Iron and 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 viral vaccines, 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 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.

Conditions

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Iron Deficiency Anemia Vaccine Preventable Disease Vaccine Response Impaired 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