PACTR201402000749217尚未招募未知
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
THE JENNER INSTITUTE, UNIVERSITY OF OXFORD0 个研究点目标入组 65 人开始时间: 2014年1月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Week(s) 至 16 Week(s)（—）
- 性别
- All
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: BCG, and first dose of 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 10^9/L
- •Serum Creatinine concentration greater than 60 micromol/L,
- •Serum 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
研究者
相似试验
进行中（未招募）
1 期
Investigating a vaccine against plaguePlagueInfections and InfestationsISRCTN41077863niversity of Oxford36
进行中（未招募）
1 期
A first-in-human study to assess the safety of an MVA-based vaccine for Crimean-Congo Haemorrhagic Fever (MVA-CCHF) and the vaccine's ability to generate an immune responseCrimean-Congo Haemorrhagic FeverInfections and InfestationsISRCTN14935155niversity Hospital Southampton NHS Foundation Trust18
未知
1 期
DNK-651-1JPRN-jRCT2080223171DENKA SEIKEN CO.,LTD.
进行中（未招募）
1 期
A clinical trial to assess the safety, immune response, and protection against infection of novel malaria vaccines.Plasmodium falciparum infectionEUCTR2017-001049-28-GBniversity of Oxford, CTRG18
已完成
1 期
Safety and immunogenicity of a new tuberculosis (TB) vaccine (MVA85A) in healthy volunteers in Cape TowTuberculosisISRCTN17498868niversity of Oxford (UK)36