Revisions for SOBERANA PLUS | Registro Público Cubano de Ensayos Clínicos

Comparing two revisions:

--- 9 April 2021 - 8:03pm by Gladys
+++ 19 November 2021 - 9:22pm by FINLAY
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Revision of 19 November 2021 - 9:22pm:

SOBERANA PLUS

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.

Acronym of Public Title:

SOBERANA PLUS

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:

SOBERANA PLUS

Secondary indentifying numbers:

IFV/COR/11

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)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Arturo

Last name:

Chang Monteagudo

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

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78461146

+53-78305553

Email address:

achangm@gmail.com

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:

Cuba

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

Recruitment status:

Pending

Date of first enrollment:

17/04/2021

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:

COVID-19

Health condition(s) code:

Disease Prevention

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

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.

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

80 years

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.

Type of population:

Adults

Type of participant:

Healthy volunteers

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Prevention

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

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

First Name:

Yanet

Last Name:

Climent Ruiz

Specialty:

PhD in Biological Sciences

Affiliation:

Finlay Vaccine Institute

Postal Address:

21 Street / 198 and 200, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72719123

Email :

ycliment@finlay.edu.cu

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.

First Name:

Rolando

Middle Name:

Felipe

Last Name:

Ochoa Azze

Specialty:

Second grade specialist in Immunology

Affiliation:

Finlay Vaccine Institute

Postal Address:

21 Street / 198 and 200, Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+53-72719123

Email :

ochoa@finlay.edu.cu

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:

Approved

Status of evaluation date of Ethic Committee:

29/03/2021

Postal address of Ethic Committee :

8 street bt. 17 and 19, Vedado. Havana. ZC 10400. Cuba

Telephone:

+53-78461101, +53-78305555

Email:

vmarsan@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

14/06/2021

Date of available results:

12/07/2021

Date of first publication:

23/08/2021

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).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000366

Date of Registration in Primary Registry:

09/04/2021

Record Verification Date:

2021/11/19

Next update date:

2022/11/19

Link to the spanish version:

Click here

Registered Trials

Registration process

SOBERANA PLUS

About the RPCEC

Useful resources