Safety and Immune Response to Recombinant Live-Attenuated Influenza H2N2 Virus Vaccine
Phase I Inpatient Study of the Safety and Immunogenicity of Live Influenza A Vaccine H2N2 (A/Ann Arbor/6/60 ca Recombinant), a Live Attenuated Virus Vaccine Candidate for Prevention of Influenza H2N2 Infection in the Event of a Pandemic
調査の概要
詳細な説明
H2N2 influenza viruses emerged in the 1950s replacing the then circulating H1N1 human influenza virus. The first cases occurred in China in 1956, and disease became widespread in 1956-1957, resulting in the "Asian Influenza" pandemic that was responsible for between 1 and 4 million deaths worldwide. H2N2 viruses have not circulated since 1968, when they were replaced by H3N2 influenza viruses and the resurgence of H1N1 viruses. For this reason, a large proportion of the population is now susceptible to infection with H2N2 influenza. If this subtype re-emerges, it could potentially cause the next pandemic. This vaccine, therefore, is an important priority in the development of vaccines against potential pandemic influenza strains.
This vaccine trial will be conducted in the Center for Immunization Research isolation unit in the Mason F. Lord Building at the Johns Hopkins Bayview Medical Center (Baltimore, MD). The study will be initiated between April 1st and December 20th, 2008, when wild-type influenza is unlikely to be circulating in the Baltimore area.
An individual's participation in the study will last approximately 90 days. All participants will receive two vaccinations approximately 4 - 8 weeks apart. After each vaccination, participants will remain in isolation at the study site for at least nine days or until rRT-PCR assays for influenza are negative for 2 consecutive days. A physical examination and nasal wash will occur each day during the isolation period. Blood collection will occur in isolation beginning on Day 7 until release. Follow-up outpatient visits are scheduled on Days 28 and 56 after the first vaccination and on Day 28 after the second vaccination. Follow-up visits will include serum collection, nasal wash, and interim medical history.
研究の種類
入学 (予想される)
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
- Johns Hopkins Bayview Medical Center, CIR Unit at the Mason F Lord Building
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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:
- General good health
- Available for the duration of the trial
- If female, agree to use effective birth control methods for the duration of the study. More information on this criterion can be found in the protocol.
Exclusion Criteria:
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease. More information on this criterion can be found in the protocol.
- Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, intereferes with the study
- Previous receipt of FluMist or any intranasal live attenuated influenza vaccine
- Previous enrollment in an H2N2 influenza vaccine trial or in any study of an avian influenza vaccine
- Seropositive to the H2N2 influenza A virus (serum HAI titer >1:8)
- Positive urine drug toxicology test indicating narcotic use and/or dependency as defined by the Drug Enforcement Agency
- Medical, occupational, or family problems as a result of alcohol or illicit drug use within the 12 months prior to study entry
- Any condition that, in the opinion of the investigator, would interfere with the study
- History of anaphylaxis
- Allergy to oseltamivir as determined by subject report
- Current diagnosis of asthma or reactive airway disease within 2 years prior to study entry
- History of Guillain-Barre Syndrome
- HIV-1-infected
- Hepatitis C-infected
- Positive hepatitis B virus surface antigen
- Known immunodeficiency syndrome
- Use of corticosteroids (excluding topical preparations) or immunosuppressive drugs within 30 days prior to study entry
- Receipt of a live vaccine within 4 weeks or a killed vaccine within 2 weeks prior to study entry
- History of a surgical splenectomy
- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months prior to study entry
- Current smoker unwilling to stop smoking for the duration of the study. More information on this criterion can be found in the protocol.
- Travel to the Southern Hemisphere within 14 days prior to study entry
- Travel on a cruise ship within 14 days prior to study entry
- Direct contact with live poultry within the 14 days prior to the study or after study completion.
- Receipt of another investigational vaccine or drug within 30 days prior to study entry
- Allergy to eggs or egg products
- Pregnant 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
参加者は、4〜8週間（28〜62日）間隔で2回のワクチン接種を受けます
|
Approximately 0.2 ml of 10^7 TCID50 doses of vaccine administered intranasally
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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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各参加者が流すワクチンウイルスの量
時間枠：研究を通して
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研究を通して
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ワクチン関連の反応原性事象およびその他の有害事象の頻度
時間枠：研究を通して
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研究を通して
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ワクチンによって誘導される血清および鼻洗浄抗体の量
時間枠：研究を通して
|
研究を通して
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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ワクチンウイルス小屋の表現型の安定性
時間枠：研究を通して
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研究を通して
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免疫原性がワクチンの 2 回目の投与によって強化されるかどうか、およびワクチンの 1 回目の投与が 2 回目の投与の複製を制限するかどうかを決定します。
時間枠：研究を通して
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研究を通して
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Number of participants infected with the H2N2 1960 AA ca recombinant vaccine
時間枠：Throughout study
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Throughout study
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T-cell mediated and innate immune responses against the H2N2 1960 AA ca recombinant vaccine
時間枠：Throughout study
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Throughout study
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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
- Eichelberger M, Golding H, Hess M, Weir J, Subbarao K, Luke CJ, Friede M, Wood D. FDA/NIH/WHO public workshop on immune correlates of protection against influenza A viruses in support of pandemic vaccine development, Bethesda, Maryland, US, December 10-11, 2007. Vaccine. 2008 Aug 12;26(34):4299-303. doi: 10.1016/j.vaccine.2008.06.012. Epub 2008 Jun 26.
- Hampson AW. Vaccines for pandemic influenza. The history of our current vaccines, their limitations and the requirements to deal with a pandemic threat. Ann Acad Med Singap. 2008 Jun;37(6):510-7.
- Wright PF. Vaccine preparedness--are we ready for the next influenza pandemic? N Engl J Med. 2008 Jun 12;358(24):2540-3. doi: 10.1056/NEJMp0803650. No abstract available.
研究記録日
主要日程の研究
一次修了 (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
追加の関連 MeSH 用語
その他の研究ID番号
- CIR 247
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