Trial jRCT2031210470
Publication Shinkai M, Vaccine, 2022
Dates: 2021-12-03 to 2021-12-22
Funding: Mixed (Shionogi & Co., Ltd.; Ministry of Health, Labour and Welfare (MHLW), Japan; Japan Agency for Medical Research and Development (AMED))
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Single center / Japan Follow-up duration (months): 1 | |
| S-268019 booster (n = 101) BNT162b2 booster (n = 103) |
|
| Inclusion criteria | 20 years or older; had received the second dose of tozinameran (BNT162b2 Pfizer/BioNTech mRNA vaccine) ≥6 months ago; could provide signed informed consent form; male participants had to refrain from donating sperm for ≥180 days after study intervention and either remain abstinent from heterosexual intercourse or use contraceptives; female participants were eligible in the absence of pregnancy or breastfeeding and if they were not of childbearing potential or satisfied all the following conditions: used effective contraceptive method with a failure rate of <1% per year from 30 days before and ≥180 days after study intervention, agreed not to donate ova (eggs or oocytes) for the purpose of reproduction during the period from the study intervention through ≥180 days after the study intervention, and negative pregnancy test during screening |
| Exclusion criteria | Tested positive for SARS-CoV-2 infection as determined by SARS-CoV-2 antigen test at screening; History of SARS-CoV-2 infection, as determined in the interview before the study intervention; Body temperature of 37.5°C or higher on the day of study intervention; Receiving anticoagulation therapy or having thrombocytopenia or coagulopathy; History of convulsion; Current history of poorly controlled cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disease that, in the opinion of the investigator or subinvestigator, would constitute a safety concern or confound data interpretation; Immunosuppressed individuals who are immunocompromised, have acquired immunodeficiency syndrome, received steroids and systemic immunosuppressants within 6 months prior to the study intervention, are being treated for malignant tumor, or are on other immunosuppressive therapy; Individuals considered having hypersensitivity to any of the study interventions or components thereof, or drug or other allergy that, in the opinion of the investigator or subinvestigator, contraindicates participation in the study, except for pollinosis and atopic dermatitis; Experienced serious adverse reactions to tozinameran in the past, including myocarditis and pericarditis; Having a contraindication to intramuscular injections or blood draws; Previous SARS-CoV-2 vaccination with an approved or investigational product, except for tozinameran; Any inactivated vaccine received within 14 days prior to the study intervention; Any live vaccine received within 28 days prior to the study intervention; Anti-SARS-CoV-2 monoclonal antibody, immunoglobulin preparations, blood products, or a blood transfusion within 3 months prior to the study intervention; Current enrollment or past participation within the last 30 days before signing of informed consent form of this study in any other clinical study involving an investigational study intervention or any other type of medical research; Exposure to four or more new chemical entities within 12 months before the study intervention; Ineligibility for the study as considered by the investigator or subinvestigator |
| Interventions | |
| Intervention
1 IM 10 mcg S-268019-b booster, at least 6 months after prime BNT162b2 schedule |
|
| Control
1 IM 30 mcg BNT162b2 booster, at least 6 months after prime BNT162b2 schedule | |
| Participants | |
| Randomized 204 participants | |
| Characteristics of participants Type of participants: Adults N=204 143 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 21-59 | |
| Description of participants Adults who had received 2 doses of BNT162b2 vaccine at least 6 months earlier with no history of SARS-CoV-2 infection at a single centre in Japan | |
| Primary outcome | |
| In the register SARS-CoV-2 neutralizing antibody titer on Day 29 | |
| In the report day 29 geometric mean titer (GMT) and seroresponse rate (SRR) for SARS-CoV-2 neutralizing antibodies | |
| Variants description | |
| Variants | |
| Description No efficacy outcomes. Immuogenicity results against variants Delta and Omicron | |
| 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 pre-print, 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 outcome in the article reflected that in the registry. The trial (n = 204) achieved its target sample size (n = 204).
This study was updated on September 19th, 2022 after publication of the study report. |