Back to resultsIron and COVID-19 Vaccine Response
Primary Purpose
Iron Deficiency Anemia, Vaccine Response Impaired, COVID-19 Vaccine
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Ferinject
Sponsored by
About this trial
This is an interventional basic science trial for Iron Deficiency Anemia
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:
-
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 antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response
immunoassay
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response
immunoassay
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response
immunoassay
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response 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
vitamin A status marker
retinol binding protein
vitamin A status marker
retinol binding protein
vitamin A status marker
retinol binding protein
vitamin A status marker
plasma zinc
Full Information
NCT ID
NCT04915820
First Posted
May 28, 2021
Last Updated
September 10, 2021
Sponsor
Jomo Kenyatta University of Agriculture and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04915820
Brief Title
Iron and COVID-19 Vaccine Response
Official Title
Iron and Vaccine-preventable Viral Disease
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
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 the COVID-19 vaccine, 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia, Vaccine Response Impaired, COVID-19 Vaccine, 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
day 35
Title
Antibody titers
Time Frame
day 63
Title
Seroconversion
Time Frame
day 35
Title
Seroconversion
Time Frame
day 63
Title
Antibody avidity index
Description
percentage of antibodies that remain bound to beads
Time Frame
day 35
Title
Antibody avidity index
Description
percentage of antibodies that remain bound to beads
Time Frame
day 63
Secondary Outcome Measure Information:
Title
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response
Description
immunoassay
Time Frame
day 0
Title
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response
Description
immunoassay
Time Frame
day 7
Title
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response
Description
immunoassay
Time Frame
day 35
Title
antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response 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
day63
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 35
Title
Alpha-glycoprotein
Description
inflammation status parameter
Time Frame
day 63
Title
retinol binding protein
Description
vitamin A status marker
Time Frame
day 0
Title
retinol binding protein
Description
vitamin A status marker
Time Frame
day 7
Title
retinol binding protein
Description
vitamin A status marker
Time Frame
day 35
Title
retinol binding protein
Description
vitamin A status marker
Time Frame
day 63
Title
plasma zinc
Time Frame
day 35
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
Simon Karanja, PhD
Organizational Affiliation
JKUAT Nairobi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Msambweni County Referral Hospital
City
Msambweni
State/Province
Kwale
Country
Kenya
12. IPD Sharing Statement
Learn more about this trial
Iron and COVID-19 Vaccine Response
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