Immune response to COVID-19 Vaccination in people with Diabetes Mellitus

Immune response to COVID-19 Vaccination in people with Diabetes Mellitus - COVAC-DM study - COVAC-DM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001459-15-AT

Enrollment

160

Registered

2021-03-22

Start date

2021-04-26

Completion date

Unknown

Last updated

2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Interventions

Trade Name: COVID-19 Vaccine AstraZeneca Product Name: COVID-19 Vaccine AstraZeneca Product Code: EMEA/H/C/005675 Pharmaceutical Form: Injection INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recom

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for Diabetes Mellitus Cohort -Age between 18 and 80 years, both inclusive -Planned COVID-19 vaccination Cohort I (Diabetes mellitus Type 1, well controlled) Glycated haemoglobin levels HbA1c =7.5 % Cohort II (Diabetes mellitus Type 1, uncontrolled) Glycated haemoglobin levels HbA1c >7.5 % Cohort III (Diabetes mellitus Type 2, well controlled) Glycated haemoglobin levels HbA1c =7.5 % Cohort IV (Diabetes mellitus Type 2, uncontrolled) Glycated haemoglobin levels HbA1c >7.5 % Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 110 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Exlcusion criteria for Diabetes Mellitus Cohort -Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma -Pregnancy or intention of becoming pregnant; breastfeeding -Immunosuppressive therapy -Acute or chronic inflammatory disorder -Alcohol abuse (more than 15 drinks / week) -Any contraindication to the vaccine planned to receive as listed in the product characteristics -Previous COVID-19 vaccine or episode of COVID-19

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to investigate the short and mid-term humoral immune response to COVID-19 vaccines as assessed by anti-spike protein antibodies in people with diabetes as compared to healthy controls.;Secondary Objective: Secondary objective -to investigate the difference in the short and mid-term humoral immune response to COVID-19 vaccines in people with type 1 and type 2 diabetes, either with good or unsatisfactory glycaemic control. -to investigate glycaemic excursions and required changes to antihyperglycaemic doses or treatment regimens following COVID-19 vaccination in people with diabetes. -to investigate changes to the coagulatory system in people with diabetes as compared to healthy controls following COVID-19 vaccination. -to investigate the safety profile of COVID-19 vaccines in people with diabetes. ;Primary end point(s): Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls.;Timepoint(s) of evaluation of this end point: Baseline and Visit 3 (2-3 weeks after second vaccination)	—

Measure

Time frame

Main Objective: The primary objective is to investigate the short and mid-term humoral immune response to COVID-19 vaccines as assessed by anti-spike protein antibodies in people with diabetes as compared to healthy controls.;Secondary Objective: Secondary objective -to investigate the difference in the short and mid-term humoral immune response to COVID-19 vaccines in people with type 1 and type 2 diabetes, either with good or unsatisfactory glycaemic control. -to investigate glycaemic excursions and required changes to antihyperglycaemic doses or treatment regimens following COVID-19 vaccination in people with diabetes. -to investigate changes to the coagulatory system in people with diabetes as compared to healthy controls following COVID-19 vaccination. -to investigate the safety profile of COVID-19 vaccines in people with diabetes. ;Primary end point(s): Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls.;Timepoint(s) of evaluation of this end point: Baseline and Visit 3 (2-3 weeks after second vaccination)

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Secondary

Measure	Time frame
Secondary end point(s): -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 2 (1-2 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls. -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 4 (12 months) between people with diabetes (all 4 groups pooled) and healthy controls. -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) the 4 groups of people with diabetes -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 4 (12 months) the 4 groups of people with diabetes -Differences in the immune phenotype (B cell and T cell subsets) between the 5 cohorts before the vaccination Immune phenotype predictors (B cell subsets, T cell subsets) at baseline for the anti-SARS-CoV-2 spike protein humoral immune response at Visit 3 based on immune-phenotyping patterns at baseline (B cell subsets, T cell subsets) -Glycaemic profiles (time in range, time below range and time above range), number of hypoglycaemia (15 min via isCGM/CGM) and hyperglycaemia (>180 mg/dL and >250 mg/dL), glycaemic variability (%CV, SD), post-prandial glucose excursion, and therapy (total daily insulin dose [basal rate/basal insulin and bolus insulin], carbohydrate to insulin ratio, number and amount of insulin corrections) the week following the vaccination as compared to the week before the first vaccination -Difference in the change of coagulation parameters from baseline to Visit 2 in people with diabetes and healthy controls. -Adverse events following the vaccinations;Timepoint(s) of evaluation of this end point: Baseline, Visit 2, Visit 3 and Visit 4	—

Measure

Time frame

Secondary end point(s): -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 2 (1-2 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls. -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 4 (12 months) between people with diabetes (all 4 groups pooled) and healthy controls. -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) the 4 groups of people with diabetes -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 4 (12 months) the 4 groups of people with diabetes -Differences in the immune phenotype (B cell and T cell subsets) between the 5 cohorts before the vaccination Immune phenotype predictors (B cell subsets, T cell subsets) at baseline for the anti-SARS-CoV-2 spike protein humoral immune response at Visit 3 based on immune-phenotyping patterns at baseline (B cell subsets, T cell subsets) -Glycaemic profiles (time in range, time below range and time above range), number of hypoglycaemia (15 min via isCGM/CGM) and hyperglycaemia (>180 mg/dL and >250 mg/dL), glycaemic variability (%CV, SD), post-prandial glucose excursion, and therapy (total daily insulin dose [basal rate/basal insulin and bolus insulin], carbohydrate to insulin ratio, number and amount of insulin corrections) the week following the vaccination as compared to the week before the first vaccination -Difference in the change of coagulation parameters from baseline to Visit 2 in people with diabetes and healthy controls. -Adverse events following the vaccinations;Timepoint(s) of evaluation of this end point: Baseline, Visit 2, Visit 3 and Visit 4

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Countries

Austria

Contacts

Public ContactTrial Manager

Medical University of Graz

norbert.tripolt@medunigraz.at43316385 78038

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026