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

Not Applicable

Recruiting

• Conditions: Iron Deficiency Anemia

• 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

Study Timeline

• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Study Start: 2023-11-01
• Study First Posted: 2023-11-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
Plasma iron	Day 56	iron status
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
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