A Pilot Study: Safety and Immunological Response following Intradermal COVID-19 vaccination with Accelerate Regime
- Conditions
- Healthy volunteerCOVID-19vaccinesafetyimmunological responseintradermalAccelerate Regimen
- Registration Number
- TCTR20210904004
- Lead Sponsor
- Health Systems Research Institute (HSRI)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 60
1. Males or females at least 18-60 years of age (inclusive)
2. Have not received any COVID-19 vaccine?
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 history of Chronic respiratory disease, CVD, CKD, CVS, obesity, cancer and DM?
5. Positive result(s) from either antigen test kit.
6. Have received blood transfusion, plasma, blood product, blood component, immunoglobilins, antiviral or antibodies within the last 90 days?
7. Have history of cigarettes smoking, alcohol drinking and history of drug abuse?
8. Being pregnant?
9. have unstable disease or could not control the sysptom?
10. Have history of immunodeficiency or been using immunosuppressant or steriod drugs?
11. 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 Immunological Response 2 wk and 12 wk after complete vaccination IgG level
- Secondary Outcome Measures
Name Time Method Safety 7 days after vaccination Adverse effects