COVID-19 COVID-19 SARS-CoV2
Conditions
Interventions
Group 1: CIGB-669 (50 µg RBD + 40 µg AgnHB)
In each administration (nasal spray) the dose of the product is 200 µL (100 µL for each nostril) corresponding to 50 µg of receptor-binding domain (RBD) recombinant protein and 40 µg of nucleocapsid a
short scheme: 0 (nasal) - 14 (nasal) - 28 (nasal) days.
Group 2: CIGB-669 (RBD 50 µg + AgnHB 40 µg) intranasally (nasal spray) 200 µL (100 µL for each nostril)
long scheme: 0 (nasal) - 28 (nasal) - 56 (nasal) days.
Group 3: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg)
0.5 mL intramuscularly in the deltoid region in the 1st dose, followed by another two doses with CIGB-669 (RBD 50 µg + AgnHB 40 µg) intranasally (nasal spray) 200 µL (100 µL for each nostril)
short scheme: 0 (intramuscular) - 14 (nasal) - 28 (nasal) days.
Group 4: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg)
long scheme: 0 (intramuscular) - 28 (nasal) - 56 (nasal) days.
These interventions will be carried out during the first stage (phase I). Subsequently, an intermediate analysis will be carried out wher
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Injections, Intramuscular
Administration, Intranasal
CIGB-669, CIGB-66
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB), in Havana
Eligibility
Sex/Gender
All
Age
19 Years to 54 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Specific anti-RBD IgG antibodies (geometric mean). Measurement time: on days 0, 14, 28 and 42 (for the short vaccination schedule: 0-14-28) and 0, 14, 28, 42, 56 and 70 (for the long schedule: 0-28- 56). 2. ACE2 inhibition (by ELISA - Enzyme-linked immunoadsorption assay). Measurement time: on days 0, 28 and 42 (for the short vaccination scheme) and 0, 28, 56 and 70 (for the long scheme). 3. Humoral response of specific anti-RBD IgM antibodies. Measurement time: on days 0, 28 and 42 (for the short vaccination scheme) and 0, 28, 56 and 70 (for the long scheme). 4. Humoral and mucosal response of anti-RBD Antibodies (IgA). Measurement time: at screening and at day 42 for short schedules and at screening and at day 70 for long vaccination schedules for mucosal response. The baseline value in the case of humoral IgA would be t = 0. | — |
Countries
Cuba
Contacts
Public ContactZurina Cinza Estevez
Center for Genetic Engineering and Biotechnology (CIGB).
Outcome results
None listed