The effect of BCG vaccination on infection and antibody levels against SARS-CoV-2-The results of ProBCG: a multicenter randomized clinical trial in Brazil.

OBJECTIVES: Evatuate if Bacillus Calmette-Guérin (BCG) vaccine could be used as a tool against SARS-CoV-2 based on the concept of trained immunity. METHODS: A multicenter, double-blinded, randomized clinical trial recruited health care workers (HCWs) in Brazil. The incidence rates of COVID-19, clinical manifestations, absenteeism, and adverse events among HCWs receiving BCG vaccine (Moreau or Moscow strains) or placebo were compared. BCG vaccine-mediated immune response before and after implementing specific vaccines for COVID-19 (CoronaVac or COVISHIELD) was analyzed. Cox proportional hazard and linear mixed effect modeling were used. RESULTS: A total of 264 volunteers were included for analysis (BCG = 134 and placebo = 130). The placebo group presented a COVID-19 cumulative incidence of 0.75% vs 0.52% of BCG. The Moreau strain also presented a higher incidence rate (1.60% × 0.22%). BCG did not show a protective hazard ratio against COVID-19. In addition, the log (immunoglobulin G) level against SARS-CoV-2 presented a higher increase in the BCG group, whether or not participants had COVID-19, but also without statistical significance. CONCLUSION: Our results suggest that BCG has a tendency of protection against SARS-CoV-2 and higher immunoglobulin G levels than placebo. The clinical trial was registered at https://clinicaltrials.gov/ (NCT04659941).

Analysis of AHG-PRA and ELISA-PRA in kidney transplant patients with acute rejection episodes.

Many centers determined a significant correlation between post-transplant anti-HLA antibodies production and clinical outcome. In order to confirm this correlation and ascertain the sequential appearance of anti-HLA antibodies, we compared the ELISA (ELISA-PRA) and the anti-human globulin enhanced complement-dependent lymphocytotoxicity panel-reactive antibodies test (AHG-PRA) with the occurrence of acute rejection episodes. Thirty patients who underwent kidney transplantation between December 1998 and October 1999 were assayed. One pre-transplant and 10 post-transplant serum samples were tested from each recipient except from one of them who lost his graft on the 1 week post-transplant. The diagnosis of acute rejection episode was based on classical criteria (fever, graft swelling and tenderness, oliguria, weight gain) and a rapid rise in serum creatinine levels, confirmed by an allograft biopsy graded by the Banff working classification. The 322 pre- and post-transplant serum specimens were tested by AHG-PRA methodology and 298 of them by the ELISA-PRA. The agreement coefficient (kappa) for both methodologies was 0.63. There were 27 acute rejection episodes in 19 patients. AHG-PRA results were significantly correlated (Hazard ratio=10.06; P=0.006) with this occurrence. These data were not confirmed with the ELISA-PRA procedure. Our results suggest that a routine post-transplant AHG-PRA test offers an early risk assessment of acute rejection episodes and may be a useful method for monitoring the kidney transplant evolution.