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COVID-19 VACCINE SAFETY AND EFFECTIVENESS

NCT ID: NCT05133609

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-15

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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SARS-CoV-2 Infection

Keywords

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vaccines immunity safety rheumatic diseases covid-19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

ChAdOx1 nCoV-19 vaccine (AZD1222)

Intervention Type BIOLOGICAL

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).

Group 2

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

Group Type EXPERIMENTAL

ChAdOx1 nCoV-19 vaccine (AZD1222)

Intervention Type BIOLOGICAL

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).

Interventions

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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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centro de Pesquisas René Rachou

OTHER_GOV

Sponsor Role collaborator

Federal University of Espirito Santo

OTHER

Sponsor Role lead

Responsible Party

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Valéria Valim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valéria Valim, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Espirito Santo

Locations

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Federal University of Espirito Santo

Vitória, Espírito Santo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Valéria Valim, PhD

Role: CONTACT

Phone: +5527999874665

Email: [email protected]

Facility Contacts

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Valéria Valim, PhD

Role: primary

Other Identifiers

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FUES03

Identifier Type: -

Identifier Source: org_study_id