Use of BCG Vaccine as a Preventive Measure for COVID-19 in Health Care Workers (ProBCG)

May 10, 2023 updated by: JOSE ROBERTO LAPA E SILVA, Universidade Federal do Rio de Janeiro
The disease promoted by coronavirus (COVID-19) is caused by Severe Acute Respiratory Syndrome (SARS) caused by Coronavirus type 2 (CoV2), being the first cases identified in December 2019 in China after exposure to the animal market in Wuhan city, China. From the first case to the present day, the COVID-19 epidemic has been identified in 185 countries, with the notification of 2,666,154 cases and 186,144 deaths. In Brazil, more than 45,757 cases and 2,906 confirmed deaths by COVID-19 have been confirmed (Visualized on Apr 23 2020). In our country, to date, testing for COVID-19 occurs only in severe cases and few centers offer the service to health care workers, a population at high risk of infection. BCG is a vaccine produced from a live attenuated strain derived from a Mycobacterium bovis isolate and is widely used worldwide as a tuberculosis (TB) vaccine, but there are studies demonstrating non-specific immunotherapeutic mechanisms of this vaccine that signal a possible relationship with the lowest morbidity and mortality associated with COVID-19 infections worldwide. The present study aims to analyze the role of BCG in the prevention of SARS-CoV-2 infection and also in the occurrence of severe forms of COVID-19 in addition to evaluating the immune response mediated by this vaccine in voluntary health care workers.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Study detailed description can be seen on the protocol attached.

Study Type

Interventional

Enrollment (Anticipated)

752

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio De Janeiro, RJ, Brazil, 21941-590
        • Universidade Federal do Rio de Janeiro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Individuals aged 18 ≥, male or female, not infected with SARS-CoV-2
  2. Agreement to participate in the study by signing the Free Informed Consent (FIC)
  3. Not being pregnant (in case of women able to become pregnant)
  4. Have not received a specific vaccine against COVID-19 or, if vaccinated against SARS-CoV-2, have received the complete immunization schedule only with vaccines approved by ANVISA and implemented by the National Immunization Program, (including the second dose) within a minimum of 15 days prior to the date of inclusion in the study
  5. If the participant have not received a specific vaccine against COVID-19 approved by ANVISA, be aware and agree to be able to receive them only 15 days after the intervention proposed in this study

Exclusion Criteria:

  1. Professionals with a history of SARS-CoV-2 confirmed infection through RT-PCR or who have already presented clinical and molecular diagnosis of COVID-19 prior to the study
  2. Individuals who have not underwent confirmatory tests for COVID-19
  3. Breastfeeding
  4. Individuals with primary or acquired immunodeficiency
  5. Individuals affected by malignant neoplasms
  6. Patients treated with high-dose corticosteroids (equivalent to the prednisone dose of 20 mg/day or more) for more than two weeks
  7. Patients using other immunosuppressive therapies (antineoplastic chemotherapy, radiotherapy, among others)
  8. Individuals with autoimmune diseases
  9. Dermatological conditions at the vaccine site or generalized
  10. Individuals under treatment for active tuberculosis
  11. Individuals with a history of previous tuberculosis treatment
  12. Individuals with febrile symptoms [body temperature ≥ 37.5 celsius degree (ºC) in the last 48h]
  13. Participation in other prevention clinical trials for COVID-19 (vaccines already approved by ANVISA for use by the National Immunization Program are not included in this item)
  14. Report of vaccination with live microorganism administered in the month prior to randomization
  15. Require that, if another vaccination with live microorganism is required, it is administered in the month following randomisation (If the other live vaccine can be administered on the same day, this exclusion criterion does not apply)
  16. Known anaphylactic reaction to any ingredient in BCG vaccine
  17. Adverse reaction prior to BCG vaccine [significant local reaction (abscess) or suppurative lymphadenitis]
  18. BCG vaccine administered in the last year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BCG vaccine
0.1 ml of the reconstituted vaccine to be administered intradermally in the lower insertion of the deltoid muscle, preferably on the right side, in only one occasion
Biological: BCG vaccine
Using aseptic methods, 1 mL of Sterile Water for Injection, is added to one vial of vaccine. Gently swirl the vial until a homogenous suspension is obtained. Avoid forceful agitation which may cause clumping of the mycobacteria. Drop the immunizing dose of 0.1 mL of BCG VACCINE from the syringe and needle onto the cleansed surface of the skin.
Placebo Comparator: 0.9% sodium chloride (NaCl) saline solution
0.1 ml of 0.9% NaCl saline solution to be administered intradermally in the lower insertion of the deltoid muscle, preferably on the right side, in only one occasion
Biological: 0.9% sodium chloride (NaCl) saline solution
A 0.1 ml of 0.9% NaCl saline solution applied intradermally in the lower insertion of the deltoid muscle of the right arm will be used as placebo, except contraindications or impossibilities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the cumulative incidence of SARS-CoV-2 infection
Time Frame: 6 months
It is estimated that it will take 376 individuals in each of the comparison groups to ensure a statistical power of 85% for the detection of a risk difference of 5%, considering that the 6 months of follow-up, for a type I error of 5%.
6 months
Compare the cumulative incidence of severe forms of COVID-19
Time Frame: 6 months
With 376 individuals in each of the comparison groups the study will have a statistical power of approximately 75% for the detection of a risk difference of 2%, considering that the control group will have an accumulated incidence of more severe forms of COVID-19 of 2.5% after 6 months of follow-up, for a type I error of 5%.
6 months
Assess the BCG vaccine-mediated immune response in health care workers
Time Frame: 6 months
SARS-CoV2 infection is estimated to occur in approximately 10% of BCG-vaccinated healthcare professionals (experimental group) and in 30% of non-BCG-vaccinated healthcare professionals (placebo group) In this scenario, with the bearing of 372 health professionals in each arm, SARS-CoV2 infection is expected to be detected in 50 BCG-vaccinated professionals and 150 professionals not vaccinated with BCG. For each subgroup (vaccinated and not vaccinated with BCG) it will be possible to identify the predictive biomarkers of infection by comparing infected professionals with those who were not infected with SARS-CoV2.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Collaborators

Ministry of Science and Technology, Brazil

Investigators

  • Principal Investigator: Fernanda Carvalho de Q Mello, PHD, Universidade Federal do Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

October 1, 2022

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

December 8, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31942220.8.1001.5257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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