Iron and Vaccine Response
Iron and Vaccine-preventable Viral Disease - an Experimental Study
1 other identifier
interventional
121
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2021
CompletedStudy Start
First participant enrolled
May 29, 2021
CompletedFirst Posted
Study publicly available on registry
June 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2021
CompletedSeptember 14, 2021
September 1, 2021
3 months
May 28, 2021
September 10, 2021
Conditions
Outcome Measures
Primary Outcomes (6)
Antibody titers
at 35 days
Antibody titers
at 63 days
Seroconversion
at 35 days
Seroconversion
at 63 days
Antibody avidity Index
percentage of antibodies that remain bound to beads
at 35 days
Antibody avidity Index
percentage of antibodies that remain bound to beads
at 63 days
Secondary Outcomes (50)
antiviral immunoglobulin G response
day 0
antiviral immunoglobulin G response
day 7
antiviral immunoglobulin G response
day 35
antiviral immunoglobulin G response
day 63
immune cell populations
day 0
- +45 more secondary outcomes
Study Arms (2)
Immediate iron treatment
ACTIVE COMPARATORintravenous iron carboxymaltose before vaccination
No iron treatment
NO INTERVENTIONno intravenous iron carboxymaltose before vaccination
Interventions
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Msambweni County Referral Hospital
Msambweni, Kwale County, Kenya
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicole Stoffel, PhD
ETH Zurich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 28, 2021
First Posted
June 3, 2021
Study Start
May 29, 2021
Primary Completion
September 9, 2021
Study Completion
September 9, 2021
Last Updated
September 14, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share