Iron-fortified food to enhance vaccine response for Japanese encephalitis and typhoid fever
Iron Fortified Food to Improve Japanese Encephalitis and Typhoid Fever Vaccine Immunogenicity: a Randomized Controlled Trial in Iron Deficient Thai Women
This study tests if eating iron-fortified cookies can help women with iron deficiency anemia respond better to vaccines for Japanese encephalitis and typhoid fever.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 49 Years |
| Sex | Female |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Roi Et) |
| Trial ID | NCT06027801 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of iron-fortified cookies on the immune response to Japanese encephalitis and typhoid fever vaccines in women aged 18-49 with iron deficiency anemia. It aims to determine whether improving iron status can enhance vaccine efficacy, particularly in low- and middle-income countries where undernutrition is prevalent. Participants will receive either iron-fortified or non-fortified cookies alongside the vaccines to assess the differences in immune response. The study is conducted in Thailand, where these diseases are endemic.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-49 diagnosed with iron deficiency anemia but not severe anemia.
Not a fit: Patients who are pregnant, lactating, or have major chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve vaccine responses in individuals with iron deficiency anemia, leading to better protection against serious infections.
How similar studies have performed: Other studies have shown that improving iron status can enhance vaccine responses, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the trial. * Female aged 18-49 years. * Diagnosed with anaemia (i.e. hemoglobin (Hb) concentration \<12 g/dl), but no severe anaemia (Hb \<8 g/dl), and iron deficiency (ZnPP \>40 µmol/mol) * Anticipated residence in the area for the study duration Exclusion Criteria: * Pregnant (confirmed by rapid test during screening and at time of vaccination), lactating or planning pregnancy during the trial. * Blood transfusion or intravenous iron treatment within 4 months of study start * Major chronic infectious disease (e.g., tuberculosis, HIV+, hepatitis) * Major chronic non-infectious disease (e.g., Type 1 or 2 diabetes, cancer) * Treatment with supplemental iron two weeks prior to enrolment * JE or typhoid vaccine within the past two years
Where this trial is running
Roi Et
- Mahidol University — Roi Et, Thailand (Recruiting)
Study contacts
- Study coordinator: Nicole Stoffel, PhD
- Email: nicole.stoffel@rdm.ox.ac.uk
- Phone: 044 632 83 93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.