Immunogenicity and Safety Outcome of Homologous and Heterologous Prime-boost of Inactivated Vaccine and Replication-defective Viral Vectors Vaccine Against SARS-CoV2 among Hemodialysis Patients: An Observational Prospective Cohort Trial

Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand0 sites130 target enrollmentMay 16, 2022

Overview

No summary available.

Registry

who.int

Start Date

May 16, 2022

End Date

November 30, 2021

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand

•1\.Participants at least age of 18\-year\-old who has maintenance hemodialysis with stable condition for at least 3 months before the enrollment
•2\.Receives one of the following vaccine regimens
•a.Inactivated vaccine against SARS\-CoV\-2 (Sinovac, CoronaVac) regimen, or
•b.Replication\-defective viral vectors against SARS\-CoV\-2 (AstraZeneca) regimen, or
•c.Heterologous prime boost of inactivated vaccine against SARS\-CoV\-2 (Sinovac, CoronaVac) followed by replication\-defective viral vectors against SARS\-CoV\-2 (AstraZeneca)
•3\.Provided informed consent

•1\.Previously diagnosed COVID\-19 in the past 90 days
•2\.High\-risk epidemiology history within 14 days before enrollment e.g., close contact with index cases or visiting/ living in outbreak area
•3\.Has received other vaccine against SARS\-CoV\-2
•4\.Participating in other vaccine clinical trial
•5\.Receipt of blood products, blood components, or immunoglobulin within the past 90 days
•6\.Receipt of attenuated live vaccine in the past 28 days
•7\.Receipt of inactivated or subunit vaccines in the past 14 days
•8\.Women in lactation, pregnancy, or planned pregnancy during the study period
•9\.Solid and hematological malignancy
•10\.Patients with known Human Immunodeficiency Virus (HIV) infection