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 / II, randomized, controlled, adaptive, double-blind and multicenter study to evaluate the safety, reactogenicity and immunogenicity, of the prophylactic FINLAY-FR-1 anti-SARS-CoV-2 Vaccine Candidate in a two-doses schedule. (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 Enviroment
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 Internal Medicine
Affiliation:
National Toxicology Center (CENATOX)
Postal address:
Avenue. 31 and 114 street. Marianao
Telephone:
+53-72603252
+53-72601230
+53-72608751
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:
Centro Nacional de Toxicología. Central Army Hospital “Dr. Carlos J. Finlay”, “Carlos J. Finlay” Order. Principal Investigator Dr. Sonia Pérez Rodríguez
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:
Prevention of COVID-19 disease
Health condition(s) code:
Coronavirus Infections
SARS Virus
Coronaviridae Infections
Betacoronavirus
Health condition keyword:
Intervention(s):
FINLAY-FR-1 intervention (Experimental): Dose 10 µg of RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.
FINLAY-FR-1 intervention (Experimental): Dose 20 µg of RBD+adjuvant; 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.
VA-MENGOC-BC® intervention (Control): Dose of 0.5 mL by intramuscular route. Treatment scheme: 0-28 days. Presentation: Vial with single dose.
In each intervention will be two age groups: 19-59 years and 60-80 years.
Intervention code:
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Injections, Intramuscular
Meningococcal Vaccines
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.
2) Titer of specific anti-RBD IgG antibodies (Percentage of subjects with seroconversion 4 fold). Measurement time At baseline and, 14, 28 and, 56 days.
Key secondary outcomes:
1) Solicited Local and systemic Adverse Events measured as: -Occurrence of the Adverse Event (Yes, No), Duration (Time from start date until end date of event), -Intensity of the Adverse Event (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 measured as: Description of the Adverse Event (name of the event), Duration (Time from start date until end date of event), -Intensity of the Adverse Event (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) Neutralizing antibody titer, measurement time: At baseline and, 56 days.
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 written informed consent to participate in the study.
2. Subjects aged between 19-59 and 60-80 years.
3. Body mass index between 18 and 29.9 kg / m2.
4. Women of childbearing potential using safe contraceptive methods during the study.
5. General, regional and apparatus physical examination: normal or without clinically significant alterations.
6. Clinical Laboratory testing within the range of reference values, or outside but not clinically significant (Only for Phase I)
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 treated with antimicrobials or NSAIDs in the 7 days prior to the administration of the vaccine.
3. Subjects with non-trasmisible chronic 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 substance abuse in the past 30 days or substance addictive illness, except withdrawal.
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 other component of the formulation.
11. 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 rapid test for SARS-CoV 2.
d) Patient with a positive PCR at the time of inclusion.
12. Participation in another clinical trial in the last 3 months.
13. Application of another vaccine in the last 30 days.
14. Treatment with immunomodulators in the last 30 days (eg steroids (except topical and inhaled), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibody, Biomodulin T, any gammaglobulin, Levamisole, Heberferon, thymosin) or predictably those people that due to their underlying disease could require immunomodulatory treatment during the study.
15. Transfusion of blood or blood products in the last 3 months for phase I and last 30 days for phase II.
16. Patients with difficulties in attending planned follow-up visits.
17. Splenectomy or splenic dysfunction.
18. Pregnancy, puerperium or lactation.
Study design Section to complete information about the characteristics of the study design.
Allocation:
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:
Ffirst degree specialist in Comprehensive 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.
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 :
Ave. 31 and 114 street. Apdo. 14020 Marianao. Havana. Cuba
About study completion Section to complete the data related to the study completion.
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:
