Safety and Immunological Response following heterologous prime-boost primary series and booster COVID-19 vaccinatio
- Conditions
- Healthy volunteersheterologous prime-boostCOVID-19 vaccine
- Registration Number
- TCTR20210720007
- Lead Sponsor
- Faculty of Medicine Siriraj Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 270
1. Males or females at least 18 years of age (inclusive)
2. Have not received COVID-19 vaccine or received 1st dose of COVID-19 vaccine (Inactivated vaccine or AstraZeneca) within 4 weeks
3. Can understand Thai language through speaking, reading and writing
4. Able to communicate through electronic tools such as Google form or line.
5. Capable of attending all study visits according to the study schedule
6. Capable of informed consent and provision of written informed consent before any study procedures
1. Have history of severe drug or vaccine allergy (anaphylaxis)
2. Have detected COVID-19 infection
3. Have history of COVID-19 high risk contact
4. Have received blood transfusion, plasma, blood product, blood components, immunoglobulins, antiviral or antibodies within the last 90 days
5. Have history of cigarettes smoking, alcohol drinking and history of drug abuse
6. Be pregnant
7. Have unstable disease or could not control the symptom
8. Have history of immunodeficiency or use immunosuppressant or steroid drugs
9. Have any unusual symptoms or medical history that considered unable to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse events 7 days after Vaccination and upto 12 weeks after 2nd dose or 2 weeks after 3rd dose amount of adverse events
- Secondary Outcome Measures
Name Time Method Immune reponse 12 weeks after 2nd dose or 2 weeks after 3rd dose IgG level