Phase II Study to Investigate the Kinetics of the Immune Response Generated by Influenza Virus Vaccine.
2012年2月13日 更新者：MedImmune LLC
A Randomized, Open-Label, Placebo-Controlled Trial to Investigate the Kinetics of the Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent,Types A & B, Live, Cold-Adapted (CAIV-T) in Healthy Adults Aged 18 to <65 Years.
The primary objective of this study was to perform a variety of assays on blood, serum, nasal wash and cell samples obtained from healthy adult subjects for the purposes of developing assays for application in the further investigation of immune responses generated by influenza virus vaccine, trivalent, types A & B, live, cold-adapted (liquid formulation CAIV-T; Wyeth, Marietta, PA).
調査の概要
詳細な説明
This was a randomized, open-label, placebo-controlled, outpatient study carried out in healthy adults 18 to < 65 years of age.
The study was designed to evaluate the kinetics of the immune responses generated by each of the study products in order to determine the best sampling time for future studies.
Subjects were randomized in a 1:1:1 ratio to receive a single dose of either CAIV-T, inactivated influenza virus vaccine (TIV), or placebo.
研究の種類
介入
入学 (実際)
31
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Connecticut
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Stamford、Connecticut、アメリカ、06905
- David M. Radin, MD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Subjects had to have been at least 18 years of age and less than 65 years of age at the time informed consent was obtained;
- Women of child-bearing potential had to use reliable methods of hormonal and/or nonhormonal contraception (which includes cervical cap, diaphragm, condoms with spermicide or IUD) during sexual intercourse throughout the entire study period; a negative urine pregnancy test (with detection limit of less than or equal to 25mIU/mL) no more than 24 hours prior to vaccine administration; and agreed to avoid pregnancy during participation in the study. A urine pregnancy test was also conducted at the completion of study participation. Females who were surgically sterile at time of enrollment were not required to undergo pregnancy testing.
- who were determined by medical history, physical examination and clinical judgement to be eligible for the study.
- who provided written informed consent after the nature of the study has been explained;
- who were available for one month duration of the trial (from enrollment to study completion);
- who could be reached by study staff for the post-vaccination contact [telephone, clinic or home visit].
Exclusion Criteria:
- who were perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
- with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids and intranasal steroids; or cytotoxic agents;
- who had an immunosuppressed or an immunocompromised individual living in the same household;
- who had a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine or placebo;
- who received any commercially-available or investigational injected influenza vaccine in the 6 months prior to enrollment, or a non-study influenza vaccine since enrollment;
- who previously received an intranasally administered influenza vaccine;
- who had any medical conditions that, in the opinion of the investigator, might interfere with interpretation of the study results;
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
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実験的：Cold-adapted influenza vaccine (CAIVT)
A single intranasal dose of 10^7 fluorescent focus units.
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Liquid CAIV-T vaccine for this study consisted of three cold-adapted, attenuated, reassortant strains representing the hemagglutinin (HA) and neuraminidase (NA) antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2) and B/Yamanashi/166/98 influenza virus strains.
The reassortant vaccine strains were grown in specific pathogen-free (SPF) eggs and the allantoic fluid, which contained virus, was harvested, concentrated and purified.
Each dose of CAIV-T used in this study was formulated to contain approximately 107 FFU of each of the 6:2 influenza reassortant vaccine strains.
他の名前：
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アクティブコンパレータ：Trivalent inactivated vaccine (TIV)
A single dose of commercially available Flushield was administered intramuscularly.
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TIV in this study consisted of Flushield™, manufactured by Wyeth Vaccines, Marietta, PA, USA.
Each 0.5 mL dose contained no less than 15 ug of the hemagglutinin antigens from each of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Yamanashi/166/98 strains, making TIV in this study antigenically matched to the influenza strains contained in CAIV-T.
他の名前：
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プラセボコンパレーター：Placebo
The 0.2 mL administered intranasally.
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Placebo in this study consisted of physiological saline.
The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
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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 |
|---|---|---|
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Kinetics of the hemagglutination inhibition antibody response to each vaccine strain
時間枠：Day 0-28
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The geometric mean titers for each strain between Day 0 and 28 were examined.
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Day 0-28
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Expression of IgA in nasal wash and saliva swab samples
時間枠：Days 0-28
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Nasal wash and saliva swab IgA antibody titers were expressed as the ratio of specific to total IgA.
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Days 0-28
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Expression of B-cells in peripheral blood
時間枠：Days 0-28
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The B-cell ELISPOT assays are designed to detect B-cells in the peripheral blood that are actively secreting influenza strain-specific IgG or IgA antibody.
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Days 0-28
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Number of CD3+ peripheral blood mononuclear cells secreting interferon gamma
時間枠：Days 0-28
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The number of CD3+ peripheral blood mononuclear cells (PBMCs), i.e., T-cells, secreting IFN-γ prior to and after vaccination following in vitro stimulation of these cells using the IFN-γ ELISPOT assay.
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Days 0-28
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Number of subjects with local reactions
時間枠：Days 0-7
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Local injection site reactions were collected from subjects in the TIV treatment group only.
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Days 0-7
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Number of subjects with systemic reactions
時間枠：Days 0-7
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Each study subject collected prompted reactogenicity events on a diary card worksheet for 7 days (study days 0 - 6) following vaccination.
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Days 0-7
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Number of subjects with adverse events
時間枠：Days 0-7
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An Adverse Event (or Adverse Experience, AE) was any untoward, undesired or unexpected clinical event in the form of signs, symptoms, disease or laboratory or physiological observations occurring (in a human being) in a temporal relationship to the use of a WLV product, regardless of causal relationship.
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Days 0-7
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Robert Walker, MD、MedImmune LLC
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2001年9月1日
一次修了 (実際)
2001年12月1日
研究の完了 (実際)
2001年12月1日
試験登録日
最初に提出
2005年9月12日
QC基準を満たした最初の提出物
2005年9月12日
最初の投稿 (見積もり)
2005年9月19日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年2月14日
QC基準を満たした最後の更新が送信されました
2012年2月13日
最終確認日
2012年2月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- D153 P004
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