A longitudinal open-label study will include health professionals and patients with immune-mediated inflammatory diseases (IMID) who will receive the ChAdOx1 nCoV-19 vaccine (AZD1222), in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-thrid dose), in the vaccination campaign against SARS-CoV-2 to assess the safety, efficacy and duration of the short- and long-term humoral and cellular immune response after vaccination for COVID-19 and compare the vaccine response between individuals who have or have not had previous SARS-Cov 2 infection.
A longitudinal open-label study that will include individuals who will receive the ChAdOx1 nCoV-19 vaccine (AZD1222), in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-thrid dose), in the vaccination campaign against SARS-CoV-2 to assess the safety, efficacy and duration of the short- and long-term humoral and cellular immune response after vaccination for COVID- 19 and compare the vaccine response between individuals who have or have not had previous SARS-Cov 2 infection. Health professionals (HS) and patients with immune-mediated inflammatory diseases (IMID) who participate in vaccination campaigns at the Cassiano Antônio Mores da University Hospital will be included. Federal University of Espírito Santo (HUCAM-UFES). It is intended to include 200 health workers and 350 patients with IMID, totaling 550 participants. Participants who have had previous SARS-CoV-2 infection confirmed by RT-PCR or positive PRNT at baseline will be considered a group exposed to COVID-19 (CovPrev) and the group without previous infection will be considered a control group (Naive). The IMID group will include patients with Rheumatoid Arthritis (RA), Systemic Lupus Erythematosus (SLE), Spondyloarthritis (SA), Sjögren's Syndrome (SS), Psoriasis (Pso), Inflammatory Bowel Disease (IBD) and Vasculitis (VASC) who complete validated international classification criteria for each disease. The criteria for vaccination in the IMID group will be in accordance with the National Immunization Program of the Ministry of Health (PNI/MS). Adverse events will be recorded during the first, second and fourth week, and through weekly telephone contacts until D40. The evaluations and collection of biological samples will be carried out in 5 moments (D0, D14 and D28 after the first dose; D28 after the second dose; and D28 after thrid dose) to evaluate the efficacy and in 3 moments (D180, D360 and D540), to evaluate the duration of immunity. Neutralization tests by plaque reduction (PRNT) will be performed to detect neutralizing antibodies against COVID-19, determination of the profile of specific IgM, IgA and IgG, dosage of systemic soluble factors (chemokines, cytokines and growth factors), characterization of phenotypes of immunoregulation, immunosenescence, cell activation and exhaustion and antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The study hypothesis is that vaccine-induced production of neutralizing antibodies is more effective in individuals with previous natural SARS-Cov2 infection and less in immunosuppressed individuals.
ChAdOx1 nCoV-19 vaccine (AZD1222) in a standard 3-dose schedule with an interval of 12 weeks (first-second dose) and 24 weeks (second-third dose).
Federal University of Espirito Santo
Vitória, Espírito Santo, Brazil
RECRUITINGViral Neutralization Assay
Neutralizing antibody titers will be expressed by the ability of antibodies to neutralize up to 50% the number of plaques (PRNT50). Title \> 1:50 will be considered positive.
Time frame: 7 months
Viral Neutralization Assay
Neutralizing antibody titers will be expressed by the ability of antibodies to neutralize up to 50% the number of plaques (PRNT50). Title \> 1:50 will be considered positive.
Time frame: 24 months
IgM (Immunoglobulin M)
Determination of specific IgM profile. Results will be expressed in fluorescence intensity or pg/ml.
Time frame: 7 months
IgM (Immunoglobulin M)
Determination of specific IgM profile. Results will be expressed in fluorescence intensity or pg/ml.
Time frame: 24 months
IgG (Immunoglobulin G)
Determination of specific IgG profile. Results will be expressed in fluorescence intensity or pg/ml.
Time frame: 7 months
IgG (Immunoglobulin G)
Determination of specific IgG profile. Results will be expressed in fluorescence intensity or pg/ml.
Time frame: 24 months
IgA (Immunoglobulin G)
Determination of specific IgA profile. Results will be expressed in fluorescence intensity or pg/ml.
Time frame: 7 months
IgA (Immunoglobulin G)
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Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
550
Determination of specific IgA profile. Results will be expressed in fluorescence intensity or pg/ml.
Time frame: 24 months
systemic soluble factors
Dosage of soluble systemic factors (chemokines, cytokines and growth factors). Results will be expressed in pg/ml.
Time frame: 7 months
systemic soluble factors
Dosage of soluble systemic factors (chemokines, cytokines and growth factors). Results will be expressed in pg/ml.
Time frame: 24 months
Antigen-specific stimulation of peripheral blood mononuclear cells
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 1 month
Antigen-specific stimulation of peripheral blood mononuclear cells
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 6 months
Antigen-specific stimulation of peripheral blood mononuclear cells
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 12 months
Antigen-specific stimulation of peripheral blood mononuclear cells
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 18 months
Lymphocyte investigation
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 1 month
Lymphocyte investigation
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 6 months
Lymphocyte investigation
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 12 months
Lymphocyte investigation
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 18 months
Cytokine investigation
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 1 month
Cytokine investigation
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 6 months
Cytokine investigation
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 12 months
Cytokine investigation
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Time frame: 18 months
Adverse events
All adverse events will be followed up to establish severity and causal correlation. There will be surveillance of deaths and will be reported to the ethics committee.
Time frame: 1 month
Adverse events
All adverse events will be followed up to establish severity and causal correlation. There will be surveillance of deaths and will be reported to the ethics committee.
Time frame: 4 months
Adverse events
All adverse events will be followed up to establish severity and causal correlation. There will be surveillance of deaths and will be reported to the ethics committee.
Time frame: 6 months
severe cases of COVID-19
incidence of severe cases of COVID-19 over 20 months following treatment
Time frame: 24 months
deaths
Number of deaths with specific ICD for covid-19
Time frame: 24 months
hospital admissions
number of hospital admissions for covid-19
Time frame: 24 months
intensive care unit (ICU) admissions
number of intensive care unit (ICU) admissions for the treatment of SARS
Time frame: 24 months