A longitudinal open-label study will include health professionals and patients withimmune-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 toassess the safety, efficacy and duration of the short- and long-term humoral and cellularimmune response after vaccination for COVID-19 and compare the vaccine response betweenindividuals 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.
Biological: ChAdOx1 nCoV-19 vaccine (AZD1222)
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).
Inclusion Criteria:
- Age 18 years or older
Exclusion Criteria:
- Pregnant women;
- History of severe adverse reaction to any previously administered vaccine;
- Having received another vaccine in the last 30 days.
- The criteria for vaccination in the immune-mediated inflammatory diseases
(IMID) group will be in accordance with the Ministry of Health's National
Immunization Program (PNI/MS).
Federal University of Espirito Santo
Vitoria, Espirito Santo, Brazil
Investigator: Valéria Valim, PhD
Contact: 2733157899
val.valim@gmail.com
Valéria Valim, PhD
+5527999874665
val.valim@gmail.com
Valéria Valim, PhD, Principal Investigator
Federal University of Espirito Santo