Trial NCT05142319
Publication Poh XY, Clin. Infect. Dis., 2022
Dates: 2021-10-01 to 2021-11-30
Funding: Public/non profit (Singapore National Medical Research Council; US Food and Drug Administration Medical Countermeasures Initiative; Medical Research Council (UK))
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Single center / Singapore Follow-up duration (months): 1 | |
| BNT162b2/boost BNT162b2 (n = 51) BNT162b2/boost mRNA-1273 (n = 49) |
|
| Inclusion criteria | Individuals who received BNT162b2 as their primary vaccine series at least six months earlier; Willing and able to provide informed consent for participation in this study; Aged ≥21years at the time of study enrolment; Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures. |
| Exclusion criteria | History of known SARS-CoV-1 or SARS-CoV-2 infection; immunocompromising medical condition (e.g. active leukemia or lymphoma, generalized malignancy, aplastic anemia, solid organ transplant, bone marrow transplant, current radiation therapy, congenital immunodeficiency, HIV/AIDS with CD4 lymphocyte count < 200 cells/mm3 and patients on immunosuppressant medications); Known history of SARS-CoV-2 or SARS-CoV-1 infection; Previously received an investigational coronavirus vaccine; Previously received a SARS-CoV-2 monoclonal antibody; Current or planned simultaneous participation in another interventional study; A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a COVID-19 vaccine, or otherwise have a contraindication to one of the available study vaccines per the approved label; Individuals who are immunocompromised (e.g. active leukaemia or lymphoma, generalised malignancy, aplastic anaemia, solid organ transplant, bone marrow transplant, current radiation therapy congenital immunodeficiency, HIV/AIDS with CD4 lymphocyte count < 200 and patients on immunosuppressant medications); Received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids >/= 20 milligram per day of prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior to Day 1; Individuals who are pregnant or breast feeding; Chronic illness that, in the opinion of the study team, is at a stage where it might interfere with trial conduct or completion; Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalised involuntarily; Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures in the opinion of the study team; Moderate or severe acute illness/infection (according to study team's judgement) on the day of vaccination, or febrile illness (temperature ≥ 37.5°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. |
| Interventions | |
| Intervention
1 IM dose of 50 mcg mRNA-1273 at least 6 months after primary BNT162b2 schedule |
|
| Control
1 IM dose of 30 mcg BNT162b2 at least 6 months after primary BNT162b2 schedule | |
| Participants | |
| Randomized 100 participants | |
| Characteristics of participants Type of participants: Adults N=100 43 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 23-84 | |
| Description of participants Adults at a single center in Singapore with no previous history of COVID-19 who had received a primary series of BTN162b2 at least 6 months previously | |
| Primary outcome | |
| In the register SARS-CoV-2 anti-spike immunoglobulins [ Time Frame: Day 28 ] To determine the presence and levels of anti-SARS-COV-2 in human sera | |
| In the report Whether a heterologous mRNA-1273 COVID-19 vaccine booster leads to non-inferior humoral immunity against wild-type SARSCoV-2 and/or VOCs at day 28 compared with homologous BTN162b2 | |
| Variants description | |
| Variants | |
| Description * | |
| 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 pre-print article, the trial registry and supplementary appendices were used in data extraction and assessment of risk of bias. At the time of extraction neither protocol nor statistical analysis plan was available. The trial (n = 100) did not achieve its target sample size (n = 174). The article presented a prelimary analyses (with recuitment complete) for a study with ongoing follow-up. This trial was updated on June 17th, 2022 after publication of study report. |