Clinical trial NCT05133609: COVID-19 VACCINE SAFETY AND EFFECTIVENESS
Official title: COVID-19 VACCINE SAFETY AND EFFECTIVENESS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: SARS-CoV-2 Infection
Keywords: vaccines
immunity
safety
rheumatic diseases
covid-19
Lead sponsor: Federal University of Espirito Santo
Sponsor class: OTHER
Collaborators: name: Centro de Pesquisas René Rachou
First posted: 2021-11-24
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Viral Neutralization Assay
timeFrame: 7 months
measure: Viral Neutralization Assay
timeFrame: 24 months
Secondary outcomes:
measure: IgM (Immunoglobulin M)
timeFrame: 7 months
measure: IgM (Immunoglobulin M)
timeFrame: 24 months
measure: IgG (Immunoglobulin G)
timeFrame: 7 months
measure: IgG (Immunoglobulin G)
timeFrame: 24 months
measure: IgA (Immunoglobulin G)
timeFrame: 7 months
measure: IgA (Immunoglobulin G)
timeFrame: 24 months
measure: systemic soluble factors
timeFrame: 7 months
measure: systemic soluble factors
timeFrame: 24 months
measure: Antigen-specific stimulation of peripheral blood mononuclear cells
timeFrame: 1 month
measure: Antigen-specific stimulation of peripheral blood mononuclear cells
timeFrame: 6 months
measure: Antigen-specific stimulation of peripheral blood mononuclear cells
timeFrame: 12 months
measure: Antigen-specific stimulation of peripheral blood mononuclear cells
timeFrame: 18 months
measure: Lymphocyte investigation
timeFrame: 1 month
measure: Lymphocyte investigation
timeFrame: 6 months
measure: Lymphocyte investigation
timeFrame: 12 months
measure: Lymphocyte investigation
timeFrame: 18 months
measure: Cytokine investigation
timeFrame: 1 month
measure: Cytokine investigation
timeFrame: 6 months
measure: Cytokine investigation
timeFrame: 12 months
measure: Cytokine investigation
timeFrame: 18 months
measure: Adverse events
timeFrame: 1 month
measure: Adverse events
timeFrame: 4 months
measure: Adverse events
timeFrame: 6 months
measure: severe cases of COVID-19
timeFrame: 24 months
measure: deaths
timeFrame: 24 months
measure: hospital admissions
timeFrame: 24 months
measure: intensive care unit (ICU) admissions
timeFrame: 24 months
Other outcomes:
Locations:
city: Vitoria
country: Brazil
facility: Federal University of Espirito Santo
state: Espirito Santo
Study officials:
affiliation: Federal University of Espirito Santo
name: Valéria Valim, PhD
role: PRINCIPAL_INVESTIGATOR
References: