COVID-19 VACCINE SAFETY AND EFFECTIVENESS

SARS-CoV-2 Infection Clinical Trial

Official title:

COVID-19 VACCINE SAFETY AND EFFECTIVENESS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133609
• Other study ID #: FUES03
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 15, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2021
• Source: Federal University of Espirito Santo
• Contact: Valéria Valim, PhD
• Phone: +5527999874665
• Email: val.valim[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 30, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

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).

Locations

Country	Name	City	State
Brazil	Federal University of Espirito Santo	Vitoria	Espirito Santo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Espirito Santo	Instituto René Rachou/Fiocruz

Country where clinical trial is conducted

Brazil, 

Outcome

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