Trial RPCEC00000354
Publication Toledo-Romani ME, medRxiv, 2022
Dates: 2021-03-08 to 2021-03-31
Funding: Public/non profit (Finlay Vaccine Institute, Biocubafarma and Fondo Nacional de Ciencia y Tecnica)
Conflict of interest: Yes
| Methods | |
| RCT | |
| Location :
Multicenter / Cuba Follow-up duration (months): 5.4 | |
| SOBERANA 02, 2 doses (n = 14679) SOBERANA 02, 2 doses + SOBERANA Plus booster (n = 14 677) Placebo (n = 14675) | |
| Inclusion criteria | 1. Subjects who give their informed consent to participate in the study in writing; 2. Subjects aged between 19 and 80 years; 3. Women of childbearing age who use contraceptive methods during the study and are willing to use them up to 3 months after the corresponding vaccination schedule has concluded. |
| Exclusion criteria | 1. Subjects with acute febrile or infectious disease in the 7 days prior to the administration of the vaccine or at the time of its application; 2. Subjects with diminished mental faculties for decision making; 3. Subjects with a history of hypersensitivity to thiomersal or to some of the components of the formulation; 4. Previous or current history of SARS-CoV-2 infection (questioning); 5. Application of vaccines containing tetanus toxoid in the last 3 months; 6. Subjects previously vaccinated against SARS-CoV-2; 7. Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, Biomodulin T, any gamma globulin, Levamisole, Heberferon, thymosin) or other drugs with immunomodulatory action. In addition, those people who, due to their underlying disease, require immunomodulatory treatment during the development of the study; 8. Pregnancy, puerperium or lactation; 9. Subjects with tattoos in the deltoid region on both arms; 10. Decompensated chronic diseases that limit vaccination according to clinical criteria; 11. HIV subjects with detectable viral load, history of opportunistic infection or CD4 less than 200 copies; 12. Subjects with unstabilized malignant disease or who are receiving cytostatic treatment and / or radiotherapy during the time of the study or have been receiving it in the last three months. |
| Interventions | |
| Intervention
2 IM doses of 25 mcg, 28 days apart |
|
| Control
2 IM doses of placebo, 28 days apart | |
| Participants | |
| Randomized 44031 participants | |
| Characteristics of participants Type of participants: Adults N=44031 13998 males Children: 0 Pregnant women: 0 Immunocompromized patients: 1742 Mean age: Age range: 18-81 | |
| Description of participants Adults in medically stable condition with no self-reported previous COVID-19 infection at 48 centers in Cuba | |
| Primary outcome | |
| In the register Virologically confirmed symptomatic infection of Covid-19. Measurement time: from 14 days after the last dose of the candidate until 3 months after this evaluation. | |
| In the report VE in preventing occurrence of symptomatic COVID-19 confirmed by positive SARS-CoV-2 RT-PCR nasopharyngeal swab (RT-PCR), with onset at least 14 days after the last injection | |
| Variants description | |
Variants
| |
| Description Predominance of VOC Beta(epidemiological week 16 to 22: 83·7% to 72·5%). During So2P efficacy evaluation the Beta strain was partially replaced by Delta (epidemiological week 22 to 28: 72·5% to 29·2% Beta; 5·9% to 70·8% Delta). | |
| Documents avalaible |
Protocol NR Statistical plan * Data-sharing stated:
Yes, After publication in specialized journals |
| 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 prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available, but will be available upon publication. The trial (n = 44031) achieved its target sample size (44010). This trial was updated on November 14th 2022 after finals results for the trial were available (pre-print). |