Safety and Immunogenicity of SARS CoV-2 mRNA vaccine platform in healthy Thai adolescent (COVID-19)
- Conditions
- Prevention of COVID-19 with SARS CoV-2 mRNA vaccine platform, comparing standard dose and low dose, in healthy Thai adolescentSARS-CoV-2, mRNA vaccine, COVID-19 vaccine, Adolescent, Immunogenicity, Reactogenicity
- Registration Number
- TCTR20210917004
- Lead Sponsor
- ational Vaccine Institute
- Brief Summary
Healthy adolescents had good immune responses to the fractional dose regimen of BNT162b2 and this may be considered as an alternative option.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Anti-S-RBD IgG Day 0, day 21, day 35, day 180, day 194, day 360 BIOTEC COVID-19 IgG ELISA,Surrogate virus neutralization test (sVNT) to Beta and Delta strain Day 0, day 21, day 35, day 180 ELISA,T and B cell response Day 0, day 35, day 180 ELISpot,Surrogate virus neutralization test (sVNT) to Delta and Omicron strain Day 180, day 194, day 360 ELISA,Pseudovirus neutralizing antibody (pVNT) to Omicron strain Day 180, day 194, day 360 BIOTEC In-house assay
- Secondary Outcome Measures
Name Time Method Safety 21 days, 35 days, 180 days, 194 days, 360 days Solicited local and systemic adverse events, Unsolicited adverse events