Clinical trial NCT04915820: Iron and COVID-19 Vaccine Response
Official title: Iron and Vaccine-preventable Viral Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency Anemia
Vaccine Response Impaired
COVID-19 Vaccine
Iron Deficiency Anemia Treatment
Lead sponsor: Jomo Kenyatta University of Agriculture and Technology
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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:

-

Primary outcomes:
measure: Antibody titers
timeFrame: day 35
measure: Antibody titers
timeFrame: day 63
measure: Seroconversion
timeFrame: day 35
measure: Seroconversion
timeFrame: day 63
measure: Antibody avidity index
timeFrame: day 35
measure: Antibody avidity index
timeFrame: day 63
Secondary outcomes:
measure: antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response
timeFrame: day 0
measure: antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response
timeFrame: day 7
measure: antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response
timeFrame: day 35
measure: antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response antiviral immunoglobulin G response
timeFrame: day 63
measure: immune cell populations
timeFrame: day 0
measure: immune cell populations
timeFrame: day 7
measure: immune cell populations
timeFrame: day 35
measure: immune cell populations
timeFrame: day63
measure: Proteomics
timeFrame: day 0
measure: Proteomics
timeFrame: day 7
measure: Proteomics
timeFrame: day 35
measure: Proteomics
timeFrame: day 63
measure: Transcriptomics
timeFrame: day 0
measure: Transcriptomics
timeFrame: day 7
measure: Transcriptomics
timeFrame: day 35
measure: Transcriptomics
timeFrame: day 63
measure: Immune cell cytokine secretion
timeFrame: day 7
measure: Immune cell cytokine secretion
timeFrame: day 35
measure: Hemoglobin
timeFrame: day 0
measure: Hemoglobin
timeFrame: day 7
measure: Hemoglobin
timeFrame: day 35
measure: Hemoglobin
timeFrame: day 63
measure: Plasma ferritin
timeFrame: day 0
measure: Plasma ferritin
timeFrame: day 7
measure: Plasma ferritin
timeFrame: day 35
measure: Plasma ferritin
timeFrame: day 63
measure: Transferrin receptor
timeFrame: day 0
measure: Transferrin receptor
timeFrame: day 7
measure: Transferrin receptor
timeFrame: day 35
measure: Transferrin receptor
timeFrame: day 63
measure: Transferrin saturation
timeFrame: day 0
measure: Transferrin saturation
timeFrame: day 7
measure: Transferrin saturation
timeFrame: day 35
measure: Transferrin saturation
timeFrame: day 63
measure: C-reactive protein
timeFrame: day 0
measure: C-reactive protein
timeFrame: day 7
measure: C-reactive protein
timeFrame: day 35
measure: C-reactive protein
timeFrame: day 63
measure: Alpha-glycoprotein
timeFrame: day 0
measure: Alpha-glycoprotein
timeFrame: day 7
measure: Alpha-glycoprotein
timeFrame: day 35
measure: Alpha-glycoprotein
timeFrame: day 63
measure: retinol binding protein
timeFrame: day 0
measure: retinol binding protein
timeFrame: day 7
measure: retinol binding protein
timeFrame: day 35
measure: retinol binding protein
timeFrame: day 63
measure: plasma zinc
timeFrame: day 35
Other outcomes:
Locations:
city: Msambweni
country: Kenya
facility: Msambweni County Referral Hospital
state: Kwale
Study officials:
affiliation: JKUAT Nairobi
name: Simon Karanja, PhD
role: PRINCIPAL_INVESTIGATOR
References: