Effect of SARSCoV2 (COVID-19) Vaccination in Type 1 Diabetes (CoVaxT1D)

NCT ID: NCT04905823

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2022-06-30

Brief Summary

Given the high risk of severe SARS-CoV-2 infection, patients with T1D and T2D should represent a priority group to receive the SARS-CoV-2 vaccine. There are currently no studies on diabetic population response to mRNA COVID-19 vaccines. Therefore, in this observational cohort study, investigators will retrospectively analyze the safety and immunogenicity of the mRNA vaccines in eliciting both the humoral and cellular immune response in a subset of patients with T1D who already underwent blood sampling for measuring humoral response against SARSCoV2 for healthcare purposes and based on the clinical practice guidelines. Results will be compared with those obtained in non-diabetic individuals or in patients with non-autoimmune diabetes (T2D).

Detailed Description

Since the beginning of the COVID-19 pandemic in March 2020, more than 160 million people have suffered from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and more than 3 million deaths occurred. Currently, two vaccines using messenger RNA (mRNA) technology and lipid nanoparticle (LNP) delivery systems have been approved for emergency use by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA): mRNA-1273, Moderna, and BNT162b2, Pfizer. In phase-3 clinical trials, two injections of these vaccines, spaced 21 and 28 days apart, showed efficacy higher than 90% in preventing symptomatic infections. The reported humoral immunity response with the mRNA vaccines was similar to that elicited by convalescent serum obtained from patients who recovered from Covid-19 infection. However, the T-cell mediated reaction to these vaccines remains to be fully elucidated. Diabetic patients are at higher risk of developing severe SARS-CoV-2 infection. In a large observational cohort study, the overall risks of fatal or critical care unit-treated COVID-19 were significantly elevated for patients with diabetes compared with the general population. While patients with Type 2 diabetes (T2D) are usually older and with a higher comorbidity index, the altered immune functions seem to play a major role in patients with Type 1 Diabetes (T1D). Altough an impaired immune response to vaccination was hypothesized in diabetic patients, no evidence has been provided. Given the high risk of severe SARS-CoV-2 infection, patients with T1D and T2D should represent a priority group to receive the COVID-19 vaccine. There are currently no studies on diabetic population response to mRNA COVID-19 vaccines. Therefore, in this observational cohort study, investigators will retrospectively analyze the safety and immunogenicity of the mRNA vaccines in eliciting both the humoral and cellular immune response in a subset of patients with T1D, T2D and in non-diabetic individuals who already underwent blood sampling for measuring humoral response against SARSCoV2 for healthcare purposes and based on the clinical practice guidelines.

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Type 1 diabetes patients

Patients with type 1 diabetes

blood test

Intervention Type: DIAGNOSTIC_TEST

assessment of humoral, immune cell response and glycemia

Non-diabetic subjects

Subjects in whom diabetes has not been diagnosed

blood test

Intervention Type: DIAGNOSTIC_TEST

assessment of humoral, immune cell response and glycemia

Type 2 diabetes patients

Patients with type 2 diabetes

blood test

Intervention Type: DIAGNOSTIC_TEST

assessment of humoral, immune cell response and glycemia

Interventions

blood test

assessment of humoral, immune cell response and glycemia

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• age >16
• History of type 1 diabetes
• previous blood test in search for SARSCoV2 antibodies
• willingness to provide informed consent

• age >16
• No previous history of diabetes
• previous blood test in search for SARSCoV2 antibodies
• willingness to provide informed consent

• age >16
• History of type 2 diabetes but no evidence of autoantibodies
• previous blood test in search for SARSCoV2 antibodies
• willingness to provide informed consent

Exclusion Criteria

• age <16 years
• Systemic infections
• Diabetic ketoacidosis in the past 6 weeks
• COVID-19 diagnosis in the previous 6 months

• age <16 years
• Systemic infections
• COVID-19 diagnosis in the previous 6 months

• age <16 years
• Systemic infections
• COVID-19 diagnosis in the previous 6 months

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ASST Fatebenefratelli Sacco

OTHER

Sponsor Role: collaborator

Paolo Fiorina, MD

OTHER

Sponsor Role: lead

Responsible Party

Paolo Fiorina, MD

Professor of Endocrinology, Chief of Endocrinology Division

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

ASST FBF-Sacco P.O. Sacco

Milan, MI, Italy

Countries

Italy

References

D'Addio F, Sabiu G, Usuelli V, Assi E, Abdelsalam A, Maestroni A, Seelam AJ, Ben Nasr M, Loretelli C, Mileto D, Rossi G, Pastore I, Montefusco L, Morpurgo PS, Plebani L, Rossi A, Chebat E, Bolla AM, Lunati ME, Mameli C, Macedoni M, Antinori S, Rusconi S, Gallieni M, Berra C, Folli F, Galli M, Gismondo MR, Zuccotti G, Fiorina P. Immunogenicity and Safety of SARS-CoV-2 mRNA Vaccines in a Cohort of Patients With Type 1 Diabetes. Diabetes. 2022 Aug 1;71(8):1800-1806. doi: 10.2337/db22-0053.

Reference Type: DERIVED

PMID: 35551366 (View on PubMed)

Other Identifiers

CoVaxT1D

Identifier Type: -

Identifier Source: org_study_id