The Effects of Iron Treatment on Malaria and Measles Vaccine Response in Kenyan Infants With Iron Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 324
- 主要终点
- anti- C-terminal CSP IgG
研究概览
简要总结
Malaria and iron deficiency cause a significant burden of disease in Africa. Iron deficiency (ID) might affect immune responses to vaccination.
In this double-blind randomized controlled trial, we aim to assess: (1) whether ID impairs R21/Matrix-M and measles (MR) vaccine response, (2) whether iron treatment at time of vaccination improves vaccine response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's caregiver is willing and able to give informed consent
- •Male or Female, 6 months (+/- 2 weeks) of age
- •Mother at least ≥15 years of age
- •Iron deficient (erythrocyte zinc protoporphyrin (ZnPP) >61 μmol/mol heme)
- •With or without anemia (anemia defined by Hb <110 g/L)
排除标准
- •Severely anemic (Hb <70 g/L)
- •Malaria vaccination prior to enrollment
- •Medical condition that precludes study involvement
- •Iron supplementation 2 weeks before enrollment
- •Acute or chronic infection (e.g. HIV)
- •Wasted (length for height z score of ≥-2) or underweight (weight for age z score ≥-2).
研究组 & 干预措施
Iron treatment group
daily multivitamin + daily iron syrup from age 6 to 10 months
干预措施: Iron syrup (Dietary Supplement)
Iron treatment group
daily multivitamin + daily iron syrup from age 6 to 10 months
干预措施: Multivitamin syrup (Dietary Supplement)
Iron treatment group
daily multivitamin + daily iron syrup from age 6 to 10 months
干预措施: R21-Matrix/M Vaccine (malaria vaccine) (Biological)
Iron treatment group
daily multivitamin + daily iron syrup from age 6 to 10 months
干预措施: Measles-Rubella vaccine (Biological)
Control group
daily multivitamin syrup from age 6 to 10 months
干预措施: Multivitamin syrup (Dietary Supplement)
Control group
daily multivitamin syrup from age 6 to 10 months
干预措施: R21-Matrix/M Vaccine (malaria vaccine) (Biological)
Control group
daily multivitamin syrup from age 6 to 10 months
干预措施: Measles-Rubella vaccine (Biological)
结局指标
主要结局
anti- C-terminal CSP IgG
时间窗: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
anti- full lenghts circumsporozoite protein IgG
NANP-specific IgG
时间窗: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
NANP-specific IgG
anti- full lengths CSP IgG
时间窗: At 10 months of age (1 month after the 3rd R21/Matrix-M dose)
anti- full lenghts circumsporozoite protein IgG
anti-measles IgG
时间窗: At 10 months of age (1 month after the first MR dose)
anti-measles IgG titre
次要结局
- C-reactive protein(10 months of age)
- Retinol-binding protein(10 months of age)
- anti- C-terminal CSP IgG(At 9 months age (1 month after the second R21/Matrix-M dose))
- anti-measles IgG avidity(At 10 months age (1 month after the first MR dose))
- NANP-specific IgG(At 9 months age (1 month after the second R21/Matrix-M dose))
- anti- full lengths CSP IgG(At 9 months age (1 month after the second R21/Matrix-M dose))
- anti-CSP IgA(At 10 months age (1 month after the 3rd R21/Matrix-M dose))
- Soluble transferrin receptor(10 months of age)
- anti-CSP IgM(At 10 months age (1 month after the 3rd R21/Matrix-M dose))
- Plasma Ferritin(10 months of age)
- Haemoglobin(10 months of age)
- Total iron binding capacity(10 months of age)
- Plasma iron(10 months of age)
- Transferrin saturation(10 months of age)
- Alpha-glycoprotein(10 months of age)