Immunogenicity and safety of the third dose COVID-19 vaccine via intradermal compare with intramuscular administration (Randomized controlled trial)
Phase 2
Recruiting
- Conditions
- The immune response after the third dose of the COVID-19 vaccine via intradermal administration in healthy volunteers.COVID-19 vaccine, Third dose, intradermal, ChAdOx1, coronavac, Sinovac, BNT162b2, mRNA1263, Sinopharm
- Registration Number
- TCTR20210731003
- Lead Sponsor
- Chulabhorn Royal Academy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 960
Inclusion Criteria
1. 18 years old or more 2. No history of a severe allergic reaction to the prior vaccine. 3. No fever nor history of fever within 14 days. 4. No symptoms of respiratory tract infection within 14 days. 5. Received two doses of COVID-19 vaccine for at least 3 months 6. sign informed consent to the study.
Exclusion Criteria
1. pregnancy. 2. lactation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Humoral immunity 2 weeks after third dose 2 weeks after the third 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 Safety profile after vaccination in each intervention arms 1 weeks after the third dose of the vaccine Solicited and non-solicited adverse events,Humoral immunity 2 weeks after third dose 1 weeks after the third dose of the vaccine Surrogate Neutralizing antibody ,Humoral immunity 2 weeks after third dose 2 weeks after the third dose of the vaccine Neutralizing antibody,Cell mediated respons 2 weeks after the third dose of the vaccine Interferon gamma releasing assay