General information Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Scientific title:
Phase I study, open, sequential and adaptive for evaluating the safety, reactogenicity and explore the immunogenicity of the prophylactic Vaccine Candidate FINLAY-FR-2 anti SARS-CoV-2 (COVID-19)
Acronym of Scientific Title:
Secondary indentifying numbers:
Issuing authority of the secondary identifying numbers:
Finlay Vaccine Institute (IFV)
Source(s) of monetary or material support:
Finlay Vaccine Institute; Cuban Fund for Science and Innovation (FONCI) from Ministry of Science, Technology and EnviromentCITMA
Authorization for beginning Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Center for State Control of Drugs, Medical Devices and Equipment (CECMED)
Principal investigator Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
Medical Specialty :
First degree specialist in Integral General Medicine. Doctor of Medical Science
Affiliation:
Institute of Tropical Medicine "Pedro Kouri"
Postal address:
Novia del Mediodia avenue, KM 6 1/2, La Lisa
Clinical sites to participate Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Clinical sites:
Havana, Clinica 1 La Lisa, Leslyhana Verdecia Sanchez, MD. Specialist in Internal Medicine
Recruitment status Section to complete information about the recruitment status and the date of first enrolment subject
Date of first enrollment:
Health condition and Intervention Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Health condition(s) code:
Disease Prevention
Coronavirus Infections
SARS Virus
Coronaviridae Infections
Betacoronavirus
Health condition keyword:
Intervention(s):
Group 1- FINLAY-FR-2 (Experimental): Low dose conjugated RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose. Booster dose 45-60 days after 2nd Doses: 10 subjects with FINLAY-FR-2 (Experimental): low dose of conjugated RBD+adjuvant; 0,5 mL, intramuscular (IM) and 10 subjects with FINLAY-FR-1A 50 ug dRBD/alumina, 0,5 mL,intramuscular (IM)
Group 2- FINLAY-FR-2 (Experimental): High dose conjugated RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose. Booster dose 45-60 days after 2nd Doses: 10 subjects with FINLAY-FR-2 (Experimental): high dose of conjugated RBD+adjuvant; 0,5 mL, intramuscular (IM) and 10 subjects with FINLAY-FR-1A 50 ug dRBD/alumina, 0,5 mL,intramuscular (IM)
Intervention code:
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Injections, Intramuscular
Outcomes and Timepoint Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
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.
Key secondary outcomes:
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 to pre-vaccination). Measurement time: Day 28, 42 and 56.
4) Neutralizing antibody titer: Measurement time: Day 0 and 56.
5) % ACE2-RBD inhibition: Measurement time: Day 0, 28, 42 and 56.
Selection criterias Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Inclusion criteria:
1. Subjects who give their informed consent to participate in the study in writing.
2. Subjects aged between 19 and 59 years.
3. Women of childbearing potential use safe contraceptive methods during the study.
4. General, regional and apparatus physical examination: normal or without clinically significant alterations.
5. 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 Weight Loss (BMI <18.5) and Obesity (BMI ≥ 30.0)
4. Subjects with chronic non-communicable diseases not controlled according to clinical or laboratory criteria (eg bronchial asthma, chronic obstructive pulmonary disease, diabetes mellitus, thyroid diseases, ischemic heart disease, arterial hypertension, psychiatric, neurological, hemolymphopoietic system disease ).
5. Subjects with congenital or acquired immune system disease.
6. Subjects with a history of unresolved neoplastic disease.
7. Subjects with a personal history of liver or kidney failure.
8. Subjects with a history of substance abuse within the past 30 days or substance addictive illness, except withdrawal and smoking.
9. Subjects with diminished mental faculties for decision making.
10. Subjects with a history of severe allergic disease (anaphylactic shock, angioneurotic edema, glottis edema, severe urticaria).
11. Subjects with a history of hypersensitivity to thiomersal or to some of the components of the formulation.
12. Subjects with a history of SARS 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 positive test for Anti-SARS-CoV-2 Antibodies.
d) Subject with positive PCR at the time of inclusion.
13. Participation in another clinical trial in the last 3 months.
14. Application of vaccines containing tetanus toxoid in the last 3 months.
15. Application of other vaccines in the last 30 days.
16. Treatment with immunomodulators in the last 30 days, considering steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibody, Biomodulin T, any ganmaglobulin, Levamisole, Heberferon, thymosin) or other drugs with action immunomodulatory. In addition, those people who, due to their underlying disease, require immunomodulatory treatment during the development of the study.
17. Transfusion of blood or blood products in the last 3 months.
18. Subjects with difficulties in attending the planned follow-up consultations.
19. Splenectomy or splenic dysfunction.
20. Pregnancy, puerperium or lactation.
21. Subjects with tattoos in the deltoid region on both arms.
22. Subjects with positive results for HIV, Hepatitis B surface antigen, Hepatitis C Antibody, and VDRL serology.
Study design Section to complete information about the characteristics of the study design.
Allocation:
Non-randomized controlled trial
Contact for public queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
Postal Address:
21 avenue bw/ 198 and 200 Atabey, Playa
Contact for scientific queries Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
Specialty:
First degree specialist in Integral General Medicine. Master in Epidemiology
Postal Address:
21 avenue bw/ 198 and 200 Atabey, Playa
Data Sharing Section to complete the data related to the data sharing plan.
Description of Data Sharing Plan:
The immunological individual data, and other supporting clinical documents, including study protocol, statistical analysis plan, and the informed consent form will be available after publication in specialized journals. Proposals should be sent to: dagarcia@finlay.edu.cu or: vicente.verez@finlay.edu.cu. These proposals must be reviewed and approved by the sponsor and investigator. Finally, data access agreement must be signed.
Additional information to share:
The Study protocol, statistical analysis plan, and the informed consent form will be available after publication.
URL for additional information:
https://www.finlay.edu.cu/blog/category/sala-cientifica/
Research Ethics Committees Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
National Toxicology Center (CENATOX)
Status of evaluation date of Ethic Committee:
Postal address of Ethic Committee :
Avenida 31 y 114, Marianao, Havana, ZC: 11500, Cuba
About study completion Section to complete the data related to the study completion.
Date of available results:
Date of first publication:
Registration and Update Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Date of Registration in Primary Registry:
Record Verification Date:
Link to the spanish version:
