Immunogenicity against SARS-CoV-2 variants of concern of ChAdOx1 nCoV-19 vaccine, Sinovac's CoronaVac vaccine, heterologous vaccines and the third boosting vaccine in the elderly and COPD patients

Recruiting

• Conditions: COPD,post SAR-COV-2 (COVID-19 virus) infectionHealthy elderly; COPD,; post SAR-COV-2 (COVID-19 virus) infection; Healthy elderly,; COVID-19,; immunology

• Registration Number: TCTR20210822002
• Lead Sponsor: Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-22
• Study Completion: 2022-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Elderly (age >60 years) subjects and spirometry-confirmed COPD patients at any age
2.Receiving any 3 national authorized COVID-19 vaccine regimens (CoronaVac/ChAdOx-1, 2-dose ChAdOx-1 vaccine and 2-dose CoronaVac vaccine)
3.Boosting with either virus-vectored or mRNA vaccine following standard 2-dose of CoronaVac vaccine

Exclusion Criteria

1.No history of previously diagnosed COVID-19 except positive control group
2.No history of COPD exacerbation within previous 3 months
3.High-risk of active infection within 14 days before enrollment e.g. close contact with index cases or visiting/ living in outbreak area
4.History of receiving other vaccines against SARS-CoV-2
5.Participating in other vaccine clinical trial
6.History of receiving blood products, blood components, or immunoglobulin within the past 90 days
7.History of receiving attenuated live vaccine in the past 28 days
8.History of receiving inactivated or subunit vaccines in the past 14 days
9.History of allergy to any vaccine component
10.Underlying uncontrolled diabetes, uncontrolled cardiovascular disease, uncontrolled pulmonary disease, end-stage renal disease requiring dialysis, cirrhosis, immunocompromised host or receiving immunosuppressive agents
11.Unable to make the decision and sign consent by themselves

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eutralizing antibody Baseline and wk 4, 12, 24, 36, 48 post the last dose RU/ml

Secondary Outcome Measures

Name	Time	Method
Cell-mediated immunity (CMI) Baseline and wk 4, 12, 24, 36, 48 post the last dose percent of positive cell,Cell-mediated immunity (CMI) Baseline and wk 4, 12, 24, 36, 48 post the last dose Mean fluorescent intensity