Iron and Vaccine Response

Federal Institute of Technology (ETH) Zurich

Status: Completed

Conditions: Vaccine Preventable Disease; Iron Deficiency Anemia; Vaccine Response Impaired; Iron Deficiency Anemia Treatment

Treatments: Dietary Supplement: Ferinject

Study type: Interventional

Funder types: Other

Identifiers

NCT04912661

DIVA I

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 121 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

121 participants in 2 patient groups

Immediate iron treatment

Active Comparator group

Description:

intravenous iron carboxymaltose before vaccination

Treatment:

Dietary Supplement: Ferinject

No iron treatment

No Intervention group

Description:

no intravenous iron carboxymaltose before vaccination