Immunogenicity after booster dose with mRNA BNT162b2 among elderly or adult with underlying diseases who had received AZD1222 using standard versus low dose via intramuscular route (COVID-19)
- Conditions
- Prevention of COVID-19 with booster SARS-CoV-2 vaccine using BNT162b2, comparing standard dose vs low dose, in elderly or adult with underlying diseases.SARS-CoV-2, mRNA vaccine, ChAdOx1 nCoV-19 vaccine, Immunogenicity, Reactogenicity
- Registration Number
- TCTR20211027002
- Lead Sponsor
- ational Vaccine Institute
- Brief Summary
The fractional low-dose BNT162b2 mRNA booster vaccine provided non-inferior immunogenicity responses. During a shortage of vaccine supply, a fractional low dose should be considered for a booster vaccination program.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
1.Participants must age 18 to 69 years old on the day of vaccination and meet either cohort inclusion criteria.
oCohort 1: Participants must age 60 to 69 years old on the day of vaccination.
oCohort 2: Participants must have underlying disease e.g., diabetes mellitus, chronic kidney disease, cardiovascular disease.
oCohort 3: Participants must be considered immunocompromised e.g., currently taking immunosuppressant, active cancer currently on treatment.
oCohort 4 (Control): Participants must age 18 to 59 years old and 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.
2.Participants must have received 2 doses of AZD1222 vaccination with interval at least 8 weeks apart.
3.Participants must have received 2nd dose of AZD1222 for more than 60 days at the day of vaccination.
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 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 vaccination day by history obtained from participant(s) and/or positive anti-nucleocapsid test(s).
3.Receipt of immunoglobulins or blood products within 3 months on the day of 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Surrogate virus neutralization test (sVNT) to variants of concern e.g. Delta strain Day 0, day 14, day 90 ELISA
- Secondary Outcome Measures
Name Time Method Anti-S-RBD IgG Day 0, day 14, day 90 BIOTEC COVID-19 IgG ELISA,T cell response Day 0, day 14, day 90 ELISpot,Safety Day 14, day 90 Solicited local and systemic adverse events, Unsolicited adverse events