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The aim of this study is to explore potential for reduction of incidence and/or morbidity of SARS-CoV-2 infection in healthcare personnel. The study will include a comparison between placebo and RUTI® vaccine in a 2:1 design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group RUTI | Experimental | Participants will receive two dose of RUTI® vaccine at the baseline visit and after 2 weeks +/- 3 days, which will be administered subcutaneously in the deltoid region at a dose of 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli in an injection volume of 0.3 mL. |
|
| Group Placebo | Placebo Comparator | Participants will receive two dose of physiological serum will be administered subcutaneously in the deltoid region at the baseline visit and after 2 weeks +/- 3 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RUTI® vaccine | Biological | Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli in a total volum of 0,3mL. |
| Measure | Description | Time Frame |
|---|---|---|
| Documented cumulative incidence of SARS-CoV-2 infection | Percent of positive serology at the end of the study or positive PCR test in the course of routine clinical practice | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sick leave for SARS-CoV-2 | Number of days of documented sick leave for SARS-CoV-2 | 6 months |
| Days off work due to the quarantine | The number of days off work due to the quarantine imposed as a consequence to have acute respiratory symptoms, fever or infection documented by SARS-CoV-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | All adverse events reported by the subjects, both serious and non-serious, will be collected. All events related to a SARS-CoV-2 infection will be exempted from collection as part of the associated symptoms | 6 months |
Inclusion Criteria:
Sign the Informed Consent before initiating the selection procedures.
Population:
Willingness to meet the requirements of the protocol.
Negative Rapid Serological Test of SARS-CoV-2
The participant must agree to use effective contraceptive methods during the study period, in case of childbearing age.
Exclusion Criteria:
Previous SARS-CoV-2 infection
Pregnancy. Pregnancy test will be performed in case of doubt.
Breastfeeding.
Suspected of active viral or bacterial infection.
Symptoms compatible with COVID-19, despite a negative polymerase chain reaction (PCR) test.
Vaccination in the last 4 weeks or planned vaccination during the study period, except for influenza vaccine.
Participation in a research that requires experimental intervention (does not include observational studies) in the previous month before signing the Consent or during the study.
Severely immunocompromised people. This exclusion category includes:
Malignancy, or active solid or non-solid lymphoma from the previous two years.
Soy allergy.
Direct involvement in the design or execution of the RUTICOVID19 clinical trial.
Retirement, transfer, long-term leave (> 1 month) due to scheduled surgery or any other event that makes it impossible to work in person at your health center during the months following the recruitment to the study.
Do not have a smartphone.
Detection by the researcher of lack of knowledge or willingness to participate and comply with all requirements of the protocol.
16. Any other findings that, at the discretion of the researcher, may compromise compliance with the protocol or that may influence significantly the interpretation or the results of the effects of the vaccine.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de Agudos Dr. Ignacio Pirovano | Buenos Aires | Argentina | ||||
| Hospital Italiano de Buenos Aires |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo | Biological | Physiological serum, 0.9% NaCl, will be used as a placebo. |
|
| 6 months |
| Quarantine imposed by close contact outside the center with SARS-CoV-2 positive | Number of days of quarantine imposed by close contact outside the center with SARS-CoV-2 positive | 6 months |
| Fever | Number of days of self-reported fever (≥38 ºC) | 6 months |
| Incidence of self-reported acute respiratory symptoms | Cumulative incidence of self-reported acute respiratory symptoms | 6 months |
| Days of self-reported acute respiratory symptoms | Number of days of self-reported acute respiratory symptoms | 6 months |
| Incidence of pneumonia | Presence of compatible symptoms and radiological or tomographic focal alteration in the context of a confirmed diagnosis of Covid-19 infection and without evidence of other concomitant pathologies | 6 months |
| Incidence of death from SARS-CoV-2 infection | Cumulative incidence of death from documented SARS-CoV-2 infection | 6 months |
| Incidence of admissions to Intensive Care Unit (ICU) | Cumulative incidence of admissions to intensive care unit for documented SARS-CoV-2 infection | 6 months |
| Days in ICU | Number of days admitted to the ICU for documented SARS-CoV-2 infection | 6 months |
| Incidence of mechanical ventilation | Cumulative incidence of need for mechanical ventilation due to documented SARS-CoV-2 infection | 6 months |
| Incidence of hospital admissions | Cumulative incidence of hospital admissions for documented SARS-CoV-2 infection | 6 months |
| Days of hospitalization | Number of days of hospitalization for documented SARS-CoV-2 infection | 6 months |
| Incidence of SARS-CoV-2 antibodies | Incidence of SARS-CoV-2 antibodies at the end of the study period | Study completion, an average of 1 year |
| Types of antibodies detected | Frequency of immunoglobulin IgG and immunoglobulin IgM | Study completion, an average of 1 year |
| Levels of SARS-CoV-2 antibodies | Levels of SARS-CoV-2 antibodies | Study completion, an average of 1 year |
| Buenos Aires |
| Argentina |
| Hospital General | Mendoza | Argentina |
| Hospital José Néstor Lencinas | Mendoza | Argentina |
| Hospital de Clínicas Presidente Dr. Nicolás Avellaneda | San Miguel de Tucumán | Argentina |
| Hospital Materno Infantil "Dr. Héctor Quintana" | San Salvador de Jujuy | Argentina |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |