Iron and Vaccine Response

Iron and Vaccine-preventable Viral Disease - an Experimental Study

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia; Vaccine Preventable Disease; Iron Deficiency Anemia Treatment; Vaccine Response Impaired
• Intervention / Treatment: Dietary supplement: Ferinject

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kwale
    • Msambweni, Kwale, Kenya
      • Msambweni County Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibody titers		at 35 days
Antibody titers		at 63 days
Seroconversion		at 35 days
Seroconversion		at 63 days
Antibody avidity Index	percentage of antibodies that remain bound to beads	at 35 days
Antibody avidity Index	percentage of antibodies that remain bound to beads	at 63 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
immune cell populations	number and type of immune cells	day 0
immune cell populations	number and type of immune cells	day 7
immune cell populations	number and type of immune cells	day 35
Proteomics	Proteins involved in immune response	day 0
Proteomics	Proteins involved in immune response	day 7
Proteomics	Proteins involved in immune response	day 35
Proteomics	Proteins involved in immune response	day 63
Transcriptomics	Genes involved in immune response	day 0
Transcriptomics	Genes involved in immune response	day 7
Transcriptomics	Genes involved in immune response	day 35
Transcriptomics	Genes involved in immune response	day 63
Immune cell cytokine secretion	ELISpot	day 7
Immune cell cytokine secretion	ELISpot	day 35
Hemoglobin	iron status parameter	day 0
Hemoglobin	iron status parameter	day 7
Hemoglobin	iron status parameter	day 35
Hemoglobin	iron status parameter	day 63
Transferrin receptor	iron status parameter	day 0
Transferrin receptor	iron status parameter	day 7
Transferrin receptor	iron status parameter	day 35
Transferrin receptor	iron status parameter	day 63
Transferrin saturation	iron status parameter	day 0
Transferrin saturation	iron status parameter	day 7
Transferrin saturation	iron status parameter	day 35
Transferrin saturation	iron status parameter	day 63
C-reactive protein	inflammation status parameter	day 0
C-reactive protein	inflammation status parameter	day 7
C-reactive protein	inflammation status parameter	day 35
C-reactive protein	inflammation status parameter	day 63
Alpha-glycoprotein	inflammation status parameter	day 0
Alpha-glycoprotein	inflammation status parameter	day 7
plasma zinc		day 35
antiviral immunoglobulin G response	Immunoassay	day 0
antiviral immunoglobulin G response	Immunoassay	day 7
antiviral immunoglobulin G response	Immunoassay	day 35
antiviral immunoglobulin G response	Immunoassay	day 63
immune cell populations	number and type of immune cells	day 63
Plasma Ferritin	iron status parameter	day 0
Plasma Ferritin	iron status parameter	day 7
Plasma Ferritin	iron status parameter	day 35
Plasma Ferritin	iron status parameter	day 63
Alpha-glycoprotein	inflammation status parameter	day 28
Alpha-glycoprotein	inflammation status parameter	day 56
retinol binding protein	marker for Vitamin A status	day 0
retinol binding protein	marker for Vitamin A status	day 7
retinol binding protein	marker for Vitamin A status	day 35
retinol binding protein	marker for Vitamin A status	day 63
plasma zinc		day 0
plasma zinc		day 7
plasma zinc		day 63

Collaborators and Investigators

• Sponsor: Swiss Federal Institute of Technology
• Collaborators: Jomo Kenyatta University of Agriculture and Technology
• Investigators: Principal Investigator: Nicole Stoffel, PhD, ETH Zurich

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2021
• Primary Completion (Actual): September 9, 2021
• Study Completion (Actual): September 9, 2021

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: May 28, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Infections; Hematologic Diseases; Nutrition Disorders; Anemia, Hypochromic; Iron Metabolism Disorders; Malnutrition; Anemia, Iron-Deficiency; Anemia; Vaccine-Preventable Diseases; Deficiency Diseases
• Other Study ID Numbers: DIVA I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No