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Iron and Vaccine Response

Sponsor
Swiss Federal Institute of Technology (Other)
Overall Status
Completed
CT.gov ID
NCT04912661
Collaborator
Jomo Kenyatta University of Agriculture and Technology (Other)
121
Enrollment
1
Location
2
Arms
3.4
Actual Duration (Months)
35.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Ferinject
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Iron and Vaccine-preventable Viral Disease - an Experimental Study
Actual Study Start Date :
May 29, 2021
Actual Primary Completion Date :
Sep 9, 2021
Actual Study Completion Date :
Sep 9, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Immediate iron treatment

intravenous iron carboxymaltose before vaccination

Dietary Supplement: Ferinject
intravenous iron carboxymaltose
No Intervention: No iron treatment

no intravenous iron carboxymaltose before vaccination

Outcome Measures

Primary Outcome Measures

  1. Antibody titers [at 35 days]

  2. Antibody titers [at 63 days]

  3. Seroconversion [at 35 days]

  4. Seroconversion [at 63 days]

  5. Antibody avidity Index [at 35 days]

    percentage of antibodies that remain bound to beads

  6. Antibody avidity Index [at 63 days]

    percentage of antibodies that remain bound to beads

Secondary Outcome Measures

  1. antiviral immunoglobulin G response [day 0]

    Immunoassay

  2. antiviral immunoglobulin G response [day 7]

    Immunoassay

  3. antiviral immunoglobulin G response [day 35]

    Immunoassay

  4. antiviral immunoglobulin G response [day 63]

    Immunoassay

  5. immune cell populations [day 0]

    number and type of immune cells

  6. immune cell populations [day 7]

    number and type of immune cells

  7. immune cell populations [day 35]

    number and type of immune cells

  8. immune cell populations [day 63]

    number and type of immune cells

  9. Proteomics [day 0]

    Proteins involved in immune response

  10. Proteomics [day 7]

    Proteins involved in immune response

  11. Proteomics [day 35]

    Proteins involved in immune response

  12. Proteomics [day 63]

    Proteins involved in immune response

  13. Transcriptomics [day 0]

    Genes involved in immune response

  14. Transcriptomics [day 7]

    Genes involved in immune response

  15. Transcriptomics [day 35]

    Genes involved in immune response

  16. Transcriptomics [day 63]

    Genes involved in immune response

  17. Immune cell cytokine secretion [day 7]

    ELISpot

  18. Immune cell cytokine secretion [day 35]

    ELISpot

  19. Hemoglobin [day 0]

    iron status parameter

  20. Hemoglobin [day 7]

    iron status parameter

  21. Hemoglobin [day 35]

    iron status parameter

  22. Hemoglobin [day 63]

    iron status parameter

  23. Plasma Ferritin [day 0]

    iron status parameter

  24. Plasma Ferritin [day 7]

    iron status parameter

  25. Plasma Ferritin [day 35]

    iron status parameter

  26. Plasma Ferritin [day 63]

    iron status parameter

  27. Transferrin receptor [day 0]

    iron status parameter

  28. Transferrin receptor [day 7]

    iron status parameter

  29. Transferrin receptor [day 35]

    iron status parameter

  30. Transferrin receptor [day 63]

    iron status parameter

  31. Transferrin saturation [day 0]

    iron status parameter

  32. Transferrin saturation [day 7]

    iron status parameter

  33. Transferrin saturation [day 35]

    iron status parameter

  34. Transferrin saturation [day 63]

    iron status parameter

  35. C-reactive protein [day 0]

    inflammation status parameter

  36. C-reactive protein [day 7]

    inflammation status parameter

  37. C-reactive protein [day 35]

    inflammation status parameter

  38. C-reactive protein [day 63]

    inflammation status parameter

  39. Alpha-glycoprotein [day 0]

    inflammation status parameter

  40. Alpha-glycoprotein [day 7]

    inflammation status parameter

  41. Alpha-glycoprotein [day 28]

    inflammation status parameter

  42. Alpha-glycoprotein [day 56]

    inflammation status parameter

  43. retinol binding protein [day 0]

    marker for Vitamin A status

  44. retinol binding protein [day 7]

    marker for Vitamin A status

  45. retinol binding protein [day 35]

    marker for Vitamin A status

  46. retinol binding protein [day 63]

    marker for Vitamin A status

  47. plasma zinc [day 0]

  48. plasma zinc [day 7]

  49. plasma zinc [day 35]

  50. plasma zinc [day 63]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Msambweni County Referral Hospital Msambweni Kwale Kenya

Sponsors and Collaborators

  • Swiss Federal Institute of Technology
  • Jomo Kenyatta University of Agriculture and Technology

Investigators

  • Principal Investigator: Nicole Stoffel, PhD, ETH Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nicole Stoffel, PhD, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT04912661
Other Study ID Numbers:
  • DIVA I
First Posted:
Jun 3, 2021
Last Update Posted:
Sep 14, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Vaccine-Preventable Diseases
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases

Study Results

No Results Posted as of Sep 14, 2021