Clinical trial NCT04912661: Iron and Vaccine Response
Official title: Iron and Vaccine-preventable Viral Disease - an Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Vaccine Preventable Disease
Vaccine Response Impaired
Iron Deficiency Anemia Treatment
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Jomo Kenyatta University of Agriculture and Technology
First posted: 2021-06-03
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Antibody titers
timeFrame: at 35 days
measure: Antibody titers
timeFrame: at 63 days
measure: Seroconversion
timeFrame: at 35 days
measure: Seroconversion
timeFrame: at 63 days
measure: Antibody avidity Index
timeFrame: at 35 days
measure: Antibody avidity Index
timeFrame: at 63 days
Secondary outcomes:
measure: antiviral immunoglobulin G response
timeFrame: day 0
measure: antiviral immunoglobulin G response
timeFrame: day 7
measure: antiviral immunoglobulin G response
timeFrame: day 35
measure: antiviral immunoglobulin G response
timeFrame: day 63
measure: immune cell populations
timeFrame: day 0
measure: immune cell populations
timeFrame: day 7
measure: immune cell populations
timeFrame: day 35
measure: immune cell populations
timeFrame: day 63
measure: Proteomics
timeFrame: day 0
measure: Proteomics
timeFrame: day 7
measure: Proteomics
timeFrame: day 35
measure: Proteomics
timeFrame: day 63
measure: Transcriptomics
timeFrame: day 0
measure: Transcriptomics
timeFrame: day 7
measure: Transcriptomics
timeFrame: day 35
measure: Transcriptomics
timeFrame: day 63
measure: Immune cell cytokine secretion
timeFrame: day 7
measure: Immune cell cytokine secretion
timeFrame: day 35
measure: Hemoglobin
timeFrame: day 0
measure: Hemoglobin
timeFrame: day 7
measure: Hemoglobin
timeFrame: day 35
measure: Hemoglobin
timeFrame: day 63
measure: Plasma Ferritin
timeFrame: day 0
measure: Plasma Ferritin
timeFrame: day 7
measure: Plasma Ferritin
timeFrame: day 35
measure: Plasma Ferritin
timeFrame: day 63
measure: Transferrin receptor
timeFrame: day 0
measure: Transferrin receptor
timeFrame: day 7
measure: Transferrin receptor
timeFrame: day 35
measure: Transferrin receptor
timeFrame: day 63
measure: Transferrin saturation
timeFrame: day 0
measure: Transferrin saturation
timeFrame: day 7
measure: Transferrin saturation
timeFrame: day 35
measure: Transferrin saturation
timeFrame: day 63
measure: C-reactive protein
timeFrame: day 0
measure: C-reactive protein
timeFrame: day 7
measure: C-reactive protein
timeFrame: day 35
measure: C-reactive protein
timeFrame: day 63
measure: Alpha-glycoprotein
timeFrame: day 0
measure: Alpha-glycoprotein
timeFrame: day 7
measure: Alpha-glycoprotein
timeFrame: day 28
measure: Alpha-glycoprotein
timeFrame: day 56
measure: retinol binding protein
timeFrame: day 0
measure: retinol binding protein
timeFrame: day 7
measure: retinol binding protein
timeFrame: day 35
measure: retinol binding protein
timeFrame: day 63
measure: plasma zinc
timeFrame: day 0
measure: plasma zinc
timeFrame: day 7
measure: plasma zinc
timeFrame: day 35
measure: plasma zinc
timeFrame: day 63
Other outcomes:
Locations:
city: Msambweni
country: Kenya
facility: Msambweni County Referral Hospital
state: Kwale
Study officials:
affiliation: ETH Zurich
name: Nicole Stoffel, PhD
role: PRINCIPAL_INVESTIGATOR
References: