Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women

Launched by SWISS FEDERAL INSTITUTE OF TECHNOLOGY · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how oral iron supplements can affect the immune response to vaccines in women in Kenya who have iron deficiency anemia (IDA). Iron deficiency is common in many parts of Africa and can make vaccines less effective. Researchers want to find out if taking iron before getting vaccinated helps improve the body's response to vaccines, compared to taking iron at the same time as vaccination. The trial will involve women aged 18 to 49 who are moderately anemic and iron deficient, and they will be randomly assigned to one of three groups—one group will take iron for several weeks before vaccination, another group will take iron starting on the day of vaccination, and the third group will not take any iron.

Participants in this study can expect to receive three vaccines: the Johnson & Johnson COVID-19 vaccine, the meningococcal vaccine, and the typhoid vaccine. They will also undergo some blood tests to measure their immune response 28 days after vaccination. To take part, women must be willing to give consent and meet certain health criteria, such as not having any major chronic diseases or recent vaccinations. This trial is important because it aims to improve vaccine effectiveness, which can lead to better health outcomes for women in this region.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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