Iron and COVID-19 Vaccine Response

Jomo Kenyatta University of Agriculture and Technology121 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

121

Conditions

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

Interventions

FerinjectDIETARY_SUPPLEMENT

intravenous iron carboxymaltose

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (1)

Msambweni County Referral Hospital

Msambweni, Kwale County, Kenya

Outcomes

Primary Outcomes

Antibody titers

Time frame: day 35

Antibody titers

Time frame: day 63

Seroconversion

Time frame: day 35

Seroconversion

Time frame: day 63

Antibody avidity index

percentage of antibodies that remain bound to beads

Time frame: day 35

Antibody avidity index

percentage of antibodies that remain bound to beads

Time frame: day 63

Secondary Outcomes

antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response

immunoassay

Time frame: day 0

antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response

immunoassay

Time frame: day 7

antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response

immunoassay

Time frame: day 35

antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response

Data from ClinicalTrials.gov

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