search
Back to results

Iron and Vaccine Response

Primary Purpose

Iron Deficiency Anemia, Vaccine Preventable Disease, Vaccine Response Impaired

Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Ferinject
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Iron Deficiency Anemia

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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:

-

Sites / Locations

  • Msambweni County Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Immediate iron treatment

No iron treatment

Arm Description

intravenous iron carboxymaltose before vaccination

no intravenous iron carboxymaltose before vaccination

Outcomes

Primary Outcome Measures

Antibody titers
Antibody titers
Seroconversion
Seroconversion
Antibody avidity Index
percentage of antibodies that remain bound to beads
Antibody avidity Index
percentage of antibodies that remain bound to beads

Secondary Outcome Measures

antiviral immunoglobulin G response
Immunoassay
antiviral immunoglobulin G response
Immunoassay
antiviral immunoglobulin G response
Immunoassay
antiviral immunoglobulin G response
Immunoassay
immune cell populations
number and type of immune cells
immune cell populations
number and type of immune cells
immune cell populations
number and type of immune cells
immune cell populations
number and type of immune cells
Proteomics
Proteins involved in immune response
Proteomics
Proteins involved in immune response
Proteomics
Proteins involved in immune response
Proteomics
Proteins involved in immune response
Transcriptomics
Genes involved in immune response
Transcriptomics
Genes involved in immune response
Transcriptomics
Genes involved in immune response
Transcriptomics
Genes involved in immune response
Immune cell cytokine secretion
ELISpot
Immune cell cytokine secretion
ELISpot
Hemoglobin
iron status parameter
Hemoglobin
iron status parameter
Hemoglobin
iron status parameter
Hemoglobin
iron status parameter
Plasma Ferritin
iron status parameter
Plasma Ferritin
iron status parameter
Plasma Ferritin
iron status parameter
Plasma Ferritin
iron status parameter
Transferrin receptor
iron status parameter
Transferrin receptor
iron status parameter
Transferrin receptor
iron status parameter
Transferrin receptor
iron status parameter
Transferrin saturation
iron status parameter
Transferrin saturation
iron status parameter
Transferrin saturation
iron status parameter
Transferrin saturation
iron status parameter
C-reactive protein
inflammation status parameter
C-reactive protein
inflammation status parameter
C-reactive protein
inflammation status parameter
C-reactive protein
inflammation status parameter
Alpha-glycoprotein
inflammation status parameter
Alpha-glycoprotein
inflammation status parameter
Alpha-glycoprotein
inflammation status parameter
Alpha-glycoprotein
inflammation status parameter
retinol binding protein
marker for Vitamin A status
retinol binding protein
marker for Vitamin A status
retinol binding protein
marker for Vitamin A status
retinol binding protein
marker for Vitamin A status
plasma zinc
plasma zinc
plasma zinc
plasma zinc

Full Information

First Posted
May 28, 2021
Last Updated
September 10, 2021
Sponsor
Swiss Federal Institute of Technology
Collaborators
Jomo Kenyatta University of Agriculture and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT04912661
Brief Title
Iron and Vaccine Response
Official Title
Iron and Vaccine-preventable Viral Disease - an Experimental Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 29, 2021 (Actual)
Primary Completion Date
September 9, 2021 (Actual)
Study Completion Date
September 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
Jomo Kenyatta University of Agriculture and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia, Vaccine Preventable Disease, Vaccine Response Impaired, Iron Deficiency Anemia Treatment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate iron treatment
Arm Type
Active Comparator
Arm Description
intravenous iron carboxymaltose before vaccination
Arm Title
No iron treatment
Arm Type
No Intervention
Arm Description
no intravenous iron carboxymaltose before vaccination
Intervention Type
Dietary Supplement
Intervention Name(s)
Ferinject
Intervention Description
intravenous iron carboxymaltose
Primary Outcome Measure Information:
Title
Antibody titers
Time Frame
at 35 days
Title
Antibody titers
Time Frame
at 63 days
Title
Seroconversion
Time Frame
at 35 days
Title
Seroconversion
Time Frame
at 63 days
Title
Antibody avidity Index
Description
percentage of antibodies that remain bound to beads
Time Frame
at 35 days
Title
Antibody avidity Index
Description
percentage of antibodies that remain bound to beads
Time Frame
at 63 days
Secondary Outcome Measure Information:
Title
antiviral immunoglobulin G response
Description
Immunoassay
Time Frame
day 0
Title
antiviral immunoglobulin G response
Description
Immunoassay
Time Frame
day 7
Title
antiviral immunoglobulin G response
Description
Immunoassay
Time Frame
day 35
Title
antiviral immunoglobulin G response
Description
Immunoassay
Time Frame
day 63
Title
immune cell populations
Description
number and type of immune cells
Time Frame
day 0
Title
immune cell populations
Description
number and type of immune cells
Time Frame
day 7
Title
immune cell populations
Description
number and type of immune cells
Time Frame
day 35
Title
immune cell populations
Description
number and type of immune cells
Time Frame
day 63
Title
Proteomics
Description
Proteins involved in immune response
Time Frame
day 0
Title
Proteomics
Description
Proteins involved in immune response
Time Frame
day 7
Title
Proteomics
Description
Proteins involved in immune response
Time Frame
day 35
Title
Proteomics
Description
Proteins involved in immune response
Time Frame
day 63
Title
Transcriptomics
Description
Genes involved in immune response
Time Frame
day 0
Title
Transcriptomics
Description
Genes involved in immune response
Time Frame
day 7
Title
Transcriptomics
Description
Genes involved in immune response
Time Frame
day 35
Title
Transcriptomics
Description
Genes involved in immune response
Time Frame
day 63
Title
Immune cell cytokine secretion
Description
ELISpot
Time Frame
day 7
Title
Immune cell cytokine secretion
Description
ELISpot
Time Frame
day 35
Title
Hemoglobin
Description
iron status parameter
Time Frame
day 0
Title
Hemoglobin
Description
iron status parameter
Time Frame
day 7
Title
Hemoglobin
Description
iron status parameter
Time Frame
day 35
Title
Hemoglobin
Description
iron status parameter
Time Frame
day 63
Title
Plasma Ferritin
Description
iron status parameter
Time Frame
day 0
Title
Plasma Ferritin
Description
iron status parameter
Time Frame
day 7
Title
Plasma Ferritin
Description
iron status parameter
Time Frame
day 35
Title
Plasma Ferritin
Description
iron status parameter
Time Frame
day 63
Title
Transferrin receptor
Description
iron status parameter
Time Frame
day 0
Title
Transferrin receptor
Description
iron status parameter
Time Frame
day 7
Title
Transferrin receptor
Description
iron status parameter
Time Frame
day 35
Title
Transferrin receptor
Description
iron status parameter
Time Frame
day 63
Title
Transferrin saturation
Description
iron status parameter
Time Frame
day 0
Title
Transferrin saturation
Description
iron status parameter
Time Frame
day 7
Title
Transferrin saturation
Description
iron status parameter
Time Frame
day 35
Title
Transferrin saturation
Description
iron status parameter
Time Frame
day 63
Title
C-reactive protein
Description
inflammation status parameter
Time Frame
day 0
Title
C-reactive protein
Description
inflammation status parameter
Time Frame
day 7
Title
C-reactive protein
Description
inflammation status parameter
Time Frame
day 35
Title
C-reactive protein
Description
inflammation status parameter
Time Frame
day 63
Title
Alpha-glycoprotein
Description
inflammation status parameter
Time Frame
day 0
Title
Alpha-glycoprotein
Description
inflammation status parameter
Time Frame
day 7
Title
Alpha-glycoprotein
Description
inflammation status parameter
Time Frame
day 28
Title
Alpha-glycoprotein
Description
inflammation status parameter
Time Frame
day 56
Title
retinol binding protein
Description
marker for Vitamin A status
Time Frame
day 0
Title
retinol binding protein
Description
marker for Vitamin A status
Time Frame
day 7
Title
retinol binding protein
Description
marker for Vitamin A status
Time Frame
day 35
Title
retinol binding protein
Description
marker for Vitamin A status
Time Frame
day 63
Title
plasma zinc
Time Frame
day 0
Title
plasma zinc
Time Frame
day 7
Title
plasma zinc
Time Frame
day 35
Title
plasma zinc
Time Frame
day 63

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Stoffel, PhD
Organizational Affiliation
ETH Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Msambweni County Referral Hospital
City
Msambweni
State/Province
Kwale
Country
Kenya

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Iron and Vaccine Response

We'll reach out to this number within 24 hrs