Prevention of COVID-19 with heterologous prime-boost SARS-CoV-2 vaccine with inactivated and mRNA vaccine platforms, comparing standard dose vs low dose and 3-week vs 6-week interval, in healthy Thai adolescent. SARS-CoV-2, mRNA vaccine, Inactivated SARS-CoV-2 vaccine, COVID-19 vaccine, Adolescent, Immunogenicity, Reactogenicity
Conditions
Interventions
- CoronaVac 0.5 ml
- BNT162b2 30 ug
21 days apart,- CoronaVac 0.5 ml
- BNT162b2 20 ug
21 days apart,- CoronaVac 0.5 ml
- BNT162b2 30 ug
42 days apart,- CoronaVac 0.5 ml
- BNT162b2 20 ug
42 days ap
Active Comparator Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Experimental Biological/Vaccine,Act
CoronaVac/BNT162b2,CoronaVac/BNT162b2,CoronaVac/BNT162b2,CoronaVac/BNT162b2,10-ug BNT162b2 booster,15-ug BNT162b2 booster,30-ug BNT162b2 booster
Sponsors
National Vaccine Institute
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Participants must age 12 to <18 years old. 2. Participants have never received vaccination against SARS-CoV-2 prior to study enrollment. 3. Participants must be in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator. 4. Participants must be able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirements. 5. Participants and/or parent(s) or legally authorized representative(s) must sign a written informed consent form, including any required privacy authorization form, prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
Exclusion criteria
Exclusion criteria: 1. Known anaphylaxis to any of the trial vaccine components (including excipients of the trial vaccines) or drugs. 2. Participants with previous documented SARS-CoV-2 infection within 6 months of first vaccination. 3. Receipt of immunoglobulins or blood products within 3 months of first vaccination. 4. Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial. 5. Use of or anticipated need to use, within the next 6 months of any medications that may be associated with impaired immune responsiveness or with immunosuppression. 6. Participants who are pregnant or breastfeeding. 7. Presence of any acute illness required medical attention within 14 days of first vaccination. 8. Participants with body mass index more than 35 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-S-RBD IgG Day 0, day 21/42, day 35/56, day 90/120, day 180, day 194, day 360 BIOTEC COVID-19 IgG ELISA,Surrogate virus neutralization test (sVNT) to variants of concern e.g. Delta strain Day 0, day 21/42, day 35/56, day 90/120, day 180, day 194, day 360 ELISA,T and B cell response Day 35/56, day 90/120, day 180 ELISpot,Pseudovirus neutralizing antibody (pVNT) to Omicron strain Day 180, day 194, day 360 BIOTEC In-house assay | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Day 21/42, day 35/56, day 90/120, day 180, day 194, day 360 Solicited local and systemic adverse events, Unsolicited adverse events | — |
Countries
Thailand
Contacts
Public ContactProf. Thanyawee Puthanakit
Department of Pediatrics, Faculty of Medicine, Chulalongkorn University
Outcome results
None listed