Iron and COVID-19 Vaccine Response

Not Applicable

Completed

• Conditions: Iron Deficiency Anemia Treatment; Vaccine Response Impaired; Iron Deficiency Anemia; COVID-19 Vaccine
• Interventions: Dietary Supplement: Ferinject

• Registration Number: NCT04915820
• Lead Sponsor: Jomo Kenyatta University of Agriculture and Technology

Brief Summary

Vaccines often underperform in Africa compared to high-income countries. Why vaccines do not work as well in Africa remains uncertain. Malnutrition likely plays a role. Our study objective is to assess whether iron deficiency anaemia in young women impairs their immune response to the COVID-19 vaccine, and whether iron treatment improves their response.

Detailed Description

Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in both groups will receive the 1st dose of the COVID-19 vaccine. Vaccine response will be measured 28 and 56 days after the first vaccine administration in both groups. At 28 days, participants will receive the 2nd dose of the COVID-19 vaccine. Group 2 (delayed iron treatment) will receive iron treatment at study end.

Study Timeline

• Study First Submitted: 2021-05-28
• Study Start: 2021-05-29
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-07
• Status Verified: 2021-09
• Primary Completion: 2021-09-09
• Study Completion: 2021-09-09
• Last Update Submitted: 2021-09-10
• Last Update Posted: 2021-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

Inclusion Criteria

18-55 years old Zinc protoporphyrin > or equal 40 mmol/mol heme hemoglobin < or equal 109 g/L no malaria no known HIV infection no medical condition that precludes study involvement no iron supplementation 1 week prior to study start no recent tuberculosis infection no vaccination of yellow fever or influenza prior to enrolment not pregnant

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Immediate iron treatment	Ferinject	intravenous iron carboxymaltose before vaccination

Primary Outcome Measures

Name	Time	Method
Seroconversion	day 63
Antibody avidity index	day 63	percentage of antibodies that remain bound to beads
Antibody titers	day 63

Secondary Outcome Measures

Name	Time	Method
Transcriptomics	day 63	Genes involved in immune response
Immune cell cytokine secretion	day 35	ELISpot
Transferrin saturation	day 63	iron status parameter
immune cell populations	day63	number and type of immune cells
Proteomics	day 63	Proteins involved in immune response
Hemoglobin	day 63	iron status parameter
Transferrin receptor	day 63	iron status parameter
retinol binding protein	day 63	vitamin A status marker
plasma zinc	day 35
Plasma ferritin	day 63	iron status parameter
C-reactive protein	day 63	inflammation status parameter
Alpha-glycoprotein	day 63	inflammation status parameter
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response	day 63	immunoassay

Trial Locations

Locations (1)

Msambweni County Referral Hospital; 🇰🇪 Msambweni, Kwale, Kenya