COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000338-En

Beatriz Paredes Moreno

bparedes@finlay.edu.cu

2020-10-17

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

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

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.

3

Finlay Vaccine Institute (IFV)

19

59

Cuba

Healthy volunteers

N/A

60

1) 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.

Phase 1

[{"arm_notes": "High dose; 0.5 mL;2 (0-28 days);IM", "treatment_id": 514, "treatment_name": "Finlay-fr-1 anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Low dose; 0.5 mL;3 (0-28-56 days);IM", "treatment_id": 513, "treatment_name": "Finlay-fr-1a anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "High dose; 0.5 mL;2 (0-28 days);IM", "treatment_id": 513, "treatment_name": "Finlay-fr-1a anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]