Trial TCTR20210923012
Publication Puthanakit T, Vaccine: X, 2022
Dates: 2021-10-17 to 2021-10-30
Funding: Public/non profit (National Vaccine Institute, Thailand ; Chulalongkorn University ; Department of Diseases Control, Ministry of Public Health, Thailand.)
Conflict of interest: no COI

Methods
RCT
Location : Single center / Thailand
Follow-up duration (months): 6.4
CoronaVac 3 mcg (0.5mL)/BNT162b2 30 mcg (0.3mL), 3 week interval (n = 20)
CoronaVac 3 mcg (0.5mL)/BNT162b2 20 mcg (0.2mL), 3 week interval (n = 17)
CoronaVac 3 mcg (0.5mL)/BNT162b2 30 mcg (0.3mL), 6 week interval (n = 20)
CoronaVac 3 mcg (0.5mL)/BNT162b2 20 mcg (0.2mL), 6 week interval (n = 19)
Inclusion criteria
  • Aged 12 to <18 years old
  • never received vaccination against SARS-CoV-2 prior to study enrollment
  • 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
  • able to communicate effectively with study personnel and considered reliable, willing, and cooperative in terms of compliance with the protocol requirements
  • 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
  • Known anaphylaxis to any of the trial vaccine components (including excipients of the trial vaccines) or drugs
  • previous documented SARS-CoV-2 infection within 6 months of first vaccination
  • receipt of immunoglobulins or blood products within 3 months of first vaccination
  • receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial
  • 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
  • pregnant or breastfeeding
  • presence of any acute illness required medical attention within 14 days of first vaccination
  • body mass index more than 35 kg/m2
Interventions
Intervention
1 IM dose of CoronaVac 3 mcg (0.5mL) and 1 IM dose of BNT162b2 20 mcg (0.2mL, 3 weeks apart
1 IM dose of CoronaVac 3 mcg (0.5mL) and 1 IM dose of BNT162b2 30 mcg (0.3mL), 6 weeks apart
1 IM dose of CoronaVac 3 mcg (0.5mL) and 1 IM dose of BNT162b2 20 mcg (0.2mL), 6 weeks apart
Control
1 IM dose of CoronaVac 3 mcg (0.5mL) and 1 IM dose of BNT162b2 30 mcg (0.3mL), 3 weeks apart
Participants
Randomized
76 participants
Characteristics of participants
Type of participants: Adolescents
N=76
48 males
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: NR
Description of participants
Healthy adolescents with no prior COVID-19 infection or vaccination at a single center in Thailand.
Primary outcome
In the register
1. Anti-S-RBD IgG Metric / Method of measurement : BIOTEC COVID-19 IgG ELISA Time point : Day 0, day 21/42, day 35/56, day 90/120, day 180, day 194, day 360; 2. Surrogate virus neutralization test (sVNT) to variants of concern e.g. Delta strain Metric / Method of measurement : ELISA Time point : Day 0, day 21/42, day 35/56, day 90/120, day 180, day 194, day 360; 3. T and B cell response Metric / Method of measurement : ELISpot Time point : Day 35/56, day 90/120, day 180; 4. Pseudovirus neutralizing antibody (pVNT) to Omicron strain Metric / Method of measurement : BIOTEC In-house assay Time point : Day 180, day 194, day 360
In the report
GMRs of sVNT against Delta variant and anti-S-RBD IgG-wild type at 14 days after primary vaccination series of each group using SV3w/PZ30 as the reference arm.
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes
Data accessibility: Data will be made available on request. Corresponding author: Thanyawee Puthanakit - thanyawee.p@chula.ac.th
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to the published article, the trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcomes in the article reflect two of those in the registry; cellular response was a primary outcome in the registry, but not described as such in the report. The trial (n = 76) achieved its minimum target sample size (n = 68).