An outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was dispersed in many countries, which subsequently resulting in global pandemic. According to the contagious and virulence profile of this virus, it was contributed to high morbidity and mortality among patients who were infected. The risk of mortality from COVID-19 disease appears to be higher in patients with aged over 70 years old, taking immunosuppressive agents and whom with pre-existing medical comorbidi
Conditions
Interventions
All eligible participants will be assessed for general demographic data, and hemodialysis data. The immunogenicity of SARS-CoV-2 vaccination, and the laboratory assessment which might associated with
Homologous inactivated vaccine against SARS-CoV-2 (Sinovac/ CoronaVac) regimen, SV-SV,Homologous replication-defective viral vectors against SARS-CoV-2 (AstraZeneca) regimen, AZ-AZ,Heterologous prime
Sponsors
Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
The kidney foundation of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of participant who has seroconversion of neutralizing antibodies to live SARS-CoV-2 at day 28 after the second dose of each vaccine regimen at 4 weeks after second vaccination Percentage of neutralizing antibody | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the geometric mean titers (GMTs) of neutralizing antibodies to live SARS-CoV-2, RBD-specific IgG, and S-specific IgG at specific timepoint of each vaccine regimen 4 weeks after first vaccination, pre-second vaccination, and 4 weeks after second vaccination SARS-CoV2 anti-RBD IgG assay, and SARS-CoV-2 NeutraLISA surrogate neutralization assay ,To determine factors associated with seroconversion 4 weeks after the second vaccination Logistic regression,To determine the safety endpoint which are the frequency and intensity of local and systemic adverse events of each vaccine regimen after the first, and second vaccination Vaccine diary | — |
Countries
Thailand
Contacts
Public ContactPhoom Narongkiatikhun
Faculty of Medicine, Chiang Mai University
Outcome results
None listed