C, Dekker CL, Davis MM, Quake SR. Phylogenetic analysis of the human antibody repertoire reveals quantitative signatures of immune senescence and aging. Proc Natl Acad Sci U S A. 2017 Jan 31;114(5):1105-1110. doi: 10.1073/pnas.1617959114. Epub 2017 Jan 17.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (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 (見積もり)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SU-24167
- U19AI057229-06 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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。