COVID-19 VACCINE SAFETY AND EFFECTIVENESS
1 other identifier
interventional
550
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2021
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2021
CompletedFirst Submitted
Initial submission to the registry
November 1, 2021
CompletedFirst Posted
Study publicly available on registry
November 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2023
CompletedNovember 24, 2021
November 1, 2021
1.5 years
November 1, 2021
November 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (27)
IgM (Immunoglobulin M)
7 months
IgM (Immunoglobulin M)
24 months
IgG (Immunoglobulin G)
7 months
IgG (Immunoglobulin G)
24 months
IgA (Immunoglobulin G)
7 months
- +22 more secondary outcomes
Study Arms (2)
Group 1
EXPERIMENTALHealth professionals who will receive vaccine in the vaccination campaign against SARS-CoV-2.
Group 2
EXPERIMENTALPatients with immune-mediated inflammatory diseases who will receive vaccine in the vaccination campaign against SARS-CoV-2.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Age 18 years or older
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Espirito Santo
Vitória, Espírito Santo, 29041-295, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valéria Valim, PhD
Federal University of Espirito Santo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 1, 2021
First Posted
November 24, 2021
Study Start
January 15, 2021
Primary Completion
August 1, 2022
Study Completion
December 30, 2023
Last Updated
November 24, 2021
Record last verified: 2021-11