COVID-19 Convalescence COVID-19 SARS-CoV2
Conditions
Interventions
Stage I
Group A: Vaccine candidate CIGB-669 (RBD 50 µg + 40 µg de HBcAg)/200 µL spray by nasal route, 1 shot in each nostril, single dose (Mambisa group).
Group B: Vaccine candidate CIGB-669 (RBD 50 µ
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Single Dose
Injections, Intramuscular
Administration, Intranasal
CIGB-669,
CIGB-66,
MAMBISA,
ABDALA
Sponsors
Center for Genetic Engineering and Biotechnology (CIGB)
Eligibility
Sex/Gender
All
Age
19 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged between 19 and 80 years, both inclusive. 2. Subjects convalescing from COVID-19 with at least 2 months of being discharged. 3. Subjects who express, in writing, their consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with a current confirmed history of COVID-19 +. 2. Subjects considered contacts or suspects of COVID-19 at the time of inclusion. 3. Subjects who report any of the following symptoms: - fever, - cough or shortness of breath, - loss of smell (anosmia), - loss of taste (ageusia) or - acute infection during the 15 days prior to inclusion 4. Subjects with decompensated chronic diseases at the time of inclusion. 5. Subjects with a finding or medical condition in the nostrils that makes it difficult to properly administer the product and follow-up (Example: chronic obstructive allergic rhinitis, obstructive nasal septum deviation, benign and malignant nasal tumors such as polyposis and squamous cell carcinoma). 6. Subjects with tattoos in both deltoid regions that make it difficult to see the injection site, taking into account the random nature of the treatment assignment. 7. Obese subjects (BMI = 35 Kg / m2) or underweight (BMI =18 Kg / m2). 8. Subjects who previously received treatment with a coronavirus-specific licensed or investigational vaccine. 9. Subjects who received treatment with any investigational product within 3 months prior to recruitment, or who anticipate their planning during the study period. 10. Subjects who received treatment with immunomodulators (Example: some type of Interferon, Transfer Factor, Biomodulin T, Immunoferon, Thymosin), steroids or cytostatics within the three months prior to recruitment or that may require it during the course of the study due to any condition of base. 11. Subjects who received treatment with blood, immunoglobulins and / or any blood product within the three months prior to enrollment. 12. Subjects with a history of allergy to Thiomersal or to any other component of the formulations under study. 13. Subjects with a history or suspicion of alcoholism or drug dependence. 14. Women who are pregnant, breastfeeding or willing to become pregnant during the study. 15. Women of childbearing potential who do not agree to use a contraceptive method during the study. 16. Subjects with mental and / or psychiatric disorders that prevent or limit the signing of the informed consent or the follow-up of the volunteer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.-Quantification of specific anti-RBD IgG antibody titers (AU / mL). Measurement time: at 14 days after the administration of the dose with respect to the baseline. 2.-Percentage (%) of inhibition of the binding of the RBD protein to the ACE2 receptor in serum. Measurement time: on days 14 and 28 after the administration of the dose, and every 28 days until the decrease in titers. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.- Quantification of specific anti-RBD IgA antibody titers (AU / mL) in saliva and nasal discharge. Measurement time: baseline and on days 14 y 28 after the administration of the dose, and only in stage 1, every 28 days until titers decline. 2.- Title of neutralization of SARS-CoV-2. Measurement time: on days 14 and 28 after the administration of the dose, and every 28 days until the decrease in titers. 3.- Percentage (%) of seroconversion. Measurement time: on days 14 and 28 after the administration of the dose and every 28 days until the decrease in titers. | — |
Countries
Cuba
Contacts
Public ContactYinet Barrese Perez
National Coordinating Center for Clinical Trials
Outcome results
None listed