Immunogenicity and the safety of the COVID-19 vaccines available in Thailand.

Phase 2

Recruiting

• Conditions: The immune response after COVID-19 vaccine administration in healthy volunteers.; COVID-19 vaccine, Sputnik V, ChAdOx1, coronavac, Sinovac.

• Registration Number: TCTR20210517006
• Lead Sponsor: Chulabhorn Royal Academy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-17
• Study Completion: 2021-07-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

1. 18 years old or more
2. negative for blood SARS-CoV-2 antibody
3. negative for nasopharynx PCR for SARS-CoV-2
4. Negative urine pregnancy test (in case of potential of pregnancy)
5. No history of a severe allergic reaction to the prior vaccine.
6. No fever nor history of fever within 14 days.
7. No symptom of respiratory tract infection within 14 days.
8. ECOG 0,1
9. sign informed consent to the study.

Exclusion Criteria

1. prior COVID-19 vaccination.
2. Vaccination with any vaccines within 30 days
3. administration of steroid or receive immunoglobulins within 30 days
4. Receive immunosuppression agent within 30 days.
5. pregnancy.
6. lactation.
7. acute coronary syndrome in the past year.
8. Acute stroke in the past year.
9. Splenectomy
10. active chronic infectious disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody level of total antibody of spike protein of SARS-CoV-2 1 month after the second dose of the vaccine Double antigen technique for detection of Antibody level of total antibody of spike protein of SARS-CoV-2

Secondary Outcome Measures

Name	Time	Method
sustainability of antibody level 12 month after the second dose of the vaccine Double antigen technique for detection of Antibody level of total antibody of spike protein of SARS-CoV-2,proportion of seroconversion after vaccination 1 month after the second dose of the vaccine Double antigen technique for detection of Antibody level of total antibody of spike protein of SARS-CoV-2,T cell respond after vaccination 1 month after the second dose of the vaccine interferon gamma releasing assay,seroprevalence of adenovirus infection Before vaccination. Qualitative measurement of adenovirus antibody.,proportion of the volunteers had four-fold rising of antibody level after vaccination 1 month after the second dose of the vaccine Double antigen technique for detection of Antibody level of total antibody of spike protein of SARS-CoV-2