Respiratory diseases
Conditions
Interventions
1370 participants will be included, of which 600 solid organs transplant recipients (100 kidney, 100 liver, 100 heart and 100 lung), 300 cancer patients, 100 hematopoietic stem cells recipients
100 participants with primary immunodeficiency
100 patients with chronic kidney disease, 50 patients with cirrhosis
20 patients with rheumatological disease and 100 participants. immunocompetent (comparator group).
All participants will receive the adsorbed COVID-19 vaccine (CoronaVac), produced by Instituto Butant
before the 2nd dose
28 days after the 2nd dose
6 and 12 months after the last vaccine dose.
For a sample (about 15 participants from each group) the cellular immune response to the vaccine will be analyzed. For this, two blood samples will be coll
Geometric Mean titers (GMT) of antibodies
solicited and unsolicited, local and sy
G12.300.500
Sponsors
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Centro de Farmacovigilância, Segurança Clínica e Gestão de Risco, Instituto Butantan
Eligibility
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: Adults aged from 18 to 59 years, belonging to one of the following groups: Solid organs transplant recipients - kidney, liver, heart and lung; Chronic Kidney disease pre-transplantation; Liver cirrhosis pre-transplantation; Hematopoietic stem cell transplantation; Cancer in active therapy; Adults with innate immunity errors, diseases with predominant antibody deficiency; Immune-mediated rheumatic diseases; Immunocompetent persons (comparator group)
Exclusion criteria
Exclusion criteria: Have previously received any Covid vaccine; History of allergy to any component of the vaccine; Have received any other vaccine up to 15 days before inclusion in the study; Acute illness or fever at the time of inclusion; Behavioral, cognitive or psychiatric illness that, in the opinion of the researchers, affects the ability to understand and collaborate with the requirements of the research protocol Alcohol or drug addiction; Any other condition that, according to the investigator's judgment, may prejudice the study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1: Frequency (%) of seroconversion 28 days after each dose of vaccine, for each participant group. Seroconversion will be defined by the presence of anti-SARS-CoV-2 antibodies after vaccination in participants with an absence of anti-SARS-CoV-2 antibodies before vaccination and / or at least a 4-fold increase in anti-SARS- antibody titers CoV-2 in participants with anti-SARS-CoV-2 antibodies prior to vaccination. ;Expected Outcome 2: Geometric mean titers (GMT) of anti-SARS-CoV-2 antibodies before and 28 days after each dose of vaccine, for each group of participants;Expected Outcome 3: Frequency (%) of seropositivity at six and twelve months after completing the vaccination for each group of participant. ;Expected Outcome 4: Geometric mean titers (GMT) of anti-SARS-CoV-2 antibodies six and twelve months after the last vaccine dose for each group of participants;Expected Outcome 5: Frequency (%) of solicited and unsolicited, local and systemic adverse reactions, up to 7 days after each dose of the vaccine, for each group of participants;Expected Outcome 6: frequency (%) of serious adverse events throughout the study period for each group of participants;Expected Outcome 7: frequency (%) of adverse events of special interest (AESI) throughout the study period for each group of participants | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 8: frequency (%) of virologically-confirmed COVID-19 cases in the participants who received at least one vaccine dose during the entire study period ;Expected Outcome 9: Frequency (%) of seroconversion after vaccination according to previous exposure to the virus in participants who have received at least one dose of the vaccine, for each group of participants ;Expected Outcome 10: Geometric mean of antibodies (GMT) of anti-SARS-CoV-2 antibody after vaccination according to previous exposure to the virus in participants who have received at least one dose of the vaccine, for each group of participants ; Expected Outcome 11: Cellular immune response before vaccination and 4 weeks after completing vaccination in a subgroup of participants, for each group of immunocompromised | — |
Countries
Brazil
Contacts
Public ContactAna Marli Sartori
Outcome results
None listed