Immunogenicity and safety of ChAdOx1 vaccine (Covid-19 vaccine) in Thai people with underlying disease

Phase 4

Completed

• Conditions: Diabetes mellitusCirrhosissolid cancerHematologic malignancychronic kidney diseaserheumatological diseasecardiovascular disease; ChAdOx1 vaccine; immunogenicity; covid-19 vaccine

• Registration Number: TCTR20211228003
• Lead Sponsor: Chulabhorn Royal Academy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-07-12
• Study Start: 2021-12-28
• 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 28 days and 180 days after 2 nd dose vaccination anti-Sar-Cov2

Secondary Outcome Measures

Name	Time	Method
Immunogenicity response 56 days after 1st dose vaccination anti-Sar-Cov2,Immunogenicity response 90 days after 1st dose vaccination anti-Sar-Cov2,Immunogenicity response 28 days after 2nd dose vaccination anti-Sar-Cov2,Immunogenicity response 6 months after 2nd dose vaccination anti-Sar-Cov2