Iron and 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 viral vaccines, 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 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.

Official Title
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Iron and Vaccine-preventable Viral Disease - an Experimental Study

Conditions
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Iron Deficiency Anemia, Vaccine Preventable Disease, 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 |  | at 35 days | 
| Antibody titers |  | at 63 days | 
| Seroconversion |  | at 35 days | 
| Seroconversion |  | at 63 days | 
| Antibody avidity Index | percentage of antibodies that remain bound to beads | at 35 days | 
| Antibody avidity Index | percentage of antibodies that remain bound to beads | at 63 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| antiviral immunoglobulin G response | Immunoassay | day 0 | 
| antiviral immunoglobulin G response | Immunoassay | day 7 | 
| antiviral immunoglobulin G response | Immunoassay | day 35 | 
| 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 | day 63 | 
| 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 28 | 
| Alpha-glycoprotein | inflammation status parameter | day 56 | 
| retinol binding protein | marker for Vitamin A status | day 0 | 
| retinol binding protein | marker for Vitamin A status | day 7 | 
| retinol binding protein | marker for Vitamin A status | day 35 | 
| retinol binding protein | marker for Vitamin A status | day 63 | 
| plasma zinc |  | day 0 | 
| plasma zinc |  | day 7 | 
| plasma zinc |  | day 35 | 
| plasma zinc |  | day 63 |