Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- JJ COVID-19 vaccine response
研究概览
简要总结
Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation.
The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination).
We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson & Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.
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
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing and able to give informed consent for participation in the trial
- •Female aged 18-49 years
- •Moderate anemia (Hb <110 g/L, but not severely anemic with Hb <80 g/L)
- •Iron deficient (ZnPP >40 mmol/mol haem)
- •Anticipated residence in the study area for the study duration
排除标准
- •Major chronic infecious disease (e.g., HIV infection);
- •Major chronic non-infecious disease (e.g., Type 2 diabetes, cancer);
- •Chronic medications;
- •Use of iron-containing mineral and vitamin supplementation 2 weeks prior to study start;
- •COVID-19 vaccine or confirmed COVID-19 infection within the past 2 years
- •MenACWY vaccine in the past
- •Typhim Vi vaccine in the past
- •Pregnant (confirmed by rapid test during screening)
- •Malaria (confirmed by rapid test) à study start will be postponed
结局指标
主要结局
JJ COVID-19 vaccine response
时间窗: Day 56
Anti-spike (S1) IgG and anti-receptor-binding domain (RBD) IgG against SARS-COV-2
MenACWY vaccine response
时间窗: Day 56
Measurement of antibody response against serogroups A, C, W, and Y.
Typhoid vaccine response
时间窗: Day 56
Measurement of antibody response against Typhoid
次要结局
- Hemoglobin(Day 56)
- Serum ferritin(Day 56)
- soluble transferrin receptor(Day 56)
- alpha- 1- glycoprotein(Day 56)
- Typhim Vi specific B-cell response(Day 56)
- Plasma iron(Day 56)
- Retinol binding protein(Day 56)
- Total iron binding capacity(Day 56)
- Transferrin saturation(Day 56)
- C- reactive protein(Day 56)
- Plasma zinc(Day 1)
- COVID-19 specific T cell response(Day 56)