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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04912661
Other study ID # DIVA I
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 29, 2021
Est. completion date September 9, 2021

Study information

Verified date September 2021
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 treatment improves their response.


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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date September 9, 2021
Est. primary completion date September 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility 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 Design


Intervention

Dietary Supplement:
Ferinject
intravenous iron carboxymaltose

Locations

Country Name City State
Kenya Msambweni County Referral Hospital Msambweni Kwale

Sponsors (2)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology Jomo Kenyatta University of Agriculture and Technology

Country where clinical trial is conducted

Kenya, 

Outcome

Type Measure Description Time frame Safety issue
Primary Antibody titers at 35 days
Primary Antibody titers at 63 days
Primary Seroconversion at 35 days
Primary Seroconversion at 63 days
Primary Antibody avidity Index percentage of antibodies that remain bound to beads at 35 days
Primary Antibody avidity Index percentage of antibodies that remain bound to beads at 63 days
Secondary antiviral immunoglobulin G response Immunoassay day 0
Secondary antiviral immunoglobulin G response Immunoassay day 7
Secondary antiviral immunoglobulin G response Immunoassay day 35
Secondary antiviral immunoglobulin G response Immunoassay day 63
Secondary immune cell populations number and type of immune cells day 0
Secondary immune cell populations number and type of immune cells day 7
Secondary immune cell populations number and type of immune cells day 35
Secondary immune cell populations number and type of immune cells day 63
Secondary Proteomics Proteins involved in immune response day 0
Secondary Proteomics Proteins involved in immune response day 7
Secondary Proteomics Proteins involved in immune response day 35
Secondary Proteomics Proteins involved in immune response day 63
Secondary Transcriptomics Genes involved in immune response day 0
Secondary Transcriptomics Genes involved in immune response day 7
Secondary Transcriptomics Genes involved in immune response day 35
Secondary Transcriptomics Genes involved in immune response day 63
Secondary Immune cell cytokine secretion ELISpot day 7
Secondary Immune cell cytokine secretion ELISpot day 35
Secondary Hemoglobin iron status parameter day 0
Secondary Hemoglobin iron status parameter day 7
Secondary Hemoglobin iron status parameter day 35
Secondary Hemoglobin iron status parameter day 63
Secondary Plasma Ferritin iron status parameter day 0
Secondary Plasma Ferritin iron status parameter day 7
Secondary Plasma Ferritin iron status parameter day 35
Secondary Plasma Ferritin iron status parameter day 63
Secondary Transferrin receptor iron status parameter day 0
Secondary Transferrin receptor iron status parameter day 7
Secondary Transferrin receptor iron status parameter day 35
Secondary Transferrin receptor iron status parameter day 63
Secondary Transferrin saturation iron status parameter day 0
Secondary Transferrin saturation iron status parameter day 7
Secondary Transferrin saturation iron status parameter day 35
Secondary Transferrin saturation iron status parameter day 63
Secondary C-reactive protein inflammation status parameter day 0
Secondary C-reactive protein inflammation status parameter day 7
Secondary C-reactive protein inflammation status parameter day 35
Secondary C-reactive protein inflammation status parameter day 63
Secondary Alpha-glycoprotein inflammation status parameter day 0
Secondary Alpha-glycoprotein inflammation status parameter day 7
Secondary Alpha-glycoprotein inflammation status parameter day 28
Secondary Alpha-glycoprotein inflammation status parameter day 56
Secondary retinol binding protein marker for Vitamin A status day 0
Secondary retinol binding protein marker for Vitamin A status day 7
Secondary retinol binding protein marker for Vitamin A status day 35
Secondary retinol binding protein marker for Vitamin A status day 63
Secondary plasma zinc day 0
Secondary plasma zinc day 7
Secondary plasma zinc day 35
Secondary plasma zinc day 63
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