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

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) - VME-CORONA

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000314

Enrollment

115000

Registered

2020-05-22

Start date

2020-04-24

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID 19

Interventions

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 i

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Cuba

Contacts

Public ContactMaria Toledo Romani

"Pedro Kouri" Tropical Medicine Institute (IPK)

mariaeugenia@ipk.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Aug 15, 2026