Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women
- Conditions
- Iron Deficiency Anemia
- Interventions
- Dietary Supplement: Iron supplementationBiological: MenACWY vaccineBiological: COVID-19 vaccineOther: PlaceboBiological: Typhim Vi vaccine
- Registration Number
- NCT06116669
- Lead Sponsor
- Swiss Federal Institute of Technology
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 180
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Iron supplementation Participants assigned to this group will receive placebo daily on study days 1-56. Control group Placebo Participants assigned to this group will receive placebo daily on study days 1-56. Control group Typhim Vi vaccine Participants assigned to this group will receive placebo daily on study days 1-56. Pre-treatment group Iron supplementation Participants assigned to this group will receive 100 mg oral iron daily on study days 1-56. Pre-treatment group Typhim Vi vaccine Participants assigned to this group will receive 100 mg oral iron daily on study days 1-56. Simultaneous treatment group COVID-19 vaccine Participants assigned to this group will receive placebo daily on study days 1-28 and 100 mg oral iron daily on study days 29-56. Simultaneous treatment group Typhim Vi vaccine Participants assigned to this group will receive placebo daily on study days 1-28 and 100 mg oral iron daily on study days 29-56. Control group MenACWY vaccine Participants assigned to this group will receive placebo daily on study days 1-56. Control group COVID-19 vaccine Participants assigned to this group will receive placebo daily on study days 1-56. Pre-treatment group COVID-19 vaccine Participants assigned to this group will receive 100 mg oral iron daily on study days 1-56. Simultaneous treatment group MenACWY vaccine Participants assigned to this group will receive placebo daily on study days 1-28 and 100 mg oral iron daily on study days 29-56. Pre-treatment group MenACWY vaccine Participants assigned to this group will receive 100 mg oral iron daily on study days 1-56. Simultaneous treatment group Iron supplementation Participants assigned to this group will receive placebo daily on study days 1-28 and 100 mg oral iron daily on study days 29-56. Simultaneous treatment group Placebo Participants assigned to this group will receive placebo daily on study days 1-28 and 100 mg oral iron daily on study days 29-56.
- Primary Outcome Measures
Name Time Method JJ COVID-19 vaccine response Day 56 Anti-spike (S1) IgG and anti-receptor-binding domain (RBD) IgG against SARS-COV-2
MenACWY vaccine response Day 56 Measurement of antibody response against serogroups A, C, W, and Y.
Typhoid vaccine response Day 56 Measurement of antibody response against Typhoid
- Secondary Outcome Measures
Name Time Method Hemoglobin Day 56 iron status
Serum ferritin Day 56 iron status
soluble transferrin receptor Day 56 iron status
alpha- 1- glycoprotein Day 56 inflammation status
Typhim Vi specific B-cell response Day 56 ELISpot assay on isolated peripheral blood mononuclear cells
Plasma iron Day 56 iron status
Retinol binding protein Day 56 Vitamin A status
Total iron binding capacity Day 56 iron status
Transferrin saturation Day 56 iron status
C- reactive protein Day 56 inflammation status
Plasma zinc Day 1 Zinc status
COVID-19 specific T cell response Day 56 ELISpot assay on isolated peripheral blood mononuclear cells
Trial Locations
- Locations (1)
Jomo Kenyatta University Of Agriculture And Technology
🇰🇪Nairobi, Kenya