COVID-19 VACCINE SAFETY AND EFFECTIVENESS

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.

Study Overview

• Status: Recruiting
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Biological: ChAdOx1 nCoV-19 vaccine (AZD1222)

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 Type: Interventional
• Enrollment (Anticipated): 550
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Valéria Valim, PhD; Phone Number: +5527999874665; Email: val.valim@gmail.com

Study Locations

• Brazil
  • Espirito Santo
    • Vitoria, Espirito Santo, Brazil, 29041-295
      • Recruiting
      • Federal University of Espirito Santo
      • Principal Investigator: José G Mill, PhD
      • Principal Investigator: Olindo A Martins Filho, PhD
      • Principal Investigator: Ketty LLL Machado, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IgM (Immunoglobulin M)	Determination of specific IgM profile. Results will be expressed in fluorescence intensity or pg/ml.	7 months
IgM (Immunoglobulin M)	Determination of specific IgM profile. Results will be expressed in fluorescence intensity or pg/ml.	24 months
IgG (Immunoglobulin G)	Determination of specific IgG profile. Results will be expressed in fluorescence intensity or pg/ml.	7 months
IgG (Immunoglobulin G)	Determination of specific IgG profile. Results will be expressed in fluorescence intensity or pg/ml.	24 months
IgA (Immunoglobulin G)	Determination of specific IgA profile. Results will be expressed in fluorescence intensity or pg/ml.	7 months
IgA (Immunoglobulin G)	Determination of specific IgA profile. Results will be expressed in fluorescence intensity or pg/ml.	24 months
systemic soluble factors	Dosage of soluble systemic factors (chemokines, cytokines and growth factors). Results will be expressed in pg/ml.	7 months
systemic soluble factors	Dosage of soluble systemic factors (chemokines, cytokines and growth factors). Results will be expressed in pg/ml.	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.	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.	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.	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.	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.	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.	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.	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.	18 months
Cytokine investigation	Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.	1 month
Cytokine investigation	Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.	6 months
Cytokine investigation	Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.	12 months
Cytokine investigation	Investigation of intracytoplasmic cytokines. The results will be expressed in percentage positive frequency for a specific cell phenotype.	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.	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.	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.	6 months
severe cases of COVID-19	incidence of severe cases of COVID-19 over 20 months following treatment	24 months
deaths	Number of deaths with specific ICD for covid-19	24 months
hospital admissions	number of hospital admissions for covid-19	24 months
intensive care unit (ICU) admissions	number of intensive care unit (ICU) admissions for the treatment of SARS	24 months

Collaborators and Investigators

• Sponsor: Federal University of Espirito Santo
• Collaborators: Instituto René Rachou/Fiocruz

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): November 24, 2021

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: safety; covid-19; immunity; rheumatic diseases; vaccines
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: FUES03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No