Iron and Vaccine Response

Swiss Federal Institute of 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 viral vaccines, and whether iron treatment improves their response.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

121

Conditions

Iron Deficiency Anemia Vaccine Preventable Disease Vaccine Response Impaired 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: at 35 days

Antibody titers

Time frame: at 63 days

Seroconversion

Time frame: at 35 days

Seroconversion

Time frame: at 63 days

Antibody avidity Index

percentage of antibodies that remain bound to beads

Time frame: at 35 days

Antibody avidity Index

percentage of antibodies that remain bound to beads

Time frame: at 63 days

Secondary Outcomes

antiviral immunoglobulin G response

Immunoassay

Time frame: day 0

antiviral immunoglobulin G response

Immunoassay

Time frame: day 7

antiviral immunoglobulin G response

Immunoassay

Time frame: day 35

antiviral immunoglobulin G response

Immunoassay

Time frame: day 63

immune cell populations

number and type of immune cells

Data from ClinicalTrials.gov

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