Iron and COVID-19 Vaccine Response

Iron Deficiency Anemia Clinical Trial

Official title:

Iron and Vaccine-preventable Viral Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04915820
• Other study ID #: DIVA II
• Status: Completed
• Phase: N/A
• Start date: May 29, 2021
• Est. completion date: September 9, 2021

Study information

• Verified date: September 2021
• Source: Jomo Kenyatta University of Agriculture and Technology
• Contact: n/a
• Is FDA regulated: No
• 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 the COVID-19 vaccine, 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 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.

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:

-

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• COVID-19 Vaccine
• Deficiency Diseases
• Iron Deficiency Anemia
• Iron Deficiency Anemia Treatment
• Vaccine Response Impaired

Intervention

Dietary Supplement:
• Ferinject
intravenous iron carboxymaltose

Locations

Country	Name	City	State
Kenya	Msambweni County Referral Hospital	Msambweni	Kwale

Sponsors (1)

Lead Sponsor	Collaborator
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		day 35
Primary	Antibody titers		day 63
Primary	Seroconversion		day 35
Primary	Seroconversion		day 63
Primary	Antibody avidity index	percentage of antibodies that remain bound to beads	day 35
Primary	Antibody avidity index	percentage of antibodies that remain bound to beads	day 63
Secondary	antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response	immunoassay	day 0
Secondary	antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response	immunoassay	day 7
Secondary	antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response	immunoassay	day 35
Secondary	antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response 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	day63
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 35
Secondary	Alpha-glycoprotein	inflammation status parameter	day 63
Secondary	retinol binding protein	vitamin A status marker	day 0
Secondary	retinol binding protein	vitamin A status marker	day 7
Secondary	retinol binding protein	vitamin A status marker	day 35
Secondary	retinol binding protein	vitamin A status marker	day 63
Secondary	plasma zinc		day 35