Iron and COVID-19 Vaccine Response

Iron and Vaccine-preventable Viral Disease

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia; COVID-19 Vaccine; Iron Deficiency Anemia Treatment; Vaccine Response Impaired
• Intervention / Treatment: Dietary supplement: Ferinject

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kwale
    • Msambweni, Kwale, Kenya
      • Msambweni County Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Immediate iron treatment; intravenous iron carboxymaltose before vaccination	Dietary supplement: Ferinject; intravenous iron carboxymaltose
No Intervention: No iron treatment; no intravenous iron carboxymaltose before vaccination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody titers		day 35
Antibody titers		day 63
Seroconversion		day 35
Seroconversion		day 63
Antibody avidity index	percentage of antibodies that remain bound to beads	day 35
Antibody avidity index	percentage of antibodies that remain bound to beads	day 63

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response	immunoassay	day 0
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response	immunoassay	day 7
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response	immunoassay	day 35
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response	immunoassay	day 63
immune cell populations	number and type of immune cells	day 0
immune cell populations	number and type of immune cells	day 7
immune cell populations	number and type of immune cells	day 35
immune cell populations	number and type of immune cells	day63
Proteomics	Proteins involved in immune response	day 0
Proteomics	Proteins involved in immune response	day 7
Proteomics	Proteins involved in immune response	day 35
Proteomics	Proteins involved in immune response	day 63
Transcriptomics	Genes involved in immune response	day 0
Transcriptomics	Genes involved in immune response	day 7
Transcriptomics	Genes involved in immune response	day 35
Transcriptomics	Genes involved in immune response	day 63
Immune cell cytokine secretion	ELISpot	day 7
Immune cell cytokine secretion	ELISpot	day 35
Hemoglobin	iron status parameter	day 0
Hemoglobin	iron status parameter	day 7
Hemoglobin	iron status parameter	day 35
Hemoglobin	iron status parameter	day 63
Plasma ferritin	iron status parameter	day 0
Plasma ferritin	iron status parameter	day 7
Plasma ferritin	iron status parameter	day 35
Plasma ferritin	iron status parameter	day 63
Transferrin receptor	iron status parameter	day 0
Transferrin receptor	iron status parameter	day 7
Transferrin receptor	iron status parameter	day 35
Transferrin receptor	iron status parameter	day 63
Transferrin saturation	iron status parameter	day 0
Transferrin saturation	iron status parameter	day 7
Transferrin saturation	iron status parameter	day 35
Transferrin saturation	iron status parameter	day 63
C-reactive protein	inflammation status parameter	day 0
C-reactive protein	inflammation status parameter	day 7
C-reactive protein	inflammation status parameter	day 35
C-reactive protein	inflammation status parameter	day 63
Alpha-glycoprotein	inflammation status parameter	day 0
Alpha-glycoprotein	inflammation status parameter	day 7
Alpha-glycoprotein	inflammation status parameter	day 35
Alpha-glycoprotein	inflammation status parameter	day 63
retinol binding protein	vitamin A status marker	day 0
retinol binding protein	vitamin A status marker	day 7
retinol binding protein	vitamin A status marker	day 35
retinol binding protein	vitamin A status marker	day 63
plasma zinc		day 35

Collaborators and Investigators

• Sponsor: Jomo Kenyatta University of Agriculture and Technology
• Investigators: Principal Investigator: Simon Karanja, PhD, JKUAT Nairobi

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2021
• Primary Completion (Actual): September 9, 2021
• Study Completion (Actual): September 9, 2021

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; COVID-19; Anemia, Iron-Deficiency; Anemia; Deficiency Diseases
• Other Study ID Numbers: DIVA II

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No