Iron and Vaccine-preventable Viral Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Seroconversion
研究概览
简要总结
Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to the COVID-19 vaccine, and whether iron treatment improves their response.
详细描述
Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in both groups will receive the 1st dose of the COVID-19 vaccine. Vaccine response will be measured 28 and 56 days after the first vaccine administration in both groups. At 28 days, participants will receive the 2nd dose of the COVID-19 vaccine. Group 2 (delayed iron treatment) will receive iron treatment at study end.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-55 years old Zinc protoporphyrin > or equal 40 mmol/mol heme hemoglobin < or equal 109 g/L no malaria no known HIV infection no medical condition that precludes study involvement no iron supplementation 1 week prior to study start no recent tuberculosis infection no vaccination of yellow fever or influenza prior to enrolment not pregnant
排除标准
- 未提供
结局指标
主要结局
Seroconversion
时间窗: day 63
Antibody avidity index
时间窗: day 63
percentage of antibodies that remain bound to beads
Antibody titers
时间窗: day 63
次要结局
- Transcriptomics(day 63)
- Immune cell cytokine secretion(day 35)
- Transferrin saturation(day 63)
- immune cell populations(day63)
- Proteomics(day 63)
- Hemoglobin(day 63)
- Transferrin receptor(day 63)
- retinol binding protein(day 63)
- plasma zinc(day 35)
- Plasma ferritin(day 63)
- C-reactive protein(day 63)
- Alpha-glycoprotein(day 63)
- antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response(day 63)
研究者
Prof Simon Karanja
PhD
Jomo Kenyatta University of Agriculture and Technology