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:
A Phase II, sequential, multicenter, adaptive, parallel groups, randomized, placebo-controlled, double-blinded, to evaluate safety, reactogenicity and immunogenicity of the prophylactic vaccine candidate FINLAY-FR-1A anti SARS-CoV-2, in COVID-19 convalescents. (COVID-19)
Acronym of Scientific Title:
Secondary indentifying numbers:
Issuing authority of the secondary identifying numbers:
Finlay Vaccine Institute (FVI)
Source(s) of monetary or material support:
Finlay Vaccine Institute. "Fondo de Ciencia e Innovacion" (FONCI) of Cuba’s Ministry of Science, Technology and the Environment
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 grade specialist in Integral General Medicine and Immunology
Affiliation:
Institute of Hematology and Immunology
Postal address:
8 street /17 and 19. Vedado, Plaza de la Revolucion
Telephone:
+53-78461146
+53-78305553
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, Cuban National Center for Sex Education (CENESEX), Yenisey Triana Marrero, MD First grade specialist in Integral general medicine and Immunology.
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):
Phase IIa:
Experimental group: FINLAY-FR-1A 50 μg of RBD + adjuvant, 0.5 mL by intramuscular route. Treatment scheme: one dose. Presentation: Vial with single dose.
Phase IIb:
Experimental group: FINLAY-FR-1A 50 μg of RBD + adjuvant, 0.5 mL by intramuscular route. Treatment scheme: one dose. Presentation: Vial with single dose.
Control group: Placebo group: Placebo with adyuvant, 0.5 mL by intramuscular route. Treatment scheme: one dose. Presentation: Vial with single dose.
Intervention code:
Post-Exposure Prophylaxis
Immunogenicity, Vaccine
Immunotherapy, Active
Vaccination
Injections, Intramuscular
Placebos
Single Dose
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 related to the vaccine-SAE (It will measure as: -Occurrence of the SAE (Yes, No); -Description of the AE (Name of the event); Duration (Time from start date until end date of 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 dose.
2. Satisfactory Immune Response-SIR (Inhibitory titer 50 (IT50) ≥ 250). Measurement time: Phase IIa: pre-vaccination and at 14 and 28 days post-vaccination. Phase IIb: pre-vaccination and 28 days post-vaccination.
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 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 dose.
3. Seroconversion (post-vaccination antibody concentration/baseline concentration ≥4). Measurement time: Phase IIa: 14 and 28 days post-vaccination. Phase IIb: 28 days post-vaccination.
4. Proportion of subjects with IgG inhibitory antibodies of RBD:hACE2 >70%. Measurement time: Phase IIa: pre-vaccination and at 14 and 28 days post-vaccination. Phase IIb: pre-vaccination and 28 days post-vaccination.
5. Proportion of subjects with virus neutralization titers. Measurement time: Phase IIa: pre-vaccination and at 14 days post-vaccination. Phase IIb: pre-vaccination and 28 days post-vaccination.
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 written informed consent to participate in the study.
2. Subjects aged between 19 and 80 years.
3. Body mass index between 18.5 and 34.9 kg/m2 (obese persons grade I will be included).
Exclusion criteria:
1. Subjects with a history of COVID-19 who meet any of the following criteria:
a) Current history of infection or having received a medical discharge for SARS-CoV 2 during the 2 months prior to recruitment.
b) History of severe clinical picture due to COVID-19, according to the medical history or obtained during the medical interview.
2. 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.
3. Subjects with antimicrobial treatment or sustained treatment with NSAIDs in the 7 days prior to the administration of the vaccine.
4. Subjects with chronic non-communicable diseases that are NOT controlled, according to clinical or laboratory criteria established for each entity in the Cuban medical standards (Ex: bronchial asthma, chronic obstructive pulmonary disease, ischemic heart disease, arterial hypertension, diabetes mellitus, thyroid diseases, neurological and hemolymphopoietic diseases, liver failure, kidney failure, psychiatric illness at a psychotic level, among others).
5. Subjects with congenital or current acquired immune system disease.
6. Subjects with a history of neoplastic disease without full remission.
7. Subjects with a history of substance abuse in the past 30 days or substance addictive illness, except 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.
11. Participation in another clinical trial of preventive or therapeutic intervention in the last 3 months.
12. Application of another vaccine in the last 30 days.
13. Treatment with immunomodulators in the last 30 days, eg; steroids (except for the occasional use of topical or inhaled steroids), cytostatics, interferon, immunoferon, transfer factor, monoclonal antibodies, biomodulin T, any ganmaglobulin, levamisole, heberferon, thymosin) or those who, due to their underlying disease, require treatment immunomodulator, which may coincide during the development of the study.
14. History of having received a blood transfusion or blood products in the last 3 months.
15. Subjects with difficulties in attending the planned follow-up consultations.
16. Splenectomy or splenic dysfunction.
17. Women of childbearing potential use safe contraceptive methods during the study.
18. Pregnancy, puerperium or lactation.
19. Subjects with tattoos in the deltoid region of both arms.
20. Subjects with positive results for: antibodies against HIV1 + 2, antibodies against hepatitis C, surface antigen of the hepatitis B virus and VDRL serology.
Study design Section to complete information about the characteristics of the study design.
Allocation:
Randomized controlled trial
Target sample size:
450 (Phase IIa 20, Phase IIb 430)
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
Specialty:
PhD in Biological Sciences
Postal Address:
21 Street / 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:
Second grade specialist in Immunology
Postal Address:
21 Street / 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: ochoa@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/soberana-plus-convalecientes/
Research Ethics Committees Section to complete the data related to the review ethics committees.
Name of Research Ethics Committees:
Institute of Hematology and Immunology
Status of evaluation date of Ethic Committee:
Postal address of Ethic Committee :
8 street bt. 17 and 19, Vedado. Havana. ZC 10400. Cuba
Telephone:
+53-78461101, +53-78305555
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:
