Iron and COVID-19 Vaccine Response

Study Overview
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Brief Summary
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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
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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.

Official Title
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Iron and Vaccine-preventable Viral Disease

Conditions
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COVID-19 Vaccine, Iron Deficiency Anemia, Vaccine Response Impaired, Iron Deficiency Anemia Treatment

Intervention / Treatment
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* Dietary Supplement: Ferinject


Participation Criteria
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Eligibility Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Immediate iron treatment<br>intravenous iron carboxymaltose before vaccination | Dietary Supplement: Ferinject<br>* intravenous iron carboxymaltose<br>|
| No Intervention: No iron treatment<br>no intravenous iron carboxymaltose before vaccination | |

What is the study measuring?
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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 |