COVID-19 Vaccine, Iron Deficiency Anemia, Iron Deficiency Anemia Treatment, 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 the COVID-19 vaccine, 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 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.
Interventions
DIETARY_SUPPLEMENTFerinject
intravenous iron carboxymaltose
Sponsors
Jomo Kenyatta University of Agriculture and 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 | day 35 | — |
| Seroconversion | day 35 | — |
| Antibody avidity index | day 35 | 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 antiviral immunoglobulin G response antiviral immunoglobulin G response 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 | vitamin A status marker |
| plasma zinc | day 35 | — |
| 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