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Clinical Trial Evaluating the Effect of BCG Vaccination on the Incidence and Severity of SARS-CoV-2 Infections Among Healthcare Professionals During the COVID-19 Pandemic in Poland

NCT04648800 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2020-12-02

No results posted yet for this study

Summary

Countries that have not carried out universal mass vaccination against tuberculosis (BCG) have been shown to have higher incidence and death rates due to COVID-19 than countries with mass, long-term BCG immunization programmes.

The aim of the study is to answer the following questions:

1. Does BCG vaccination affect the course of COVID-19 (number of cases/deaths/severity of symptoms)?
2. Will the course of COVID-19 be milder among subjects with a negative TB skin test (PPD RT 23 SSI) after an additional dose of BCG than in case of non-vaccinated subjects?
3. Do people with a positive TB skin test have a milder course of COVID-19 infection than people with a negative test result?

A multicenter, randomized, partially blinded, placebo-controlled study will be conducted in Rzeszow/Krakow/ Katowice/Warsaw on a group of 1000 volunteers, health care workers according to the following schedule: V 0-1: inclusion/informed consent/interview; V2: administration of TB skin test/anti-SARS-CoV-2 IgG test/serum banking\*; V3: TB skin test (TST) interpretation and subjects' division into three groups: (I) positive TST - observation; (II) negative TST- BCG-10 vaccination; (III) negative TST - placebo. Division into groups II and III based on randomisation; V4: serum banking\*. Parallel beginning from V3, weekly telephone monitoring participants' health status; In case of COVID-19 symptoms a nasopharyngeal swab to confirm SARS-CoV-2 infection + serum banking\*. V5: 3 months after vaccination at the end of the study: history/anti-SARS-CoV-2 IgG test, serum banking\*.

Statistical analysis - comparison of the course of COVID-19 in groups: (I) with positive TST + observation, (II) with negative TST + BCG, (III) with negative TST + placebo - should demonstrate whether mass BCG vaccination has an impact on the incidence and course of COVID-19.

\* to measure the level of cytokines involved in cell-mediated immunity process

Conditions

  • Covid19
  • BCG Vaccination Reaction
  • SARS-CoV Infection

Interventions

DRUG

BCG-10 vaccine

The BCG-10 anti-tuberculosis vaccine * powder and solvent for preparing a suspension for intradermal injections of Vaccinum tuberculosis (BCG) cryodesiccatum; * lyophilised BCG vaccine * one dose (0.1 ml) contains 50 micrograms of half-dried mass of BCG mycobacteria, which corresponds to 150,000 - 600,000 of live BCG bacilli- the Brazilian Moreau sub-strain.

DRUG

0.9% saline

0.9% saline

Sponsors & Collaborators

  • Medical Research Agency, Poland

    collaborator OTHER_GOV

  • Hanna Czajka

    lead OTHER

Principal Investigators

  • Hanna Czajka, prof. · College of Medical Sciences, University of Rzeszów

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2020-12-31
Completion
2021-04-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04648800 on ClinicalTrials.gov