There were several strategies to improve the prevention of infection including mixing and switching vaccination during the shortage of supply, chemoprophylaxis and boosting the immunity against this virus. The Strategies on vaccine prioritization and mass dispensing was not suitable in the countries with insufficient volume of vaccination supply and limited types of vaccine. The data on chemoprophylaxis with ivermectin is still unclear. Here the purpose of this current study focuses on the
Conditions
Interventions
Comparator: homogeneous boost arm with ChAdOx1 nCoV-19 (Oxford-AstraZeneca)
Intramuscular route: 0.5 ml 4-8 weeks after completed SV vaccination,Experimental: homogeneous boost arm with ChAdOx1 nCoV-19 (Oxford-AstraZeneca)
Intradermal route: 0.1 ml 4-8 weeks after completed SV vaccination,Experimental: homogeneous boost arm with ChAdOx1 nCoV-19 (Oxford-AstraZeneca)
Intradermal route: 0.1 ml more than 8-12 weeks after completed SV vaccination,Comparator: homogeneous boost arm with ChAdOx1 nCoV-19 (Oxford-AstraZeneca)
Intramuscular route: 0.15 ml 4-8 weeks after completed SV vaccination,Comparator: homogeneous boost arm with BNT162b2 (Pfizer-BioNTech)
Intramuscular route: 0.3 ml,Experimental: homogeneous boost arm with BNT162b2 (Pfizer-BioNTech)
Intramuscular route: 0.15 ml at least 4 weeks after completed SV vaccination,Experimental: homogeneous boost arm with BNT162b2 (Pfizer-BioNTech)
Intradermal route: 0.06 ml at least 4 weeks after completed SV vaccination,Experimental: homogeneous boost arm with CoronaVac (Sinovac)
Intradermal route: 0.1 ml at least 4 weeks after completed SV vaccination
Health Services Research,Health Services Research,Health Services Research,Health Services Research,Health Services Research,Health Services Research,Health Services Research,Health Services Research
SV1 SV2 AZ IM 4-8 weeks,SV1 SV2 AZ ID 4-8 weeks ,SV1 SV2 AZ ID more than 8-12 weeks ,SV1 SV2 AZ IM half dose 4-8 weeks,SV1 SV2 Pfizer IM full dose ,SV1 SV2 Pfizer IM half dose,SV1 SV2 Pfizer ID 1/5 do
Sponsors
faculty of medicine, Prince of songkla university
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Thailand
Contacts
Public ContactSupattra Uppanisakorn
PSU-CRC
Outcome results
None listed