Effects of Oral Iron Supplementation Before vs at Time of Vaccination on Immune Response in Iron Deficient Kenyan Women
NCT ID: NCT06116669
Last Updated: 2024-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
180 participants
INTERVENTIONAL
2023-11-01
2024-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Pre-treatment group
Participants assigned to this group will receive 100 mg oral iron daily on study days 1-56.
Iron supplementation
Iron supplements as 100 mg oral iron as FeSO4 given daily
MenACWY vaccine
MenACWY vaccination given on day 28 to all participants
COVID-19 vaccine
Johnson \& Johnson COVID- 19 (JJ COVID-19) vaccination given on day 28 to all participants
Typhim Vi vaccine
Typhim Vi vaccination given on day 28 to all participants
Simultaneous treatment group
Participants assigned to this group will receive placebo daily on study days 1-28 and 100 mg oral iron daily on study days 29-56.
Iron supplementation
Iron supplements as 100 mg oral iron as FeSO4 given daily
MenACWY vaccine
MenACWY vaccination given on day 28 to all participants
COVID-19 vaccine
Johnson \& Johnson COVID- 19 (JJ COVID-19) vaccination given on day 28 to all participants
Placebo
matching placebo capsules given daily
Typhim Vi vaccine
Typhim Vi vaccination given on day 28 to all participants
Control group
Participants assigned to this group will receive placebo daily on study days 1-56.
Iron supplementation
Iron supplements as 100 mg oral iron as FeSO4 given daily
MenACWY vaccine
MenACWY vaccination given on day 28 to all participants
COVID-19 vaccine
Johnson \& Johnson COVID- 19 (JJ COVID-19) vaccination given on day 28 to all participants
Placebo
matching placebo capsules given daily
Typhim Vi vaccine
Typhim Vi vaccination given on day 28 to all participants
Interventions
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Iron supplementation
Iron supplements as 100 mg oral iron as FeSO4 given daily
MenACWY vaccine
MenACWY vaccination given on day 28 to all participants
COVID-19 vaccine
Johnson \& Johnson COVID- 19 (JJ COVID-19) vaccination given on day 28 to all participants
Placebo
matching placebo capsules given daily
Typhim Vi vaccine
Typhim Vi vaccination given on day 28 to all participants
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
49 Years
FEMALE
Yes
Sponsors
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Jomo Kenyatta University of Agriculture and Technology
OTHER
University of Oxford
OTHER
Swiss Federal Institute of Technology
OTHER
Responsible Party
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Locations
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Jomo Kenyatta University Of Agriculture And Technology
Nairobi, , Kenya
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DIVA_II
Identifier Type: -
Identifier Source: org_study_id
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