Covid-19 Living Data

Trial RPCEC00000338
Publication Pérez-Rodríguez S, Vaccine, 2022
Dates: 2020-10-19 to 2020-10-24
Funding: Public/non profit (Finlay Vaccine Institute; Cuban Fund for Science and Innovation (FONCI) from Ministry of Science, Technology and Environment)
Conflict of interest: Yes

Methods
	RCT
	Location : Single center / Cuba Follow-up duration (months): 4.3
	FINLAY-FR-1A-25 (n = 20) FINLAY-FR-1 (n = 20) FINLAY-FR-1A-50 (n = 20)
Inclusion criteria	1. Subjects who give their informed consent to participate in the study by writing 2. Subjects aged between 19 and 59 years 3. Body mass index between 18.5 and 29.9 kg / m2 4. Women of childbearing potential use safe contraceptive methods during the study 5. General, regional and apparatus physical examination: normal or without clinically significant alterations 6. Laboratory results within or outside the range of reference values but not clinically significant
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 antimicrobial treatment in the 7 days prior to the administration of the vaccine 3. Subjects with chronic non-communicable diseases not controlled according to clinical or laboratory criteria (bronchial asthma, chronic obstructive pulmonary disease, ischemic heart disease, arterial hypertension, diabetes mellitus, thyroid, neurological, hemolymphopoietic system diseases, psychiatric disease at a psychotic level) 4. Subjects with congenital or acquired immune system disease 5. Subjects with a history of unresolved neoplastic disease 6. Subjects with a personal history of liver or kidney failure 7. Subjects with a history of abuse of toxic substances during the last 30 days or addictive illness to toxic substances, except if the subject is in abstinence, in the case of alcoholics and smoking 8. Subjects with diminished mental faculties 9. Subjects with a history of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria) 10. Subjects with a history of hypersensitivity to thiomersal or to some of the components of the formulation 11. Subjects with a history of SARS-CoV 2 and COVID-19 who meet any of the following criteria: a) Previous or current history of SARS-CoV 2 infection. b) Be declared in the category of contact or suspect at the time of inclusion. c) Subject with specific antibodies to SARS-CoV 2. d) Patient with PCR positive for SARS-CoV 2 12. Participation in another clinical trial in the last 3 months 13. Application of another vaccine in the last 30 days 14. Application of the VA-MENGOC-BC vaccine in the last 3 months 15. Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Levamisole, Heberferon, Thymosin) or predictably those people that due to their underlying disease require immunomodulatory treatment, which may coincide during the development of the study 16. Transfusion of blood or blood products in the last 3 months 17. Subjects with difficulties in attending the planned follow-up consultations 18. Splenectomy or splenic dysfunction 19. Pregnancy, puerperium or lactation 20. Subjects with tattoos in the deltoid region on both arms 21. Subjects positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or syphilis specific antibody.
Interventions
	Intervention 3 IM doses of 25 mcg d-RBD in aluminium hydroxide gel on days 0, 28 and 56 3 IM doses of 50 mcg d-RBD in aluminium hydroxide gel on days 0, 28 and 93-101
	Control 3 IM doses of 50 mcg d-RBD and outer membrane vesicles of Neisseria meningitidis in aluminium hydroxide gel on days 0, 28 and 93-101 (3rd dose 50 mcg d-RBD with or without membrane vesicles of Neisseria meningitidis)
Participants
	Randomized 60 participants
	Characteristics of participants Type of participants: Adults N=60 28 males Children: 0 Pregnant women: 0 Immunocompromized patients: 0 Mean age: Age range: 20-57
	Description of participants Adults, age 19-59, with no history of previous SARS-CoV-2 infection at a single center in Cuba.
Primary outcome
	In the register Serious Adverse Events-SAE (It will measure as: -Occurrence of the SAE (Yes, No), - Duration (Time from start date until end date of event), -Description of the event, Result (Recovered, Recovered with squeals, Persists, Death, Unknown), - Causality (Causal association consistent with vaccination, Undetermined, Inconsistent causal association with vaccination, not classifiable). Measurement time: daily for 28 days after each dose.
	In the report The two co-primary outcomes, safety and reactogenicity, were assessed until 28 days after the third, last dose. Safety was measured by the occurrence of serious adverse events. Results of laboratory analyses on blood samples at 28 days after the last dose were compared to pre-vaccination values.
Documents available	Protocol NR Statistical plan * Data-sharing stated: Yes, After publication Data accessibility: Supporting clinical data and documents, including immunological individual data, will be available after publication of this article through direct request to: ochoa@finlay.edu.cu or: vicente.verez@finlay.edu.cu.
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	Low
General comment	In addition to the pre-print article, the trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The primary outcomes in the article (safety and reactogenicity) differed from the primary outcome in the registry (serious adverse events). Long term follow up continues. This trial was updated on Mars 10th, 2022 after publication of the study report.