VA-MENGOC-BC to stimulate the innate response against SARS-CoV-2

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:

VME-CORONA

Scientific title:

Population impact of intervention based on the administration of a single dose of the Outer Membrane Vesicle (OMV) complex contained in VA-MENGOC-BC to stimulate the innate response against SARS-CoV-2 (COVID-19)

Acronym of Scientific Title:

VME-CORONA

Secondary indentifying numbers:

VME-CORONA

Issuing authority of the secondary identifying numbers:

Finlay Vaccine Institute (IFV)

Source(s) of monetary or material support:

Ministry of Public Health (MINSAP) BIOCUBAFARMA

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)

Authorization date :

03/04/2020

Reference number:

In process

Principal investigator

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

First name:

Maria

Midle name:

Eugenia

Last name:

Toledo Romani

Medical Specialty :

Specialist of second degree in Epidemiology

Affiliation:

"Pedro Kouri" Tropical Medicine Institute (IPK)

Postal address:

Novia del Mediodia avenue, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53-72020425

+53-72553199

Email address:

mariaeugenia@ipk.sld.cu

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, Popular Councils of Plaza and Centro Habana Municipalities

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Recruiting

Date of first enrollment:

24/04/2020

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

Intervention(s):

Study Group: Intramuscular injection into the left deltoid region of a 0.5 ml dose of the VA-MENGOC-BC® Meningococcal Vaccine. Presentation of the vaccine: Vials with unitary dose Control group: No intervention

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):

EIndicators: No. of cases (suspected, confirmed, serious, critical, deceased) Unit of Measure: Proportional variation. Measurement time: weekly (statistical weeks until the end of the epidemic)

Key secondary outcomes:

1-Adverse local and systemic events (They will be measured as: -Ocurrence of AE (Yes, No), -Description of the EA (name of the event), -Intensity of the EA (mild, moderate, severe), -Relation of causality (no related, doubtful, possible, probable, definitive) -Measures taken (None, Administration of some pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), -Result (Fully resolved, Solved with sequelae, Conditions in improvement, Present and unchanged condition, Worsening, Death caused by this event). Measurement time: daily for 7 days on an outpatient basis. 2-Transmissibility Rate and growth rate of the epidemic in intervention sites against the behavior of the epidemic in the rest of the country. (Reproductive number, Ro) Measurement time: weekly (statistical weeks until the end of the epidemic)

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:

None

Inclusion criteria:

1. Male or female subject ≥19 years resident in the areas of intervention of Popular Councils of the Plaza and Centro Habana municipalities, of Havana 2. Subject that gives the Informed Consent

Exclusion criteria:

1. Subject with a history of acute allergic processes. 2. Subject with a history of acute infectious disease at the time of vaccination or in the 7 days prior to the administration of the vaccine 3. Subject with a history of chronic diseases in the decompensation phase 4. Pregnant women-Subjects with known hypersensitivity to any component of the vaccine 5. Subjects with immunomodulatory treatment (immunostimulant or immunosuppressant)

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:

Non-randomized controlled trial

Masking:

Open

Control group:

No intervention

Study design:

Parallel

Phase:

N/A

Target sample size:

115000

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:

Maria

Middle Name:

Eugenia

Last Name:

Toledo Romani

Specialty:

Specialist of second degree in Epidemiology

Affiliation:

"Pedro Kouri" Tropical Medicine Institute (IPK)

Postal Address:

Novia del Mediodia avenue, KM 6 1/2, La Lisa

City:

Havana

Country:

Cuba

Zip Code:

11400

Telephone:

+53772020425, +5372553199

Email :

mariaeugenia@ipk.sld.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:

Dagmar

Last Name:

Garcia Rivera

Specialty:

Biochemistry. PhD in Pharmaceuticals Sciences

Affiliation:

Finlay Vaccine Institute (IFV)

Postal Address:

21 avenue bw/ 198 and 200 Atabey, Playa

City:

Havana

Country:

Cuba

Zip Code:

11600

Telephone:

+537208 0984

Email :

dagarcia@finlay.edu.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

"Pedro Kouri" Tropical Medicine Institute (IPK)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

11/03/2020

Postal address of Ethic Committee :

Novia del Mediodia avenue, KM 6 1/2, CP 11400, La Lisa. Havana. Cuba

Telephone:

+53-72020427

Email:

erick.martinez@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

17000

Study completion date:

30/06/2020

Date of available results:

30/07/2020

Date of first publication:

30/09/2020

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:

RPCEC00000314

Date of Registration in Primary Registry:

22/05/2020

Record Verification Date:

2020/10/21

Next update date:

2021/10/21

Link to the spanish version:

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VA-MENGOC-BC to stimulate the innate response against SARS-CoV-2

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