Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women
DIVA_II
1 other identifier
interventional
180
1 country
1
Brief Summary
Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation. The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination). We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson \& Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJanuary 24, 2024
January 1, 2024
1.2 years
October 30, 2023
January 22, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
JJ COVID-19 vaccine response
Anti-spike (S1) IgG and anti-receptor-binding domain (RBD) IgG against SARS-COV-2
Day 56
MenACWY vaccine response
Measurement of antibody response against serogroups A, C, W, and Y.
Day 56
Typhoid vaccine response
Measurement of antibody response against Typhoid
Day 56
Secondary Outcomes (34)
Hemoglobin
Day 1
Hemoglobin
Day 28
Hemoglobin
Day 56
Serum ferritin
Day 1
Serum ferritin
Day 28
- +29 more secondary outcomes
Study Arms (3)
Pre-treatment group
EXPERIMENTALParticipants assigned to this group will receive 100 mg oral iron daily on study days 1-56.
Simultaneous treatment group
EXPERIMENTALParticipants assigned to this group will receive placebo daily on study days 1-28 and 100 mg oral iron daily on study days 29-56.
Control group
PLACEBO COMPARATORParticipants assigned to this group will receive placebo daily on study days 1-56.
Interventions
Iron supplements as 100 mg oral iron as FeSO4 given daily
MenACWY vaccination given on day 28 to all participants
Johnson \& Johnson COVID- 19 (JJ COVID-19) vaccination given on day 28 to all participants
Typhim Vi vaccination given on day 28 to all participants
Eligibility Criteria
You may qualify if:
- Willing and able to give informed consent for participation in the trial
- Female aged 18-49 years
- Moderate anemia (Hb \<110 g/L, but not severely anemic with Hb \<80 g/L)
- Iron deficient (ZnPP \>40 mmol/mol haem)
- Anticipated residence in the study area for the study duration
You may not qualify if:
- Major chronic infecious disease (e.g., HIV infection);
- Major chronic non-infecious disease (e.g., Type 2 diabetes, cancer);
- Chronic medications;
- Use of iron-containing mineral and vitamin supplementation 2 weeks prior to study start;
- COVID-19 vaccine or confirmed COVID-19 infection within the past 2 years
- MenACWY vaccine in the past
- Typhim Vi vaccine in the past
- Pregnant (confirmed by rapid test during screening)
- Malaria (confirmed by rapid test) à study start will be postponed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Swiss Federal Institute of Technologylead
- Jomo Kenyatta University of Agriculture and Technologycollaborator
- University of Oxfordcollaborator
Study Sites (1)
Jomo Kenyatta University Of Agriculture And Technology
Nairobi, 00200, Kenya
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2023
First Posted
November 3, 2023
Study Start
November 1, 2023
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
January 24, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share