Immunogenicity and safety of heterologous and homologous prime-boost schedules with an adenoviral vectored and inactivated SARS-CoV-2 (COVID-19) vaccines

Completed

• Conditions: COVID-19; Inactivated vaccine; Viral vectored vaccine

• Registration Number: TCTR20210913001
• Lead Sponsor: The Royal College of Physicians of Thailand

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-13
• Study Completion: 2022-02-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Thai nationality
2. Received one dose of CoronaVac 3-4 weeks prior or one dose of ChAdOx1-S nCoV-19 4-12 weeks prior

Exclusion Criteria

1. Prior COVID-19 infection
2. Allergic to vaccine or vaccine component
3. Receiving immunosuppressants, immunoglobulin or blood components within 3 months
4. Anatomical or functional asplenia
5. Drug abuse or alcoholism
6. Autoimmune or immunodeficiency diseases
7. Pregnancy or lactation

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity At 28 days after second vaccination SARS-CoV-2 anti-spike IgG titer

Secondary Outcome Measures

Name	Time	Method
Immunogenicity At 28 and 90 days after second vaccination SARS-CoV-2 anti-spike IgG titer, SARS-CoV-2 surrogate neutralizing antibody,Adverse events Within 90 days after second vaccination Patient reported outcome using a questionnaire interview