tetano
Editor, Senior Moderator
J Intern Med
. 2022 May 22.
doi: 10.1111/joim.13523. Online ahead of print.
Randomized clinical trial of BCG vaccine in patients with convalescent COVID-19: Clinical evolution, adverse events, and humoral immune response
Mehrsa Jalalizadeh[SUP] 1 [/SUP], Keini Buosi[SUP] 1 [/SUP], Franciele A V Dionato[SUP] 1 [/SUP], Luciana S B Dal Col[SUP] 1 [/SUP], Cristiane F Giacomelli[SUP] 1 [/SUP], Karen L Ferrari[SUP] 1 [/SUP], Ana Carolina Pagliarone[SUP] 1 [/SUP], Patrícia A F Leme[SUP] 1 [/SUP], Cristiane L Maia[SUP] 1 [/SUP], Reza Yadollahvandmiandoab[SUP] 1 [/SUP], Quoc-Dien Trinh[SUP] 2 [/SUP], Kleber G Franchini[SUP] 3 [/SUP], Marcio C Bajgelman[SUP] 3 [/SUP], Leonardo O Reis[SUP] 1 4 [/SUP]
Affiliations
Abstract
Background: The Bacillus Calmette-Guérin (BCG) vaccine may confer cross-protection against viral diseases in adults. This study evaluated BCG vaccine cross-protection in adults with convalescent coronavirus disease 2019 (COVID-19).
Method: This was a multicenter, prospective, randomized, placebo-controlled, double-blind phase III study (ClinicalTrials.gov: NCT04369794).
Setting: University Community Health Center and Municipal Outpatient Center in South America.
Patients: A total of 378 adult patients with convalescent COVID-19 were included.
Intervention: Single intradermal BCG vaccine (n = 183) and placebo (n = 195).
Measurements: The primary outcome was clinical evolution. Other outcomes included adverse events and humoral immune responses for up to six months.
Results: A significantly higher proportion of BCG patients with anosmia and ageusia recovered at the 6-week follow-up visit than placebo (anosmia: 83.1% vs. 68.7% healed, p = 0.043, number needed to treat [NNT] = 6.9; ageusia: 81.2% vs. 63.4% healed, p = 0.032, NNT = 5.6). BCG also prevented the appearance of ageusia in the following weeks: seven in 113 (6.2%) BCG recipients versus 19 in 126 (15.1%) placebos, p = 0.036, NNT = 11.2. BCG did not induce any severe or systemic adverse effects. The most common and expected adverse effects were local vaccine lesions, erythema (n = 152; 86.4%), and papules (n = 111; 63.1%). Anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) humoral response measured by N protein immunoglobulin G (IgG) titer and seroneutralization by interacting with the angiotensin-converting enzyme 2 (ACE2) receptor suggest that the serum of BCG-injected patients may neutralize the virus at lower specificity; however, the results were not statistically significant.
Conclusion: BCG vaccine is safe and offers cross-protection against COVID-19 with potential humoral response modulation.
Limitations: No severely ill patients were included. This article is protected by copyright. All rights reserved.
Keywords: BCG; COVID-19; IgG; SARS-CoV-2; convalescence; immunomodulation; neutralization; safety.
. 2022 May 22.
doi: 10.1111/joim.13523. Online ahead of print.
Randomized clinical trial of BCG vaccine in patients with convalescent COVID-19: Clinical evolution, adverse events, and humoral immune response
Mehrsa Jalalizadeh[SUP] 1 [/SUP], Keini Buosi[SUP] 1 [/SUP], Franciele A V Dionato[SUP] 1 [/SUP], Luciana S B Dal Col[SUP] 1 [/SUP], Cristiane F Giacomelli[SUP] 1 [/SUP], Karen L Ferrari[SUP] 1 [/SUP], Ana Carolina Pagliarone[SUP] 1 [/SUP], Patrícia A F Leme[SUP] 1 [/SUP], Cristiane L Maia[SUP] 1 [/SUP], Reza Yadollahvandmiandoab[SUP] 1 [/SUP], Quoc-Dien Trinh[SUP] 2 [/SUP], Kleber G Franchini[SUP] 3 [/SUP], Marcio C Bajgelman[SUP] 3 [/SUP], Leonardo O Reis[SUP] 1 4 [/SUP]
Affiliations
- PMID: 35599154
- DOI: 10.1111/joim.13523
Abstract
Background: The Bacillus Calmette-Guérin (BCG) vaccine may confer cross-protection against viral diseases in adults. This study evaluated BCG vaccine cross-protection in adults with convalescent coronavirus disease 2019 (COVID-19).
Method: This was a multicenter, prospective, randomized, placebo-controlled, double-blind phase III study (ClinicalTrials.gov: NCT04369794).
Setting: University Community Health Center and Municipal Outpatient Center in South America.
Patients: A total of 378 adult patients with convalescent COVID-19 were included.
Intervention: Single intradermal BCG vaccine (n = 183) and placebo (n = 195).
Measurements: The primary outcome was clinical evolution. Other outcomes included adverse events and humoral immune responses for up to six months.
Results: A significantly higher proportion of BCG patients with anosmia and ageusia recovered at the 6-week follow-up visit than placebo (anosmia: 83.1% vs. 68.7% healed, p = 0.043, number needed to treat [NNT] = 6.9; ageusia: 81.2% vs. 63.4% healed, p = 0.032, NNT = 5.6). BCG also prevented the appearance of ageusia in the following weeks: seven in 113 (6.2%) BCG recipients versus 19 in 126 (15.1%) placebos, p = 0.036, NNT = 11.2. BCG did not induce any severe or systemic adverse effects. The most common and expected adverse effects were local vaccine lesions, erythema (n = 152; 86.4%), and papules (n = 111; 63.1%). Anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) humoral response measured by N protein immunoglobulin G (IgG) titer and seroneutralization by interacting with the angiotensin-converting enzyme 2 (ACE2) receptor suggest that the serum of BCG-injected patients may neutralize the virus at lower specificity; however, the results were not statistically significant.
Conclusion: BCG vaccine is safe and offers cross-protection against COVID-19 with potential humoral response modulation.
Limitations: No severely ill patients were included. This article is protected by copyright. All rights reserved.
Keywords: BCG; COVID-19; IgG; SARS-CoV-2; convalescence; immunomodulation; neutralization; safety.