Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 266
- 试验地点
- 2
- 主要终点
- the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
研究概览
简要总结
This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.
详细描述
The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Health adults of both genders
- •Age ≥ 18 ≤ 50 years
- •Able to understand every required study procedure
- •Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
- •Normal values for pre-stablished laboratory assays
- •Accpetance to participate and sign the consent form
排除标准
- •Any chronic condition
- •Be on immunossupressive or stimulant therapy
- •Have egg alergy
- •Have past history of alergy to sazonal influenza vaccine
- •Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
- •Acute infectious disease during seven days prior vaccination
- •Female on breasthfeeding
- •Confirmed prior infection by pandemic influenza A
- •Participation in another clinical trial in the last 6 months
- •Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer
研究组 & 干预措施
pandemic vaccine 11
7,5µg of A/H1N1 with Al(OH)3
干预措施: pandmeic vaccine 11 (Biological)
pandemic vaccine 12
3,75µg of A/H1N1 with Al(OH)3
干预措施: pandmeic vaccine 12 (Biological)
placebo group 14
placebo
干预措施: placebo group 14 (Biological)
pandemic vaccine 1
7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
干预措施: pandemic vaccine 1 (Biological)
pandemic vaccine 2
3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
干预措施: pandemic vaccine 2 (Biological)
pandemic vaccine 13
15µg of A/H1N1 with no adjuvant
干预措施: pandmic vaccine 13 (Biological)
pandemic vaccine 5
7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
干预措施: pandemic vaccine 5 (Biological)
pandemic vaccine 6
3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
干预措施: pandemic vaccine 6 (Biological)
pandemic vaccine 9
7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
干预措施: pandemic vaccine 9 (Biological)
pandemic vaccine 10
3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
干预措施: pandemic vaccine 10 (Biological)
结局指标
主要结局
the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
时间窗: 21 days after each vaccination
Volunteers will receive two doses of vaccine,21 days apart.
次要结局
- Safety and tolerability(30 minutes and 72 hours after vaccination)