SOBERANA 01A

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000338
• Date of registration: 17/10/2020
• Prospective Registration: Yes
• Primary sponsor: Finlay Vaccine Institute (IFV)
• Public title: SOBERANA 01A
• Scientific title: Phase I, randomized, double-blind and adaptive study to evaluate the safety, reactogenicity and explore the immunogenicity of different formulations of the Prophylactic Vaccine Candidates against SARS - CoV - 2, FINLAY- FR-1 and FINLAY- FR-1A (COVID-19). - SOBERANA 01A
• Date of first enrolment: 19/10/2020
• Target sample size: 60
• Recruitment status: Complete
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000338-En
• Study type: Interventional
• Study design: Allocation: Randomized trial. Masking: Double Blind. Control group: Uncontrolled. Assignment: Parallel. Purpose: Prevention
• Phase: 1

Countries of recruitment

Cuba

Contacts

• Name: Meiby de la Caridad Rodriguez Gonzalez
• Affiliation: Finlay Vaccine Institute

• Name: Beatriz Paredes Moreno
• Affiliation: Finlay Vaccine Institute

Key inclusion & exclusion criteria

Inclusion criteria: 1. Subjects who give their informed consent to participate in the study by writing.
2. Subjects aged between 19 and 59 years.
3. Body mass index between 18.5 and 29.9 kg / m2.
4. Women of childbearing potential use safe contraceptive methods during the study.
5. General, regional and apparatus physical examination: normal or without clinically significant alterations.
6. Laboratory results within or outside the range of reference values ??but not clinically significant
Exclusion criteria: 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 with antimicrobial treatment in the 7 days prior to the administration of the vaccine.
3. Subjects with chronic non-communicable 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 abuse of toxic substances during the last 30 days or addictive illness to toxic substances, except if the subject is in abstinence, in the case of alcoholics and 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 or to some of the components of the formulation.
11. Subjects with a history of SARS-CoV 2 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 specific antibodies to SARS-CoV 2.
d) Patient with PCR positive for SARS-CoV 2.
12. Participation in another clinical trial in the last 3 months.
13. Application of another vaccine in the last 30 days.
14. Application of the VA-MENGOC-BC vaccine in the last 3 months.
15. Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Levamisole, Heberferon, Thymosin) or predictably those people that due to their underlying disease require immunomodulatory treatment, which may coincide during the development of the study.
16. Transfusion of blood or blood products in the last 3 months.
17. Subjects with difficulties in attending the planned follow-up consultations.
18. Splenectomy or splenic dysfunction.
19. Pregnancy, puerperium or lactation.
20. Subjects with tattoos in the deltoid region on both arms.
21. Subjects positive for hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or syphilis specific antibody.

Age minimum: 19 years
Age maximum: 59 years
Gender: Male/Female

Health Condition(s) or Problem(s) studied

Betacoronavirus

Disease Prevention

Coronavirus Infections

Prevention of COVID-19 disease
COVID-19
SARS-CoV2

SARS-CoV2

Coronaviridae Infections

COVID-19

SARS Virus

Intervention(s)

Group 1- FINLAY-FR-1 (Experimental): High dose of RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. A 3rd booster dose between 2 and 4 months after the second dose.This group will be subdivided in two subgroups: one will be boosted with the same vaccine (homologous schedule) or with FINLAY-FR-1A (high dose) (heterologous schedule). Presentation: Vial with single dose.
Group 2- FINLAY-FR-1A (Experimental): High dose of RBD+adjuvant A; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. A 3rd booster dose between 2 and 4 months after the second dose. Presentation: Vial with single dose.
Group 3- FINLAY-FR-1A (Experimental): Low dose of RBD+adjuvant A; 0.5 mL by intramuscular route. Treatment scheme: 0-28-56 days. Presentation: Vial with single dose.

Immunogenicity, Vaccine

Immunotherapy, Active

Vaccination

Injections, Intramuscular

Meningococcal Vaccines

Primary Outcome(s)

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.

Secondary Outcome(s)

1) Solicited Local and systemic Adverse Events (AE) (They will measure as: -Occurrence of the AE (Yes, No), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious), -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causation (causal association consistent with vaccination, Indeterminate, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 7 days after each dose.
2) Unsolicited Adverse Events (AE) (They will measure as: Description of the AE (name of the event), Duration (Time from start date until end date of event), -Intensity of the AE (mild, moderate, severe), -Severe (Serious, not serious) , -Result (Recovered, Recovered with sequelae, Persists, Death, Unknown), -Causality (causal association consistent with vaccination, Undetermined, causal association inconsistent with vaccination, not classifiable)). Measurement time: daily for 28 days after each dose .
3) Titer of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time: Day 28, 42 and 56 for all groups and, day 84 for group 3, and 28 days after the booster dose for groups 1 y 2.
4) Neutralizing antibody titer: Measurement time: Day 0 and 56 for all groups and, day 84 for group 3, and 28 days after the booster dose for groups 1 y 2.
5)% ACE2-RBD inhibition: Measurement time: Day 0, 28, 42 and 56 for all groups and, day 84 for group 3, and 28 days after the booster dose for groups 1 y 2.

Secondary ID(s)

IFV/COR/05

Source(s) of Monetary Support

Finlay Vaccine Institute; Cuban Fund for Science and Innovation (FONCI) from Ministry of Science, Technology and Enviroment

Secondary Sponsor(s)

Not applicable

Ethics review

Status: Approved
Approval date: 12/10/2020
Contact:

[e-mail]

National Toxicology Center (CENATOX)

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 15/02/2021
• Date Completed: 15/02/2021