Iron and Vaccine-preventable Viral Disease - an Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Antibody avidity Index
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 viral vaccines, 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 two intramuscular vaccines (influenza and yellow fever). Vaccine response will be measured 28 and 56 days after vaccine administration in both groups. 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
研究组 & 干预措施
Immediate iron treatment
intravenous iron carboxymaltose before vaccination
干预措施: Ferinject (Dietary Supplement)
No iron treatment
no intravenous iron carboxymaltose before vaccination
结局指标
主要结局
Antibody avidity Index
时间窗: at 63 days
percentage of antibodies that remain bound to beads
Antibody titers
时间窗: at 63 days
Seroconversion
时间窗: at 63 days
次要结局
- Proteomics(day 63)
- C-reactive protein(day 63)
- retinol binding protein(day 63)
- immune cell populations(day 63)
- Immune cell cytokine secretion(day 35)
- antiviral immunoglobulin G response(day 63)
- Hemoglobin(day 63)
- plasma zinc(day 63)
- Transcriptomics(day 63)
- Plasma Ferritin(day 63)
- Transferrin saturation(day 63)
- Transferrin receptor(day 63)
- Alpha-glycoprotein(day 56)
研究者
Nicole Stoffel
PhD
Swiss Federal Institute of Technology