Immunogenicity and safety of an intradermal boost in healthy general population; preliminary study. (COVID-19)
- Registration Number
- TCTR20211004001
- Lead Sponsor
- faculty of medicine, Prince of songkla university
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
1. Thai adults aged 18-60 years, who have been completed two-dose regimen of inactive SARS-CoV-2 vaccine in the past 1 - 3 months
2. The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 3-month follow-up of the study.
3. Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization
4. The subject can provide with informed consent and sign informed consent form (ICF).
1. Have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
2. Be allergic to any component of the research vaccines or used to have a history of hypersensitivity or serious reactions to vaccination.
3. Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months of after baseline period.
4. Have infectious diseases, including HIV and SARS-CoV-2 infection.
5. Have history of SARS-CoV-2 infection
6. Have severe chronic diseases or condition in progress cannot be controlled. For examples, poor controlled DM and uncontrolled HT.
7. Have the history of urticaria 1 year before receiving the investigational vaccine.
8. Have known underlying diseases of thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
9. Have needle sickness.
10. Have the history of immunosuppressive therapy, cytotoxic therapy or systemic corticosteroids
11. Have received blood products within 4 months before injection of investigational vaccines.
12. Under anti-tuberculosis treatment.
13. Not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social or other conditions.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immunogenicity on day 14, day 28 and month 3 after the booster vaccination measure binding antibodies against SARS-CoV-2 S protein by ELISA ,Immunogenicity on day 14, day 28 and month 3 after the booster dose measure neutralizing antibodies against SARS-CoV-2 RBD (delta variant) by competitive ELISA
- Secondary Outcome Measures
Name Time Method Safety on day 14 and 28 after the booster vaccination detected by ELISPOT measure specific T cell responses ,Safety within 28 days after the booster dose observe incidence of adverse reactions