An Open-Label, Randomized, Phase I Study in Healthy Male Adults to Evaluate the Safety of a Measles Vaccine (Dry Powder)Administered by Two Devices
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of Unsolicited Adverse Events Within 84 Days
研究概览
简要总结
This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Subjects will be followed for 180 days for safety.
详细描述
This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Solicited reactions will be assessed for first 14 days after vaccination and unsolicited adverse events will be assessed till 84 days after vaccination. Subjects will be followed for 180 days for any SAEs.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male adults of age of 18-45 years.
- •Measles immune, as determined by IgG antibody levels.
- •Healthy as supported by medical history, physical examination and laboratory evaluation on preset parameters.
- •Signed informed consent for participation in trial and for HIV screening.
排除标准
- •Medical history of immunodeficiency/suppression or subject with history of close contact with immunocompromised/ immunosuppressed person.
- •Chronic administration of immunosuppressants or other immune modifying agents
- •Acute febrile illness or suspected measles illness or acute infectious disease
- •Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, psychiatric, cardiovascular, neurological, hepatic or renal functional abnormality which in the opinion of the investigator, might interfere with the study objectives
- •History of seizure disorders
- •Major congenital defects
- •Thrombocytopenia or known bleeding disorders
- •History of a previous severe allergic reaction
- •Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen
- •Known hypersensitivity to any component of the study vaccine
研究组 & 干预措施
PMV via Puffhaler® Device
The dry powder measles vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.
干预措施: PMV via Puffhaler® device (Biological)
PMV via SoloventTM device
The dry powder measles vaccine will be administered via a SoloventTM device. A single dose of 10 mg will be used.
干预措施: PMV via SoloventTM device (Biological)
Licensed Subcutaneous Measles Vaccine
Licensed measles vaccine will be administered subcutaneously as single dose of 0.5 ml.
干预措施: Licensed Subcutaneous Measles Vaccine (Biological)
结局指标
主要结局
Incidence of Unsolicited Adverse Events Within 84 Days
时间窗: Day 84
Incidence of unsolicited adverse events for a period of 84 days in each group was assessed.
Incidence of Serious Adverse Events (SAEs) and New Onset Chronic Medical Conditions
时间窗: Day 180
Incidence of serious adverse events (SAEs) and new onset chronic medical conditions throughout the entire study period of 180 days in each group was assessed.
Incidence of Solicited Reactions
时间窗: Day 14
Incidence of solicited local and systemic reactions within 14 days of vaccine administration in each group was assessed.
次要结局
- The Proportion of Subjects in Each Group With Seropositive Anti-Measles IgG Antibodies(Day -7, Day 28 and Day 84)
- The Proportion of Subjects in Each Group With Seroprotective Plaque-reduction Neutralization Test (PRNT) Titre(Day -7, Day 28 and Day 84)
- The Proportion of Subjects in Each Group With Seroconversion for PRNT(Day 28 and Day 84)
- Geometric Mean Titre (GMT) by PRNT on Day -7, 28 and 84(Day -7, Day 28 and Day 84)
- Geometric Mean Concentration (GMC) for Anti-Measles IgG Antibodies(Day -7, Day 28 and Day 84)
- The Proportion of Subjects in Each Group With Seroconversion for Serum Anti-Measles IgG(Day 28 and Day 84)