Iron and COVID-19 Vaccine Response

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-29

Study Completion Date

2021-09-09

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Immediate iron treatment

intravenous iron carboxymaltose before vaccination

Group Type ACTIVE_COMPARATOR

Ferinject

Intervention Type DIETARY_SUPPLEMENT

intravenous iron carboxymaltose

No iron treatment

no intravenous iron carboxymaltose before vaccination

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ferinject

intravenous iron carboxymaltose

Intervention Type DIETARY_SUPPLEMENT

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