Trial TCTR20211004001
Publication Intapiboon P, Vaccines, 2021
Funding: Public/non profit (The National Vaccine Institute and the Faculty of Medicine, Prince of Songkhla university, Thailand)
Conflict of interest: no COI
| Methods | |
| RCT | |
| Location :
Single center / Thailand Follow-up duration (months): 1 | |
| BNT162b2 low dose (0.06 mL) intradermal booster (n = 31)
BNT162b2 half dose (0.15 mL) intramuscular booster (n = 30) BNT162b2 standard dose (0.3 mL) intramuscular booster (n = 30) |
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| Inclusion criteria | Thai adults aged 18-60 years; completed two-dose regimen of inactive SARS-CoV-2 vaccine in the past 1 - 3 months; 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; 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; can provide with informed consent and sign informed consent form (ICF). |
| Exclusion criteria | Have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis; Be allergic to any component of the research vaccines or used to have a history of hypersensitivity or serious reactions to vaccination; Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months of after baseline period; Have infectious diseases, including HIV and SARS-CoV-2 infection; Have history of SARS-CoV-2 infection; Have severe chronic diseases or condition in progress cannot be controlled. For examples, poor controlled DM and uncontrolled HT; Have the history of urticaria 1 year before receiving the investigational vaccine; Have known underlying diseases of thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection); Have needle sickness; Have the history of immunosuppressive therapy, cytotoxic therapy or systemic corticosteroids; Have received blood products within 4 months before injection of investigational vaccines; Under anti-tuberculosis treatment; 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 |
| Interventions | |
| Intervention
1 IM half (0.15 mL) dose of BNT162b2 1-3 months after 2-dose primary schedule of Sinovac 1 intradermal low (0.06 mL) dose of BNT162b2 1-3 months after 2-dose primary schedule of Sinovac |
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| Control
1 IM standard (0.3 mL) dose of BNT162b2 1-3 months after 2-dose primary schedule of Sinovac | |
| Participants | |
| Randomized 91 participants | |
| Characteristics of participants Type of participants: Healthy adults N=91 40 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: NR | |
| Description of participants Healthy adults who had reecived 2 doses CoronaVac with no current or known history of SARS-CoV-2 infection at a single center in Thailand | |
| Primary outcome | |
| In the register 1) binding antibodies against SARS-CoV-2 S protein by ELISA, Time point : on day 14, day 28 and month 3 after the booster vaccination; 2) neutralizing antibodies against SARS-CoV-2 RBD (delta variant) by competitive ELISA, Time point : on day 14, day 28 and month 3 after the booster dose | |
| In the report anti-RBD-IgG | |
| Variants description | |
| Variants | |
| Description Prevalence of variants reported narratively and indirectly: “B.1.617.2 (Delta) strain is now one of the main variants found globally, including in Thailand”. Neutralizing antibodies were tested against the Delta variant in all participants. | |
| Documents avalaible |
Protocol NR Statistical plan * Data-sharing stated:
Yes |
| 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 retrospective trial registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan were available at the time of data extraction. The article reports on only three of eight arms included in the registry. It is unclear whether any sample size was predefined for the reported arms. No outcome is identified as primary in the article, but the outcomes in the registry are reported. |