NCT02083887已完成1 期
A Phase I Study to Assess the Safety and Immunogenicity of ChAd63 ME-TRAP - MVA ME-TRAP Heterologous Prime-boost Vaccination Co-administered With EPI Vaccines in Gambian Infants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Safety of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines
研究概览
简要总结
Two vaccines, ChAd63 ME-TRAP and MVA ME-TRAP, are being tested to see if they will form a safe and effective vaccination strategy against malaria. The vaccines have been found to be well tolerated when tested in Gambian adults, young children and infants, who are at risk of severe malaria. Both vaccines will be given to participating infants at the same time as some EPI (Expanded Program on Immunization) vaccines, and assess whether they are safe and still helpful in making the body's defense system respond.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Week 至 16 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1: 15 healthy infants aged 16 weeks at the time of enrolment with signed consent obtained from parents
- •Group 2: 15 healthy infants aged 8 weeks at the time of enrolment with signed consent obtained from parents
- •Group 3: 15 healthy infants aged 1 week at the time of enrolment with signed consent obtained from parents
- •Group 4 (control): 20 healthy infants aged 16, 8 and 1 weeks at the time of enrolment with signed consent obtained from parents
- •Groups 1 and 2: Receipt of all EPI vaccines according to schedule defined as follows: Bacillus Calmette-Guérin (BCG), and first dose of oral polio (OPV) and Hepatitis B vaccine within 2 weeks of birth; Penta, pneumococcal vaccine, OPV, rotavirus vaccine for Group 1 at 8 weeks +/- 2 weeks
排除标准
- •Birth weight less than 2.5kg
- •Significant antenatal, perinatal or early postnatal complications as judged by the PI or other delegated individual
- •Any signs of acute illness as judged by the PI or other delegated individual
- •Axillary temperature of greater than 37.5 °C
- •Clinically significant congenital abnormalities as judged by the PI or other delegated individual
- •Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, symptomatic immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.
- •Weight for age z-scores below 2 standard deviations of normal for age
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, e.g. egg products, Kathon, neomycin, betapropiolactone.
- •History of splenectomy
- •Haemoglobin less than 10 g/dL at > 4 weeks of age or less than 13.0 g/dl at < 4 weeks of age.
- •White cell count <5.0 x 109/L
- •Serum Creatinine concentration greater than 60 micromol/L,
- •Serum alanine aminotransferase (ALT) concentration greater than 45 U/L,
- •Clinically significant jaundice
- •Any other clinically significant laboratory abnormality as judged by the PI or other delegated individual
- •Blood transfusion within one month of enrolment.
- •History of vaccination with previous experimental malaria vaccines.
- •Administration of any immunoglobulin less than two weeks before vaccination with the IMPs
- •Current participation in another clinical trial, or within 12 weeks of this study.
- •Any other finding which in the opinion of the PI or other delegated individual would increase the risk of an adverse outcome from participation in the trial.
- •Likelihood of travel away from the study area
- •Maternal HIV infection (a negative maternal HIV test will be required prior to study enrolment)
- •Positive malaria antigen test at screening
结局指标
主要结局
Safety of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines
时间窗: Participants will be followed for the duration of the study, an expected average of 36 weeks
Recording of all solicited and unsolicited local and systemic adverse events (including laboratory abnormalities considered adverse events) and the assessment of their causal relationships to the investigative medicinal products (IMPs).
次要结局
- Immunogenicity of ChAd63 ME-TRAP / MVA ME-TRAP prime boost immunisation co-administered with EPI vaccines.(Participants will be followed for the duration of the study, an expected average of 36 weeks)
研究者
研究点 (2)
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