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CompletedNCT04915820Updated Sep 4, 2025

Iron and COVID-19 Vaccine Response

An interventional study of Ferinject in Iron Deficiency Anemia, Vaccine Response Impaired and COVID-19 Vaccine, sponsored by Jomo Kenyatta University of Agriculture and Technology. Completed at 1 site in Kenya. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-04.

Sponsored by Jomo Kenyatta University of Agriculture and Technology · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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 the COVID-19 vaccine, and whether iron treatment improves their response.

Read the detailed description

Group 1 (immediate iron treatment) will receive iron treatment before vaccination. Women in both groups will receive the 1st dose of the COVID-19 vaccine. Vaccine response will be measured 28 and 56 days after the first vaccine administration in both groups. At 28 days, participants will receive the 2nd dose of the COVID-19 vaccine. Group 2 (delayed iron treatment) will receive iron treatment at study end.

02

Conditions studied

  • Iron Deficiency Anemia
  • Vaccine Response Impaired
  • COVID-19 Vaccine
  • Iron Deficiency Anemia Treatment
03

In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's enrollment of 121 is above the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

Jomo Kenyatta University of Agriculture and Technology is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
121 participants (actual)

Study arms

  • Active comparator
    Immediate iron treatment

    intravenous iron carboxymaltose before vaccination

    Dietary Supplement: Ferinject

  • No intervention
    No iron treatment

    no intravenous iron carboxymaltose before vaccination

Interventions

  • Dietary supplementFerinject

    intravenous iron carboxymaltose

06

What researchers measure

Primary outcomes

  1. Antibody titers

    Time frame: day 35

  2. Antibody titers

    Time frame: day 63

  3. Seroconversion

    Time frame: day 35

  4. Seroconversion

    Time frame: day 63

  5. Antibody avidity index

    percentage of antibodies that remain bound to beads

    Time frame: day 35

  6. Antibody avidity index

    percentage of antibodies that remain bound to beads

    Time frame: day 63

Secondary outcomes

  1. antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response

    immunoassay

    Time frame: day 0

  2. antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response

    immunoassay

    Time frame: day 7

  3. antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response

    immunoassay

    Time frame: day 35

  4. antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response

    immunoassay

    Time frame: day 63

  5. immune cell populations

    number and type of immune cells

    Time frame: day 0

  6. immune cell populations

    number and type of immune cells

    Time frame: day 7

  7. immune cell populations

    number and type of immune cells

    Time frame: day 35

  8. immune cell populations

    number and type of immune cells

    Time frame: day63

  9. Proteomics

    Proteins involved in immune response

    Time frame: day 0

  10. Proteomics

    Proteins involved in immune response

    Time frame: day 7

  11. Proteomics

    Proteins involved in immune response

    Time frame: day 35

  12. Proteomics

    Proteins involved in immune response

    Time frame: day 63

  13. Transcriptomics

    Genes involved in immune response

    Time frame: day 0

  14. Transcriptomics

    Genes involved in immune response

    Time frame: day 7

  15. Transcriptomics

    Genes involved in immune response

    Time frame: day 35

  16. Transcriptomics

    Genes involved in immune response

    Time frame: day 63

  17. Immune cell cytokine secretion

    ELISpot

    Time frame: day 7

  18. Immune cell cytokine secretion

    ELISpot

    Time frame: day 35

  19. Hemoglobin

    iron status parameter

    Time frame: day 0

  20. Hemoglobin

    iron status parameter

    Time frame: day 7

  21. Hemoglobin

    iron status parameter

    Time frame: day 35

  22. Hemoglobin

    iron status parameter

    Time frame: day 63

  23. Plasma ferritin

    iron status parameter

    Time frame: day 0

  24. Plasma ferritin

    iron status parameter

    Time frame: day 7

  25. Plasma ferritin

    iron status parameter

    Time frame: day 35

  26. Plasma ferritin

    iron status parameter

    Time frame: day 63

  27. Transferrin receptor

    iron status parameter

    Time frame: day 0

  28. Transferrin receptor

    iron status parameter

    Time frame: day 7

  29. Transferrin receptor

    iron status parameter

    Time frame: day 35

  30. Transferrin receptor

    iron status parameter

    Time frame: day 63

  31. Transferrin saturation

    iron status parameter

    Time frame: day 0

  32. Transferrin saturation

    iron status parameter

    Time frame: day 7

  33. Transferrin saturation

    iron status parameter

    Time frame: day 35

  34. Transferrin saturation

    iron status parameter

    Time frame: day 63

  35. C-reactive protein

    inflammation status parameter

    Time frame: day 0

  36. C-reactive protein

    inflammation status parameter

    Time frame: day 7

  37. C-reactive protein

    inflammation status parameter

    Time frame: day 35

  38. C-reactive protein

    inflammation status parameter

    Time frame: day 63

  39. Alpha-glycoprotein

    inflammation status parameter

    Time frame: day 0

  40. Alpha-glycoprotein

    inflammation status parameter

    Time frame: day 7

  41. Alpha-glycoprotein

    inflammation status parameter

    Time frame: day 35

  42. Alpha-glycoprotein

    inflammation status parameter

    Time frame: day 63

  43. retinol binding protein

    vitamin A status marker

    Time frame: day 0

  44. retinol binding protein

    vitamin A status marker

    Time frame: day 7

  45. retinol binding protein

    vitamin A status marker

    Time frame: day 35

  46. retinol binding protein

    vitamin A status marker

    Time frame: day 63

  47. plasma zinc

    Time frame: day 35

07

Study locations

1 site
  • Msambweni County Referral Hospital
    Msambweni, Kwale County, Kenya
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04915820
Lead sponsor
Jomo Kenyatta University of Agriculture and Technology
Responsible party
Prof Simon Karanja (PhD, Jomo Kenyatta University of Agriculture and Technology) — Principal investigator
First posted
Jun 7, 2021
Start date
May 29, 2021
Primary completion
Sep 9, 2021
Completion
Sep 9, 2021
Last update
Sep 4, 2025

Study contacts

Simon Karanja, PhD
principal investigator · JKUAT Nairobi

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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