Single Group Study of the Safety of and Immune Response to a Bird Flu Virus Vaccine (H5N1) in Healthy Adults
Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine Modified H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca), a Live Attenuated Virus Vaccine Candidate for Prevention of Avian Influenza H5N1 Infection in the Event of a Pandemic
調査の概要
状態
詳細な説明
According to the World Health Organization, the current pandemic risk associated with avian influenza H5N1 infection is serious, as an increasing number of humans are infected. Currently, H5N1 influenza transmission occurs in humans when they are exposed through direct contact to infected poultry or surfaces and objects contaminated by infected poultry feces. A pandemic occurs when a new influenza subtype emerges that infects humans, causes serious illness, and spreads easily among humans. The development of a safe and effective vaccine is necessary, should a pandemic occur. The purpose of this study is to evaluate the safety and immunogenicity of a live, attenuated A1 virus vaccine, H5N1 (6-2) AA ca Recombinant (A/Hong Kong/213/2003 x A/AnnArbor/6/60 ca).
This study will last approximately 16 weeks. Participation in this study includes a hospital stay in an isolation unit at the Johns Hopkins Bayview Medical Center. All participants will receive two doses of vaccine in nasal spray form, at study entry and sometime between 4 and 8 weeks after initial vaccination. Participants will be admitted to the isolation unit 2 days prior to each vaccination. A targeted physical exam will occur daily following each vaccination until discharge. Participants will not be discharged until nasal washes are negative. Vital signs measurement will be done at least twice daily for the duration of the inpatient stay. A follow-up outpatient visit will occur approximately 4 weeks following each vaccination. Blood and urine collection will occur at selected timepoints throughout the study.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Maryland
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Baltimore、Maryland、アメリカ、21205
- Center for Immunization Research (CIR), Johns Hopkins Bloomberg School of Public Health
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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:
- Good general health
- Available for the duration of the study
- Willing to use acceptable forms of contraception for the duration of the study
Exclusion Criteria:
- Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
- Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may affect study participation
- Medical, work, or family problems as a result of alcohol or illicit drug use within 12 months prior to study entry
- Previously enrolled in an H5N1 influenza vaccine trial or in any study of an avian influenza vaccine
- Seropositive to the H5N1 influenza A virus (serum hemagglutination inhibitor [HI] titer greater than 1:8)
- Illegal drug use or dependency determined by urine test
- History of severe allergic reaction
- Allergy to oseltamivir
- Asthma or reactive airways disease within 2 years prior to study entry
- History of Guillain-Barre syndrome
- HIV infected
- Hepatitis C virus infected
- Positive for hepatitis B surface antigen (HBsAg)
- Known immunodeficiency syndrome
- Use of corticosteroid or immunosuppressive drugs within 30 days prior to vaccination. Participants who have used topical corticosteroids are not excluded.
- Live vaccines within 4 weeks prior to study vaccination
- Killed vaccines within 2 weeks prior to study vaccination
- Absence of spleen
- Blood products within 6 months prior to study vaccination
- Current smoker unwilling to stop smoking for the duration of the study
- Have traveled to the Southern Hemisphere or Asia within 14 days prior to study vaccination
- Have traveled on a cruise ship within 14 days prior to study vaccination
- Work in the poultry industry
- Other investigational vaccine or drug within 30 days prior to study vaccination
- Allergy to eggs or egg products
- Purified protein derivative (PPD) positive (positive tuberculosis [TB] test)
- Have family member with immunodeficiency-related condition
- Other condition that, in the opinion of the investigator, may interfere with the study
- Pregnancy or breastfeeding
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：防止
- 割り当て：非ランダム化
- 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 |
|---|---|
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実験的：1
Two, 0.5 ml doses of vaccine in nasal spray form administered at study entry and sometime between 4 and 8 weeks after initial vaccination
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Intranasal vaccine
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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 |
時間枠 |
|---|---|
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Safety, defined as the frequency of vaccine-related reactogenicity events
時間枠：During the acute monitoring (in-patient) phase of the study
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During the acute monitoring (in-patient) phase of the study
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Immunogenicity, determined by anti-H5N1 antibody titer
時間枠：At Days 0, 7, 9, and 28 with respect to vaccination
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At Days 0, 7, 9, and 28 with respect to vaccination
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Ungchusak K, Auewarakul P, Dowell SF, Kitphati R, Auwanit W, Puthavathana P, Uiprasertkul M, Boonnak K, Pittayawonganon C, Cox NJ, Zaki SR, Thawatsupha P, Chittaganpitch M, Khontong R, Simmerman JM, Chunsutthiwat S. Probable person-to-person transmission of avian influenza A (H5N1). N Engl J Med. 2005 Jan 27;352(4):333-40. doi: 10.1056/NEJMoa044021. Epub 2005 Jan 24.
- Cinatl J Jr, Michaelis M, Doerr HW. The threat of avian influenza A (H5N1). Part IV: Development of vaccines. Med Microbiol Immunol. 2007 Dec;196(4):213-25. doi: 10.1007/s00430-007-0052-3. Epub 2007 Jun 1.
- Cox MM. Vaccines in development against avian influenza. Minerva Med. 2007 Apr;98(2):145-53.
- Peiris JS, Yu WC, Leung CW, Cheung CY, Ng WF, Nicholls JM, Ng TK, Chan KH, Lai ST, Lim WL, Yuen KY, Guan Y. Re-emergence of fatal human influenza A subtype H5N1 disease. Lancet. 2004 Feb 21;363(9409):617-9. doi: 10.1016/S0140-6736(04)15595-5.
- Rajagopal S, Treanor J. Pandemic (avian) influenza. Semin Respir Crit Care Med. 2007 Apr;28(2):159-70. doi: 10.1055/s-2007-976488.
- Karron RA, Talaat K, Luke C, Callahan K, Thumar B, Dilorenzo S, McAuliffe J, Schappell E, Suguitan A, Mills K, Chen G, Lamirande E, Coelingh K, Jin H, Murphy BR, Kemble G, Subbarao K. Evaluation of two live attenuated cold-adapted H5N1 influenza virus vaccines in healthy adults. Vaccine. 2009 Aug 6;27(36):4953-60. doi: 10.1016/j.vaccine.2009.05.099. Epub 2009 Jun 21.
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
- CIR 239
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