COPD, post SAR-COV-2 (COVID-19 virus) infection Healthy elderly COPD, post SAR-COV-2 (COVID-19 virus) infection Healthy elderly, COVID-19, immunology
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralizing antibody Baseline and wk 4, 12, 24, 36, 48 post the last dose RU/ml | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Chiang Mai University