Immunogenicity and safety of CoronaVac vaccine (Covid-19 vaccine) in Thai people with underlying disease

Phase 4

Completed

• Conditions: Diabetes mellitus Cirrhosis solid cancer Hematologic malignancy chronic kidney disease rheumatological disease cardiovascular disease; CoronaVac vaccine immunogenicity covid-19 vaccine

• Registration Number: TCTR20220720001
• Lead Sponsor: Chulabhorn Royal Academy

Brief Summary

need to be explored

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-07-12
• Study Start: 2022-07-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

1. age more than 18 years old 2. Anti-SAR-CoV-2 negative 3. diabetes mellitus or 4. cirrhosis or 5. solid cancer or 6. hematologic malignancy or 7. chronic kidney disease (GFR <60 ml/mi/1.73 m2) 8. rheumatological disease or 9. cardiovascular disease

Exclusion Criteria

1. previous covid-19 vaccination 2. prior other vaccine in 14 days 3. pregnancy 4. lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of geometric mean titer levels to RBD of spike protein compare baseline and 4 weeks after 2nd doses anti-Sar-Cov2

Secondary Outcome Measures

Name	Time	Method
Immunogenicity response 4 weeks after 2nd doses anti-Sar-Cov2