Iron deficiency (ID) anemia (IDA) is a global public health problem, with the highest prevalence in Africa. Vaccines often underperform in low- and middle-income countries (LMIC), and undernutrition, including ID, likely plays a role. Recent studies have shown the importance of iron status in vaccine response. Intravenous iron given at time of vaccination improved response to yellow fever and COVID-19 vaccines in IDA Kenyan women. Whether oral iron treatment would have a similar beneficial effect on vaccine response is uncertain. Also, timing of oral iron treatment needs further investigation. The co-primary objectives of this study are to assess 1) whether IDA in Kenyan women impairs vaccine response, and whether oral iron treatment improves their response; 2) the timing of oral iron treatment to improve vaccine response (prior to vaccination vs at time of vaccination). We will conduct a double-blind randomized controlled trial in southern Kenya to assess the effects of iron supplementation on response to three single-shot vaccines: Johnson \& Johnson COVID- 19 (JJ COVID-19), the quadrivalent meningococcal vaccine (MenACWY) and the typhoid Vi polysaccharide vaccine (Typhim Vi). Women with IDA will be recruited and randomly assigned to three study groups: group 1 (pre- treatment) will receive 100 mg oral iron as ferrous sulfate (FeSO4) daily on days 1-56; group 2 (simultaneous treatment) will receive matching placebo daily on days 1-28, and 200 mg oral iron as FeSO4 daily on days 29-56; and group 3 (control) will receive matching placebo daily on days 1-56. Women in all groups will receive the JJ COVID-19 vaccine, the MenACWY and the Typhim Vi vaccine on day 28. Cellular immune response and serology will be measured at 28 days after vaccination in all groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
180
Iron supplements as 100 mg oral iron as FeSO4 given daily
MenACWY vaccination given on day 28 to all participants
Johnson \& Johnson COVID- 19 (JJ COVID-19) vaccination given on day 28 to all participants
matching placebo capsules given daily
Typhim Vi vaccination given on day 28 to all participants
Jomo Kenyatta University Of Agriculture And Technology
Nairobi, Kenya
RECRUITINGJJ COVID-19 vaccine response
Anti-spike (S1) IgG and anti-receptor-binding domain (RBD) IgG against SARS-COV-2
Time frame: Day 56
MenACWY vaccine response
Measurement of antibody response against serogroups A, C, W, and Y.
Time frame: Day 56
Typhoid vaccine response
Measurement of antibody response against Typhoid
Time frame: Day 56
Hemoglobin
iron status
Time frame: Day 1
Hemoglobin
iron status
Time frame: Day 28
Hemoglobin
iron status
Time frame: Day 56
Serum ferritin
iron status
Time frame: Day 1
Serum ferritin
iron status
Time frame: Day 28
Serum ferritin
iron status
Time frame: Day 56
soluble transferrin receptor
iron status
Time frame: Day 1
soluble transferrin receptor
iron status
Time frame: Day 28
soluble transferrin receptor
iron status
Time frame: Day 56
Plasma iron
iron status
Time frame: Day 1
Plasma iron
iron status
Time frame: Day 28
Plasma iron
iron status
Time frame: Day 56
Total iron binding capacity
iron status
Time frame: Day 1
Total iron binding capacity
iron status
Time frame: Day 28
Total iron binding capacity
iron status
Time frame: Day 56
Transferrin saturation
iron status
Time frame: Day 1
Transferrin saturation
iron status
Time frame: Day 28
Transferrin saturation
iron status
Time frame: Day 56
C- reactive protein
inflammation status
Time frame: Day 1
C- reactive protein
inflammation status
Time frame: Day 28
C- reactive protein
inflammation status
Time frame: Day 56
alpha- 1- glycoprotein
inflammation status
Time frame: Day 1
alpha- 1- glycoprotein
inflammation status
Time frame: Day 28
alpha- 1- glycoprotein
inflammation status
Time frame: Day 56
Retinol binding protein
Vitamin A status
Time frame: Day 1
Retinol binding protein
Vitamin A status
Time frame: Day 28
Retinol binding protein
Vitamin A status
Time frame: Day 56
Plasma zinc
Zinc status
Time frame: Day 1
COVID-19 specific T cell response
QuantiFERON SARS-CoV-2 whole blood assay - detection of IFN-gamma
Time frame: Day 28
COVID-19 specific T cell response
QuantiFERON SARS-CoV-2 whole blood assay - detection of IFN-gamma
Time frame: Day 56
COVID-19 specific T cell response
ELISpot assay on isolated peripheral blood mononuclear cells
Time frame: Day 28
COVID-19 specific T cell response
ELISpot assay on isolated peripheral blood mononuclear cells
Time frame: Day 56
Typhim Vi specific B-cell response
ELISpot assay on isolated peripheral blood mononuclear cells
Time frame: Day 28
Typhim Vi specific B-cell response
ELISpot assay on isolated peripheral blood mononuclear cells
Time frame: Day 56
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