Iron Deficiency Anemia, Iron Deficiency Anemia Treatment, Vaccine Preventable Disease, Vaccine Response Impaired
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFerinject
intravenous iron carboxymaltose
Sponsors
Jomo Kenyatta University of Agriculture and Technology
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody titers | at 35 days | — |
| Seroconversion | at 35 days | — |
| Antibody avidity Index | at 35 days | percentage of antibodies that remain bound to beads |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transcriptomics | day 0 | Genes involved in immune response |
| Immune cell cytokine secretion | day 7 | ELISpot |
| Hemoglobin | day 0 | iron status parameter |
| Plasma Ferritin | day 0 | iron status parameter |
| Transferrin receptor | day 0 | iron status parameter |
| antiviral immunoglobulin G response | day 0 | Immunoassay |
| C-reactive protein | day 0 | inflammation status parameter |
| Alpha-glycoprotein | day 0 | inflammation status parameter |
| retinol binding protein | day 0 | marker for Vitamin A status |
| plasma zinc | day 0 | — |
| Transferrin saturation | day 0 | iron status parameter |
| immune cell populations | day 0 | number and type of immune cells |
| Proteomics | day 0 | Proteins involved in immune response |
Countries
Kenya
Outcome results
None listed