RBR-9ksh5f4
Not yet recruiting
Phase 4
Phase IV study to evaluate the safety and immunogenicity of the Covid-19 adserbed (inactivated) vaccine of the Instituto Butantan in immunocompromised hosts
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo0 sitesMay 26, 2021
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Respiratory diseases
- Sponsor
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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