Trial RPCEC00000340; RPCEC00000347
Publication Toledo-Romani ME, Vaccine, 2022
Dates: 2020-11-02 to 2021-01-06
Funding: Public/non profit (Finlay Vaccine Institute; BioCubaFarma; National Fund for Science and Technology)
Conflict of interest: Yes

Methods
RCT
Location : Single center / Cuba
Follow-up duration (months): 1
2 doses of SOBERANA 02 (FINLAY-FR-2-25 mcg) + 1 dose SOBERANA Plus (FINLAY-FR-1-50 mcg) (n = 58)
3 doses of SOBERANA 02 (FINLAY-FR-2-25 mcg)(n = 55)
Inclusion criteria
  • Healthy persons according to clinical and laboratory criteria
  • aged 19–59 years (phase I) or 19–80 years (phase IIa)
  • of both sexes. The health condition was assessed during the screening visit, based on medical records, physical examination, and clinical and microbiological laboratory tests.
Exclusion criteria
  • History of SARS CoV-2 infection
  • acute diseases
  • congenital or acquired immunodeficiencies
  • personal history of liver or kidney failure
  • immunological treatment in the last three months
  • allergy to ingredients in the formulation
  • pregnancy, puerperium or breastfeeding.
Interventions
Intervention
2 IM doses of 25 mcg and 1 IM dose of 50 mcg, all 28 days apart
Control
3 IM doses of 25 mcg, all 28 days apart
Participants
Randomized
113 participants
Characteristics of participants
Type of participants: Healthy adults
N=113
0 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 19-74
Description of participants
Healthy adults with no known or suspected history of COVID-19 at a single center in Cuba.
Primary outcome
In the register
Phase 1 and 2a - Serious Adverse Events, Measurement time: daily for 28 days after each dose.
In the report
Occurrence of serious AEs measured daily during 28 days after each dose.
Documents
available

Protocol

NR

Statistical plan

*

Data-sharing stated: Yes, After publication in specialized journals.
Data accessibility: All data produced in the present study are available upon reasonable request to the authors https://www.finlay.edu.cu/blog/category/sala-cientifica/ Proposals should be sent to: dagarcia@finlay.edu.cu or: vicente.verez@finlay.edu.cu. These proposals must be reviewed and approved by the sponsor and investigator. Finally, data access agreement must be signed.
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 registries 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 reflects that in the registry. The Phase 1 and Phase 2a trials both achieved their target sample sizes.
This trial was updated on November 30th 2022 after publication of the study report.