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

Completed

• Registration Number: TCTR20220516002
• Lead Sponsor: Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-11-30
• Study Start: 2022-05-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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