Study to Determine if Intranasal Proteosome-Adjuvanted Trivalent Influenza Vaccine is Safe, Immunogenic and Efficacious in the Influenza Human Viral Challenge Model
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Hvivo
- 入组人数
- 174
- 主要终点
- Reduction in Influenza Like Illness in those with laboratory confirmed influenza
研究概览
简要总结
A study to compare multiple dosage regimes of a protesomal intranasal vaccine.
详细描述
A Proteosome-adjuvanted trivalent inactivated influenza vaccine (P-TIV) administered intra-nasally was shown to be effective, safe, well tolerated, immunogenic - in both systemic and mucosal compartments - and effective at preventing influenza illness.
In two separate studies using the Human Viral Challenge Model, subjects were selected for susceptibility to A/Panama/2007/1999 (H3N2) virus and then dosed with one of three regimens: (A/New Caledonia/20/1999 (H1N1), A/Panama/2007/1999 (H3N2), B/Victoria/504/2000 or B/Shangdong/7/1997) or placebo via a nasal spray. One or two doses were given, 14 days apart, before subjects were challenged with ~8.5 x 105 EID¬50 of A/Panama/2007/1999 (H3N2) virus. Immune responses to the vaccine antigens were measured, namely serum IgG (via the aemagglutination inhibition assay (HAI)) and nasal wash secretory IgA (sIgA) antibodies (via ELISA). Viral titres in nasal washes and symptoms of influenza illness were assessed after viral challenge and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Young healthy adults as determined by medical history, physical examination, serology (HIV and Hepatitis B and C) and clinical laboratory tests.
- •Female subjects were required to provide of a history of reliable contraceptive practice.
- •Susceptibility to A/Panama/2007/1999 (H3N2) (a serum reciprocal HAI titre ≤10) was confirmed at screening. -
排除标准
- •hypersensitivity to mercurials or chicken eggs,
- •anatomic or neurologic abnormality impairing the gag reflex or contributing to aspiration, * chronic nasopharyngeal complaints,
- •abnormal electrocardiogram (ECG),
- •febrile illness or significant symptoms of upper respiratory infection on the day of vaccination or between admission to quarantine and administration of the challenge inoculum.
- •Subjects using medication or other products for rhinitis or nasal congestion,
- •Subject who had received systemic glucocorticoids within 1 month, or cytotoxic or immunosuppressive drugs within 6 months of the study start.
- •Subjects agreed not to smoke during the quarantine phase.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo Protesomal Vaccine (Biological)
Protesomal Vaccine 1 x 30 µg
Protesomal Vaccine 1 x 30 µg
干预措施: Experimental: Protesomal Vaccine 1 x 30 µg (Biological)
Protesomal Vaccine 2 x 30 µg
Protesomal Vaccine 2 x 30 µg
干预措施: Experimental: Protesomal Vaccine 2 x 30 µg (Biological)
Protesomal Vaccine 2 x 15 µg
Protesomal Vaccine 2 x 15 µg
干预措施: Experimental: Protesomal Vaccine 2 x 15 µg (Biological)
结局指标
主要结局
Reduction in Influenza Like Illness in those with laboratory confirmed influenza
时间窗: Within the duration of infection, approx 10 days
次要结局
未报告次要终点