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OpenTrials
Completed

NCT Number: NCT04912661

Iron and Vaccine Response

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.

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Key information

Conditions

Iron Deficiency Anemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Infections Iron Deficiencies Iron Deficiency Anemia Treatment Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vaccine Preventable Disease Vaccine Response Impaired Vaccine-Preventable Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Msambweni County Referral Hospital

Msambweni, Kwale County, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Ferinject

Dietary Supplement

intravenous iron carboxymaltose

Primary outcomes

  1. Antibody titers

    Time frame: at 35 days

  2. Antibody titers

    Time frame: at 63 days

  3. Seroconversion

    Time frame: at 35 days

  4. Seroconversion

    Time frame: at 63 days

  5. Antibody avidity Index

    Time frame: at 35 days

    percentage of antibodies that remain bound to beads

  6. Antibody avidity Index

    Time frame: at 63 days

    percentage of antibodies that remain bound to beads

Secondary outcomes

  1. antiviral immunoglobulin G response

    Time frame: day 0

    Immunoassay

  2. antiviral immunoglobulin G response

    Time frame: day 7

    Immunoassay

  3. antiviral immunoglobulin G response

    Time frame: day 35

    Immunoassay

  4. antiviral immunoglobulin G response

    Time frame: day 63

    Immunoassay

  5. immune cell populations

    Time frame: day 0

    number and type of immune cells

  6. immune cell populations

    Time frame: day 7

    number and type of immune cells

  7. immune cell populations

    Time frame: day 35

    number and type of immune cells

  8. immune cell populations

    Time frame: day 63

    number and type of immune cells

  9. Proteomics

    Time frame: day 0

    Proteins involved in immune response

  10. Proteomics

    Time frame: day 7

    Proteins involved in immune response

  11. Proteomics

    Time frame: day 35

    Proteins involved in immune response

  12. Proteomics

    Time frame: day 63

    Proteins involved in immune response

  13. Transcriptomics

    Time frame: day 0

    Genes involved in immune response

  14. Transcriptomics

    Time frame: day 7

    Genes involved in immune response

  15. Transcriptomics

    Time frame: day 35

    Genes involved in immune response

  16. Transcriptomics

    Time frame: day 63

    Genes involved in immune response

  17. Immune cell cytokine secretion

    Time frame: day 7

    ELISpot

  18. Immune cell cytokine secretion

    Time frame: day 35

    ELISpot

  19. Hemoglobin

    Time frame: day 0

    iron status parameter

  20. Hemoglobin

    Time frame: day 7

    iron status parameter

  21. Hemoglobin

    Time frame: day 35

    iron status parameter

  22. Hemoglobin

    Time frame: day 63

    iron status parameter

  23. Plasma Ferritin

    Time frame: day 0

    iron status parameter

  24. Plasma Ferritin

    Time frame: day 7

    iron status parameter

  25. Plasma Ferritin

    Time frame: day 35

    iron status parameter

  26. Plasma Ferritin

    Time frame: day 63

    iron status parameter

  27. Transferrin receptor

    Time frame: day 0

    iron status parameter

  28. Transferrin receptor

    Time frame: day 7

    iron status parameter

  29. Transferrin receptor

    Time frame: day 35

    iron status parameter

  30. Transferrin receptor

    Time frame: day 63

    iron status parameter

  31. Transferrin saturation

    Time frame: day 0

    iron status parameter

  32. Transferrin saturation

    Time frame: day 7

    iron status parameter

  33. Transferrin saturation

    Time frame: day 35

    iron status parameter

  34. Transferrin saturation

    Time frame: day 63

    iron status parameter

  35. C-reactive protein

    Time frame: day 0

    inflammation status parameter

  36. C-reactive protein

    Time frame: day 7

    inflammation status parameter

  37. C-reactive protein

    Time frame: day 35

    inflammation status parameter

  38. C-reactive protein

    Time frame: day 63

    inflammation status parameter

  39. Alpha-glycoprotein

    Time frame: day 0

    inflammation status parameter

  40. Alpha-glycoprotein

    Time frame: day 7

    inflammation status parameter

  41. Alpha-glycoprotein

    Time frame: day 28

    inflammation status parameter

  42. Alpha-glycoprotein

    Time frame: day 56

    inflammation status parameter

  43. retinol binding protein

    Time frame: day 0

    marker for Vitamin A status

  44. retinol binding protein

    Time frame: day 7

    marker for Vitamin A status

  45. retinol binding protein

    Time frame: day 35

    marker for Vitamin A status

  46. retinol binding protein

    Time frame: day 63

    marker for Vitamin A status

  47. plasma zinc

    Time frame: day 0

  48. plasma zinc

    Time frame: day 7

  49. plasma zinc

    Time frame: day 35

  50. plasma zinc

    Time frame: day 63

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • Jomo Kenyatta University of Agriculture and Technology

Registry information

Official study title

Iron and Vaccine-preventable Viral Disease - an Experimental Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 3, 2021
Registry last updated
Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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