COVID-19 VACCINE SAFETY AND EFFECTIVENESS

Sponsor

Federal University of Espirito Santo (Other)

Overall Status

Recruiting

CT.gov ID

NCT05133609

Collaborator

Instituto René Rachou/Fiocruz (Other)

550

Enrollment

Location

Arms

35.4

Anticipated Duration (Months)

15.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Infection	Biological: ChAdOx1 nCoV-19 vaccine (AZD1222)	Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

550 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

COVID-19 VACCINE SAFETY AND EFFECTIVENESS

Actual Study Start Date :

Jan 15, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Health professionals who will receive vaccine in the vaccination campaign against SARS-CoV-2.	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).
Experimental: Group 2 Patients with immune-mediated inflammatory diseases who will receive vaccine in the vaccination campaign against SARS-CoV-2.	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).

Arm

Intervention/Treatment

Experimental: Group 1

Health professionals who will receive vaccine in the vaccination campaign against SARS-CoV-2.

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).

Experimental: Group 2

Patients with immune-mediated inflammatory diseases who will receive vaccine in the vaccination campaign against SARS-CoV-2.

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).

Outcome Measures

Primary Outcome Measures

Viral Neutralization Assay [7 months]
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.
Viral Neutralization Assay [24 months]
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.

Secondary Outcome Measures

IgM (Immunoglobulin M) [7 months]
Determination of specific IgM profile. Results will be expressed in fluorescence intensity or pg/ml.
IgM (Immunoglobulin M) [24 months]
Determination of specific IgM profile. Results will be expressed in fluorescence intensity or pg/ml.
IgG (Immunoglobulin G) [7 months]
Determination of specific IgG profile. Results will be expressed in fluorescence intensity or pg/ml.
IgG (Immunoglobulin G) [24 months]
Determination of specific IgG profile. Results will be expressed in fluorescence intensity or pg/ml.
IgA (Immunoglobulin G) [7 months]
Determination of specific IgA profile. Results will be expressed in fluorescence intensity or pg/ml.
IgA (Immunoglobulin G) [24 months]
Determination of specific IgA profile. Results will be expressed in fluorescence intensity or pg/ml.
systemic soluble factors [7 months]
Dosage of soluble systemic factors (chemokines, cytokines and growth factors). Results will be expressed in pg/ml.
systemic soluble factors [24 months]
Dosage of soluble systemic factors (chemokines, cytokines and growth factors). Results will be expressed in pg/ml.
Antigen-specific stimulation of peripheral blood mononuclear cells [1 month]
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Antigen-specific stimulation of peripheral blood mononuclear cells [6 months]
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Antigen-specific stimulation of peripheral blood mononuclear cells [12 months]
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Antigen-specific stimulation of peripheral blood mononuclear cells [18 months]
Antigen-specific stimulation of peripheral blood mononuclear cells in vitro. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Lymphocyte investigation [1 month]
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Lymphocyte investigation [6 months]
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Lymphocyte investigation [12 months]
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Lymphocyte investigation [18 months]
Investigation of memory T and B lymphocytes. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Cytokine investigation [1 month]
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Cytokine investigation [6 months]
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Cytokine investigation [12 months]
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Cytokine investigation [18 months]
Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.
Adverse events [1 month]
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.
Adverse events [4 months]
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.
Adverse events [6 months]
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.
severe cases of COVID-19 [24 months]
incidence of severe cases of COVID-19 over 20 months following treatment
deaths [24 months]
Number of deaths with specific ICD for covid-19
hospital admissions [24 months]
number of hospital admissions for covid-19
intensive care unit (ICU) admissions [24 months]
number of intensive care unit (ICU) admissions for the treatment of SARS

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).