Iron and Vaccine Response

September 10, 2021 updated by: Nicole Stoffel, Swiss Federal Institute of Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
121

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antibody titers
Time Frame: at 35 days
at 35 days
Antibody titers
Time Frame: at 63 days
at 63 days
Seroconversion
Time Frame: at 35 days
at 35 days
Seroconversion
Time Frame: at 63 days
at 63 days
Antibody avidity Index
Time Frame: at 35 days
percentage of antibodies that remain bound to beads
at 35 days
Antibody avidity Index
Time Frame: at 63 days
percentage of antibodies that remain bound to beads
at 63 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
immune cell populations
Time Frame: day 0
number and type of immune cells
day 0
immune cell populations
Time Frame: day 7
number and type of immune cells
day 7
immune cell populations
Time Frame: day 35
number and type of immune cells
day 35
Proteomics
Time Frame: day 0
Proteins involved in immune response
day 0
Proteomics
Time Frame: day 7
Proteins involved in immune response
day 7
Proteomics
Time Frame: day 35
Proteins involved in immune response
day 35
Proteomics
Time Frame: day 63
Proteins involved in immune response
day 63
Transcriptomics
Time Frame: day 0
Genes involved in immune response
day 0
Transcriptomics
Time Frame: day 7
Genes involved in immune response
day 7
Transcriptomics
Time Frame: day 35
Genes involved in immune response
day 35
Transcriptomics
Time Frame: day 63
Genes involved in immune response
day 63
Immune cell cytokine secretion
Time Frame: day 7
ELISpot
day 7
Immune cell cytokine secretion
Time Frame: day 35
ELISpot
day 35
Hemoglobin
Time Frame: day 0
iron status parameter
day 0
Hemoglobin
Time Frame: day 7
iron status parameter
day 7
Hemoglobin
Time Frame: day 35
iron status parameter
day 35
Hemoglobin
Time Frame: day 63
iron status parameter
day 63
Transferrin receptor
Time Frame: day 0
iron status parameter
day 0
Transferrin receptor
Time Frame: day 7
iron status parameter
day 7
Transferrin receptor
Time Frame: day 35
iron status parameter
day 35
Transferrin receptor
Time Frame: day 63
iron status parameter
day 63
Transferrin saturation
Time Frame: day 0
iron status parameter
day 0
Transferrin saturation
Time Frame: day 7
iron status parameter
day 7
Transferrin saturation
Time Frame: day 35
iron status parameter
day 35
Transferrin saturation
Time Frame: day 63
iron status parameter
day 63
C-reactive protein
Time Frame: day 0
inflammation status parameter
day 0
C-reactive protein
Time Frame: day 7
inflammation status parameter
day 7
C-reactive protein
Time Frame: day 35
inflammation status parameter
day 35
C-reactive protein
Time Frame: day 63
inflammation status parameter
day 63
Alpha-glycoprotein
Time Frame: day 0
inflammation status parameter
day 0
Alpha-glycoprotein
Time Frame: day 7
inflammation status parameter
day 7
plasma zinc
Time Frame: day 35
day 35
antiviral immunoglobulin G response
Time Frame: day 0
Immunoassay
day 0
antiviral immunoglobulin G response
Time Frame: day 7
Immunoassay
day 7
antiviral immunoglobulin G response
Time Frame: day 35
Immunoassay
day 35
antiviral immunoglobulin G response
Time Frame: day 63
Immunoassay
day 63
immune cell populations
Time Frame: day 63
number and type of immune cells
day 63
Plasma Ferritin
Time Frame: day 0
iron status parameter
day 0
Plasma Ferritin
Time Frame: day 7
iron status parameter
day 7
Plasma Ferritin
Time Frame: day 35
iron status parameter
day 35
Plasma Ferritin
Time Frame: day 63
iron status parameter
day 63
Alpha-glycoprotein
Time Frame: day 28
inflammation status parameter
day 28
Alpha-glycoprotein
Time Frame: day 56
inflammation status parameter
day 56
retinol binding protein
Time Frame: day 0
marker for Vitamin A status
day 0
retinol binding protein
Time Frame: day 7
marker for Vitamin A status
day 7
retinol binding protein
Time Frame: day 35
marker for Vitamin A status
day 35
retinol binding protein
Time Frame: day 63
marker for Vitamin A status
day 63
plasma zinc
Time Frame: day 0
day 0
plasma zinc
Time Frame: day 7
day 7
plasma zinc
Time Frame: day 63
day 63

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Swiss Federal Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jomo Kenyatta University of Agriculture and Technology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicole Stoffel, PhD, ETH Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 9, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 9, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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