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Clinical Trials/RBR-9ksh5f4
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.

Registry
who.int
Start Date
May 26, 2021
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Intervention

Investigators

Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

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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