Created at Source Raw Value Validated value
Dec. 10, 2021, 2 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "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 Butantan; administered in two doses with 28-day interval.We will collect blood samples from all participants to measure anti-COVID antibodies; in five moments: pre-vaccination; 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 collected; pre-vaccination and 28 days after the 2nd dose.Adverse events; local and systemic; solicited and unsolicited; will be monitored for 7 days after each vaccine dose. Serious adverse events and adverse events of special interest will be monitored throughout the study period (13 months).All participants will be contacted; by phone or eletronic message; monthly; to assess COVID diagnosis or symptoms. The participants will also be instructed to return to the research center in case of symptoms or signs suggestive of the disease to perform PCR-COVIDEach participant will be followed-up for 13 monthsIn the statistic analyses; each one of the immunocompromised group will be compared to the immunocompetent group; in terms of seroconversion rates (%); Geometric Mean titers (GMT) of antibodies; solicited and unsolicited; local and sy;G12.300.500;C25.100;G12.070.500", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "2;Days0-28", "treatment_id": 327, "treatment_name": "Coronavac", "treatment_type": "Inactivated virus", "pharmacological_treatment": "Vaccine"}]