Study to evaluate the effects of the COVID-19 (inactivated) vaccine of the Instituto Butantan in immucompromised persons

Phase 4

• Conditions: Respiratory diseases; COVID-19; Immunocompromised hosts; Transplant recipients; Chronic kidney disease; Liver cirrhosis; Neoplasms; Primary immunodeficiency diseases; C01.918

• Registration Number: RBR-9ksh5f4
• Lead Sponsor: Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-26
• Last Update Posted: 29 May 2023
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified