BCG (Bacillus Calmette-Guérin) vaccine: Application of BCG vaccine (0.1 ml intradermal) in the right arm deltoid insertion
Placebo: Application of BCG solvent (0.1 ml intradermal) in the right arm deltoid insertion
Study summary
Clinical trial with randomized allocation in two arms (BCG vaccine versus placebo) of volunteers at risk but not yet infected nor vaccinated against SARS-CoV-2. Initially will be evaluated whether BCG has a protective role against severe form of the disease. After participants are vaccinated against COVID-19, it will be evaluated whether BCG favors the vaccine's efficacy. Volunteers will be recruited in three Brazilian states, with at least 250 seronegative in each group. The BCG-trained immunity stimulus will be investigated by assessing cytokines at D0 and D60 in a subsample of 50 participants per group. Until being vaccinated against COVID-19, the participants will be followed for up to 6 months, with visits scheduled every 2 months for interviews and immunoglobulin G (IgG) anti-SARS-CoV-2 antibodies. Those who become symptomatic at any time during the follow-up will be guided and monitored remotely daily until the end of their clinical evolution. After being vaccinated against COVID-19, visits to participants will be adjusted for the time of vaccination (VD), 20 days after the 1st dose (P1) and at least 30 days (P2) after the 2nd dose, with the aim of comparing the efficacy of the anti-SARS-CoV-2 vaccine in the two groups in the short and medium term.
The study's conclusions on the efficacy of BCG in preventing severe COVID-19 will be based on: incidence of SARS-Cov-2 infection (defined as the emergence of IgG over the follow-up period); incidence of illness by COVID-19 (defined as the presence of symptoms among infected participants); intensity and duration of symptoms between cases of COVID-19 and frequency and duration of hospitalizations for COVID-19 in each group. The occurrence, type, frequency and intensity of adverse effects associated with vaccination of adults with BCG will be reported.
The study's conclusions regarding the effect of BCG on efficacy of vaccines against COVID-19 will be based on: frequency of anti-SARS-CoV-2 neutralizing antibodies after the vaccine' 1st and 2nd doses in both groups.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
INCLUSION CRITERIA:
* Never been infected by SARS-Cov-2 - clinical history and absence of anti-SARS-CoV-2 IgM/IgG antibodies by the rapid test (immediate) and by serology test (later confirmation)
* Not having been vaccinated against COVID-19
* Be at least 18 years old
EXCLUSION CRITERIA:
* Have been vaccinated with BCG less than 6 months ago
* Have been vaccinated with BCG more than once in the past
* Present any classic contraindications for BCG - pregnancy, breastfeeding, acute febrile illness, severe allergy to one of the components, vaccination with other live vaccines in the last month (measles, yellow fever, herpes zoster), immunosuppression for any cause (congenital, illness, use of corticosteroids or immunosuppressants)
* Have had tuberculosis or contacted someone with tuberculosis
* Present signs of any current acute illness or have had a severe illness less than 15 days
* Present a skin lesion at the vaccine application site (right deltoid muscle)
* History of severe allergic reactions to any product: urticaria, glottis edema, angioedema, respiratory failure, bronchospasm
* History of serious autoimmune diseases: systemic lupus erythematosus, Crohn's disease, ulcerative colitis, multiple sclerosis, hemolytic anemia, ankylosing spondylitis, pemphigus and others
* Immunocompromise for any reason (congenital, illness, use of corticosteroids or immunosuppressants)
* Presenting a risk comorbidity for severe COVID-19, such as: poorly controlled hypertension, decompensated heart disease (chronic, congenital or ischemic), pulmonary disease (chronic pneumopathy, poorly controlled asthma, chronic interstitial pneumopathy, others ...), disease advanced chronic kidney disease (use of dialysis), transplantation (of solid organs or bone marrow), uncontrolled diabetes
Primary outcome measure(s)
Incidence of SARS-Cov-2 infection in both groups over the follow-up — Up to six months from recruitment day Appearance of IgG antibodies (seroconversion) in the participants not yet vaccinated against COVID-19
Incidence of illness by COVID-19 in both groups over the follow-up — Up to six months from recruitment day Presence of symptoms among subjects not vaccinated against COVID-19 diagnosed with infection after D0 or seroconverted
Intensity of the efficacy of the first dose of the vaccine against COVID-19 — Up to six months from recruitment day Comparison of groups regarding frequency and titer (UI/ml) of anti-SARS-CoV-2 neutralizing antibodies after first dose of the specific vaccine, through the qualitative and semi-quatitative "SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT)" Genscript Kit
Duration of the efficacy of the second dose of the vaccine against COVID-19 — One year from recruitment day Comparison of groups regarding frequency and titer (UI/ml) of anti-SARS-CoV-2 neutralizing antibodies after second dose of the specific vaccine, through the qualitative and semi-quatitative "SARS-CoV-2 Surrogate Virus Neutralization Test (sVNT)" Genscript Kit
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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