COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000345-En

Zurina Cinza Estevez

zurina.cinza@cigb.edu.cu

2020-11-26

Not recruiting

RCT

Randomized

Parallel

Open label

unclear

Prevention

1) Women and men, 19 to 54 years of age (Phase I) and 19 to 80 years of age (Phase II). 2) Physical examination without clinically significant alterations. 3) Laboratory tests within or outside the reference range, but not clinically significant. 4) Willingness of the subject to participate expressed through the delivery of signed informed consent.

1) History of COVID-19 or current condition of COVID-19 +, confirmed by laboratory PCR and / or rapid test).2) Contact or suspect of COVID-19 at the time of inclusion.3) Presence of fever or cough or shortness of breath or anosmia / ageusia, or acute infection during the 15 days prior to the administration of the vaccine candidate or at the time of its application.4) Decompensated chronic diseases.5) Those who have been at high risk of exposure: close contacts of confirmed cases of SARS-CoV-2 infection, front-line healthcare professionals for COVID-19 patients working in the ER, ICU and other areas higher risk.6) Any finding or medical condition in the nostrils that makes it difficult to properly administer the product and follow-up (eg, chronic obstructive allergic rhinitis, obstructive nasal septum deviation, benign and malignant nostril tumors such as polyposis and squamous cell carcinoma).7) Tattoos in both deltoid regions that make it difficult to observe the injection site, taking into account the random nature of the allocation of treatment.8) Findings in laboratory tests outside the reference values ??and that are clinically significant.9) Obesity (BMI = 35 Kg / m2) or underweight (BMI =18 Kg / m2)10) Have previously received a licensed or investigational vaccine, specific for coronavirus.11) Use of any investigational product (drug or vaccine) within 3 months prior to recruitment, or planned for during the study period.12) Having been treated within the previous three months or the possibility of requiring treatment during the trial for any underlying condition with: immunomodulators (eg some type of Interferon, Transfer Factor, Biomodulin T, Immunoferon, Thymosin), or with steroids by any route of administration, or with cytostatics.13) Have received blood, immunoglobulins and / or any blood product within the three months prior to inclusion.14) Allergy to Thimerosal or any other component of the formulations under study (Allergy to Thimerosal in Phase II is not relevant if the group with CIGB 66 is not selected).15) History or suspicion of alcoholism or drug dependence.16) Pregnancy, breastfeeding or willingness to get pregnant during the study. Women of childbearing potential who do not agree to use effective contraception within 3 months after completing the third study dose.17) Presence of mental and / or psychiatric disorders that make it impossible to sign the informed consent or follow-up of the volunteer.

4

Center for Genetic Engineering and Biotechnology (CIGB); in Havana

19

54

Cuba

Healthy volunteers

N/A

88

1. Safety - Clinical Adverse Events-AE (They will be measured as: -Occurrence of AE (Yes; No); -Description of AE (name of event); -Intensity of AE (mild; moderate; severe); -Casuality relationship ( unrelated; doubtful; possible; probable; definitive); -Measures adopted (None; Administration of any pharmacological therapy; Addition of a non-pharmacological therapy; Study exit; Hospitalization / prolongation of hospitalization); -Result (Completely resolved; Resolved with sequelae; Conditions in improvement; Condition present and unchanged; Worsening; Death caused by this event)). Measurement time: within 28 days after the application of each dose.2. Proportion of subjects with seroconversion of anti-RBD IgG antibodies to SARS-CoV-2 (seroconversion will be considered as that = 4 times the initial determination of the antibody titer). Measurement time: on days 14; 28 and 42 (for the short scheme 0-14-28) and 14; 28; 56 and 70 (for the long scheme 0-28-56); with respect to the baseline time.

Phase 1/Phase 2

[{"arm_notes": "50 \u00b5g + 40 \u00b5g;3 (day0-14-28)", "treatment_id": 1976, "treatment_name": "Cigb-669", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "50 \u00b5g + 40 \u00b5g;3 (day0-28-56)", "treatment_id": 1976, "treatment_name": "Cigb-669", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "(50 mcg + 0.30mg)+2(50\u00b5g + 40\u00b5g);3 (day0-14-28)", "treatment_id": 1977, "treatment_name": "Cigb-66+cigb-669", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "(50 mcg + 0.30mg)+2(50 \u00b5g + 40 \u00b5g);3 (day0-28-56)", "treatment_id": 1977, "treatment_name": "Cigb-66+cigb-669", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]