COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000366-En

Yanet Climent Ruiz

ycliment@finlay.edu.cu

2021-04-09

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

1. Subjects who give their written informed consent to participate in the study. 2. Subjects aged between 19 and 80 years. 3. Body mass index between 18.5 and 34.9 kg/m2 (obese persons grade I will be included).

1. Subjects with a history of COVID-19 who meet any of the following criteria: a) Current history of infection or having received a medical discharge for SARS-CoV 2 during the 2 months prior to recruitment. b) History of severe clinical picture due to COVID-19, according to the medical history or obtained during the medical interview. 2. 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. 3. Subjects with antimicrobial treatment or sustained treatment with NSAIDs in the 7 days prior to the administration of the vaccine. 4. Subjects with chronic non-communicable diseases that are NOT controlled, according to clinical or laboratory criteria established for each entity in the Cuban medical standards (Ex: bronchial asthma, chronic obstructive pulmonary disease, ischemic heart disease, arterial hypertension, diabetes mellitus, thyroid diseases, neurological and hemolymphopoietic diseases, liver failure, kidney failure, psychiatric illness at a psychotic level, among others). 5. Subjects with congenital or current acquired immune system disease. 6. Subjects with a history of neoplastic disease without full remission. 7. Subjects with a history of substance abuse in the past 30 days or substance addictive illness, except 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. 11. Participation in another clinical trial of preventive or therapeutic intervention in the last 3 months. 12. Application of another vaccine in the last 30 days. 13. Treatment with immunomodulators in the last 30 days, eg, steroids (except for the occasional use of topical or inhaled steroids), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibodies, biomodulin T, any ganmaglobulin, levamisole, heberferon, thymosin) or those who, due to their underlying disease, require treatment immunomodulator, which may coincide during the development of the study. 14. History of having received a blood transfusion or blood products in the last 3 months. 15. Subjects with difficulties in attending the planned follow-up consultations. 16. Splenectomy or splenic dysfunction. 17. Women of childbearing potential use safe contraceptive methods during the study. 18. Pregnancy, puerperium or lactation. 19. Subjects with tattoos in the deltoid region of both arms. 20. Subjects with positive results for: antibodies against HIV1 + 2, antibodies against hepatitis C, surface antigen of the hepatitis B virus and VDRL serology.

2

Finlay Vaccine Institute (FVI)

19

80

Cuba

Healthy volunteers

N/A

450

1. Serious Adverse Events related to the vaccine-SAE (It will measure as: -Occurrence of the SAE (Yes; No); -Description of the AE (Name of the event); Duration (Time from start date until end date of 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 dose. 2. Satisfactory Immune Response-SIR (Inhibitory titer 50 (IT50) = 250). Measurement time: Phase IIa: pre-vaccination and at 14 and 28 days post-vaccination. Phase IIb: pre-vaccination and 28 days post-vaccination.

Phase 2

[{"arm_notes": "50 \u03bcg;1", "treatment_id": 513, "treatment_name": "Finlay-fr-1a anti-sars-cov-2 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]