Iron Deficiency AnemiaNCT04912661
Iron and Vaccine Response
A study testing Ferinject in people with Iron Deficiency Anemia and Vaccine Preventable Disease, run by Swiss Federal Institute of Technology at 1 site in Kenya.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia, Vaccine Preventable Disease, Vaccine Response Impaired
- What is being tested?
- Ferinject
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteKenya
- Study dates
- 29 May 2021to 9 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Iron Deficiency Anemia, Vaccine Preventable Disease, Vaccine Response Impaired, Iron Deficiency Anemia Treatment
- Being tested
- Ferinject
- Medical subject headings
- Anemia, Iron-Deficiency, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerinjectDietary supplement
intravenous iron carboxymaltose
| Study group | Role | What they receive |
|---|---|---|
| Immediate iron treatment | Active comparator | intravenous iron carboxymaltose before vaccination Receives: Dietary Supplement: Ferinject |
| No iron treatment | No intervention | no intravenous iron carboxymaltose before vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titers
Measured: at 35 days
Antibody titers
Measured: at 63 days
Seroconversion
Measured: at 35 days
Seroconversion
Measured: at 63 days
Antibody avidity Index
percentage of antibodies that remain bound to beads
Measured: at 35 days
Antibody avidity Index
percentage of antibodies that remain bound to beads
Measured: at 63 days
Secondary outcomes (50)
antiviral immunoglobulin G response
Immunoassay
Measured: day 0
antiviral immunoglobulin G response
Immunoassay
Measured: day 7
antiviral immunoglobulin G response
Immunoassay
Measured: day 35
antiviral immunoglobulin G response
Immunoassay
Measured: day 63
immune cell populations
number and type of immune cells
Measured: day 0
immune cell populations
number and type of immune cells
Measured: day 7
immune cell populations
number and type of immune cells
Measured: day 35
immune cell populations
number and type of immune cells
Measured: day 63
Proteomics
Proteins involved in immune response
Measured: day 0
Proteomics
Proteins involved in immune response
Measured: day 7
Proteomics
Proteins involved in immune response
Measured: day 35
Proteomics
Proteins involved in immune response
Measured: day 63
Transcriptomics
Genes involved in immune response
Measured: day 0
Transcriptomics
Genes involved in immune response
Measured: day 7
Transcriptomics
Genes involved in immune response
Measured: day 35
Transcriptomics
Genes involved in immune response
Measured: day 63
Immune cell cytokine secretion
ELISpot
Measured: day 7
Immune cell cytokine secretion
ELISpot
Measured: day 35
Hemoglobin
iron status parameter
Measured: day 0
Hemoglobin
iron status parameter
Measured: day 7
Hemoglobin
iron status parameter
Measured: day 35
Hemoglobin
iron status parameter
Measured: day 63
Plasma Ferritin
iron status parameter
Measured: day 0
Plasma Ferritin
iron status parameter
Measured: day 7
Plasma Ferritin
iron status parameter
Measured: day 35
Plasma Ferritin
iron status parameter
Measured: day 63
Transferrin receptor
iron status parameter
Measured: day 0
Transferrin receptor
iron status parameter
Measured: day 7
Transferrin receptor
iron status parameter
Measured: day 35
Transferrin receptor
iron status parameter
Measured: day 63
Transferrin saturation
iron status parameter
Measured: day 0
Transferrin saturation
iron status parameter
Measured: day 7
Transferrin saturation
iron status parameter
Measured: day 35
Transferrin saturation
iron status parameter
Measured: day 63
C-reactive protein
inflammation status parameter
Measured: day 0
C-reactive protein
inflammation status parameter
Measured: day 7
C-reactive protein
inflammation status parameter
Measured: day 35
C-reactive protein
inflammation status parameter
Measured: day 63
Alpha-glycoprotein
inflammation status parameter
Measured: day 0
Alpha-glycoprotein
inflammation status parameter
Measured: day 7
Alpha-glycoprotein
inflammation status parameter
Measured: day 28
Alpha-glycoprotein
inflammation status parameter
Measured: day 56
retinol binding protein
marker for Vitamin A status
Measured: day 0
retinol binding protein
marker for Vitamin A status
Measured: day 7
retinol binding protein
marker for Vitamin A status
Measured: day 35
retinol binding protein
marker for Vitamin A status
Measured: day 63
plasma zinc
Measured: day 0
plasma zinc
Measured: day 7
plasma zinc
Measured: day 35
plasma zinc
Measured: day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start29 May 2021
- Primary completion9 Sep 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology
- Responsible party
- Principal investigator, Nicole Stoffel, Swiss Federal Institute of Technology
- Investigators
- Nicole Stoffel, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04912661
- Sponsor's protocol ID
- DIVA I
- Status last verified
- Sep 2021
- First submitted
- 28 May 2021
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron and Vaccine-preventable Viral Disease - an Experimental Study
- ClinicalTrials.gov ID
- NCT04912661
- Acronym / sponsor ID
- DIVA I
- Conditions
- Iron Deficiency Anemia, Vaccine Preventable Disease, Vaccine Response Impaired, Iron Deficiency Anemia Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Jomo Kenyatta University of Agriculture and Technology
- Study start
- 29 May 2021 (actual)
- Primary completion
- 9 Sep 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate iron treatment | Active comparator | Dietary Supplement: Ferinjectintravenous iron carboxymaltose before vaccination |
| No iron treatment | No intervention | –no intravenous iron carboxymaltose before vaccination |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 18-55 years old
- Zinc protoporphyrin > or equal 40 mmol/mol heme
- hemoglobin < or equal 109 g/L
- no malaria
- no known HIV infection
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferinjectintravenous iron carboxymaltose | Dietary supplement | Immediate iron treatment |
Primary outcome
Antibody titers
Time frame: at 35 days
Antibody titers
Time frame: at 63 days
Seroconversion
Time frame: at 35 days
Seroconversion
Time frame: at 63 days
Antibody avidity Index
Time frame: at 35 days
percentage of antibodies that remain bound to beads
Antibody avidity Index
Time frame: at 63 days
percentage of antibodies that remain bound to beads
50 secondary outcomes
antiviral immunoglobulin G response
Time frame: day 0
antiviral immunoglobulin G response
Time frame: day 7
antiviral immunoglobulin G response
Time frame: day 35
antiviral immunoglobulin G response
Time frame: day 63
immune cell populations
Time frame: day 0
immune cell populations
Time frame: day 7
immune cell populations
Time frame: day 35
immune cell populations
Time frame: day 63
Proteomics
Time frame: day 0
Proteomics
Time frame: day 7
Proteomics
Time frame: day 35
Proteomics
Time frame: day 63
Transcriptomics
Time frame: day 0
Transcriptomics
Time frame: day 7
Transcriptomics
Time frame: day 35
Transcriptomics
Time frame: day 63
Immune cell cytokine secretion
Time frame: day 7
Immune cell cytokine secretion
Time frame: day 35
Hemoglobin
Time frame: day 0
Hemoglobin
Time frame: day 7
Hemoglobin
Time frame: day 35
Hemoglobin
Time frame: day 63
Plasma Ferritin
Time frame: day 0
Plasma Ferritin
Time frame: day 7
Plasma Ferritin
Time frame: day 35
Plasma Ferritin
Time frame: day 63
Transferrin receptor
Time frame: day 0
Transferrin receptor
Time frame: day 7
Transferrin receptor
Time frame: day 35
Transferrin receptor
Time frame: day 63
Transferrin saturation
Time frame: day 0
Transferrin saturation
Time frame: day 7
Transferrin saturation
Time frame: day 35
Transferrin saturation
Time frame: day 63
C-reactive protein
Time frame: day 0
C-reactive protein
Time frame: day 7
C-reactive protein
Time frame: day 35
C-reactive protein
Time frame: day 63
Alpha-glycoprotein
Time frame: day 0
Alpha-glycoprotein
Time frame: day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Stoffel, PhD principal investigator
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferinject in people with Iron Deficiency Anemia and Vaccine Preventable Disease, run by Swiss Federal Institute of Technology at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody titers (time frame: at 35 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2021.