临床试验/NCT00981695

NCT00981695Unknown1 期

An Open Randomized Phase I/II Study Evaluating Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVA, Administered to Healthy Infants Born to HIV-1-infected Mothers

Medical Research Council1 个研究点分布在 1 个国家目标入组 72 人开始时间: 2009年11月最近更新: 2011年6月16日

适应症

试验速览

阶段: 1 期
发起方: Medical Research Council
入组人数: 72
试验地点: 1
主要终点: For safety and reactogenicity: Actively and passively collected data on adverse events.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Objectives:

Primary: Safety and immunogenicity of MVA.HIVA vaccine in 20-week-old healthy Kenyan infants born to HIV-1-infected mothers.

Secondary:

HIV-1 immunogenicity comparison between MVA.HIVA and age-matched unvaccinated control arms in each cohort (breastfeeding or formula feeding)
HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants receiving MVA.HIVA
HIV-1 immunogenicity comparison between breastfeeding and formula feeding infants in the age-matched unvaccinated control group
Comparison of responses to certain Kenyan Extended Programme on Immunization (KEPI) vaccines (OPV, DTP, HBV, and HiB) between MVA.HIVA versus age-matched unvaccinated controls in each cohort, between breast versus formula feeding infants in the age-matched unvaccinated control group, and between breast versus formula infants receiving MVA.HIVA
Comparison of immune activation and phenotypic profile of lymphocytes between breast and formula feeding infants in each cohort (MVA.HIVA and age-matched unvaccinated control)
Build capacity for Infant HIV-1 Vaccine Clinical Trials Centre in Nairobi, Kenya.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: — 至 3 Days（Child）
性别: All
接受健康志愿者: 否

入选标准

未提供

排除标准

未提供

结局指标

主要结局

For safety and reactogenicity: Actively and passively collected data on adverse events.

时间窗: Up to 28 weeks after vaccination

次要结局

For immunogenicity to KEPI vaccines: Antibody levels to specific vaccines as measured by ELISA.(1 week before and 1 week after vaccination)
For immunogenicity to MVA.HIVA: Frequency of IFN-γ-producing cells determined in an ELISPOT assay after overnight stimulation with a pool of HIVA-derived peptides.(Up to 24 weeks after vaccination)

研究者

发起方

Medical Research Council

申办方类型

Other Gov

研究点 (1)

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