COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000332-En

Beatriz Paredes Moreno

bparedes@finlay.edu.cu

2020-08-13

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Subjects who give written informed consent to participate in the study.2. Subjects aged between 19-59 and 60-80 years.3. Body mass index between 18 and 29.9 kg / m2.4. Women of childbearing potential using safe contraceptive methods during the study.5. General, regional and apparatus physical examination: normal or without clinically significant alterations.6. Clinical Laboratory testing within the range of reference values, or outside ??but not clinically significant (Only for Phase I)

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 treated with antimicrobials or NSAIDs in the 7 days prior to the administration of the vaccine. 3. Subjects with non-trasmisible chronic 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 substance abuse in the past 30 days or substance addictive illness, except withdrawal. 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 other component of the formulation. 11. Subjects with a history of SARS 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 positive rapid test for SARS-CoV 2. d) Patient with a positive PCR at the time of inclusion. 12. Participation in another clinical trial in the last 3 months. 13. Application of another vaccine in the last 30 days. 14. Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibody, Biomodulin T, any gammaglobulin, Levamisole, Heberferon, thymosin) or predictably those people that due to their underlying disease could require immunomodulatory treatment during the study. 15. Transfusion of blood or blood products in the last 3 months for phase I and last 30 days for phase II. 16. Patients with difficulties in attending planned follow-up visits. 17. Splenectomy or splenic dysfunction. 18. Pregnancy, puerperium or lactation.

2

Finlay Vaccine Institute (IFV)

19

80

Cuba

Healthy volunteers

N/A

676

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. 2) Titer of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time At baseline and; 14; 28 and; 56 days.

Phase 1/Phase 2

[{"arm_notes": "1", "treatment_id": 781, "treatment_name": "Meningococcal vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "1", "treatment_id": 514, "treatment_name": "Finlay-fr-1 anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]