Iron and Vaccine Response

Not Applicable

Completed

• Conditions: Vaccine Preventable Disease; Vaccine Response Impaired; Iron Deficiency Anemia; Iron Deficiency Anemia Treatment
• Interventions: Dietary Supplement: Ferinject

• Registration Number: NCT04912661
• Lead Sponsor: Swiss Federal Institute of 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 viral vaccines, 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 two intramuscular vaccines (influenza and yellow fever). Vaccine response will be measured 28 and 56 days after vaccine administration in both groups. Group 2 (delayed iron treatment) will receive iron treatment at study end.

Study Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-05-28
• Study Start: 2021-05-29
• Study First Posted: 2021-06-03
• 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
Antibody avidity Index	at 63 days	percentage of antibodies that remain bound to beads
Antibody titers	at 63 days
Seroconversion	at 63 days

Secondary Outcome Measures

Name	Time	Method
Proteomics	day 63	Proteins involved in immune response
C-reactive protein	day 63	inflammation status parameter
retinol binding protein	day 63	marker for Vitamin A status
immune cell populations	day 63	number and type of immune cells
Immune cell cytokine secretion	day 35	ELISpot
antiviral immunoglobulin G response	day 63	Immunoassay
Hemoglobin	day 63	iron status parameter
plasma zinc	day 63
Transcriptomics	day 63	Genes involved in immune response
Plasma Ferritin	day 63	iron status parameter
Transferrin saturation	day 63	iron status parameter
Transferrin receptor	day 63	iron status parameter
Alpha-glycoprotein	day 56	inflammation status parameter

Trial Locations

Locations (1)

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