ABSTRACT
BackgroundVariant-adaptated vaccines against coronavirus disease 2019 (COVID-19) as boosters are needed to increase a broader protection against SARS CoV-2 variants. New adjuvanted recombinant protein vaccines as heterologous boosters could maximize the response. MethodsIn this randomized, single-blinded, multicenter trial, adults who had received two doses of Pfizer-BioNTech mRNA vaccine (BNT162b2) 3 to7 months before were randomly assigned to receive a boost of BNT162b2, Sanofi/GSK SARS-CoV-2 adjuvanted recombinant protein MV D614 (monovalent parental formulation) or SARS-CoV-2 adjuvanted recombinant protein MV B.1.351 vaccine (monovalent Beta formulation). The primary endpoint was the percentage of subjects with a [≥]10-fold increase in neutralizing antibody titers for the Wuhan (D614) and B.1.351 (Beta) SARS-CoV-2 viral strains between day 0 and day 15. FindingsThe percentages of participants whose neutralizing antibody titers against the Wuhan (D614) SARS-CoV-2 strain increased by a factor [≥]10 between day 0 and day 15 was 55.3% (95% CI 43.4-66.7) in MV D614 group (n=76), 76.1% (64.5-85.4) in MV B.1.351 (Beta) group (n=71) and 63.2% (51.3-73.9) in BNT162b2 group (n=76). These percentages were 44.7% (33.3-56.6), 84.5% (74.0-92.0) and 51.3% (39.6-63.0) for the B.1.351 (Beta) viral strain, respectively. Higher neutralizing antibodies rates against Delta and Omicron BA.1 variants were also elicited after Sanofi/GSK MV Beta vaccine compared to the other vaccines. Comparable reactogenicity profile was observed with the three vaccines. InterpretationHeterologous boosting with the Sanofi/GSK Beta formulation vaccine resulted in a higher neutralizing antibody response against Beta variant but also the original strain and Delta and Omicron BA.1 variants, compared with mRNA BNT162b2 vaccine or the Sanofi/GSK MVD614 formulation. New vaccines containing Beta spike protein may represent an interesting strategy for broader protection against SARS CoV-2 variants. FundingFrench Ministries of Solidarity and Health and Research and Sanofi Trial registration numberClinicalTrials.gov identifier NCT05124171; EudraCT identifier 2021-004550-33.
ABSTRACT
Therapeutic plasma exchange (TPE) has been firstly performed with centrifugation devices used in blood banking procedures. Nowadays, TPE is increasingly performed in intensive care units using hemodiafiltration generators that ensure better efficiency and simplicity. However, prescription for the different medical pathologies depends on weak evidence-based recommendations, and is often guided by the clinician's own experience. In this review, we briefly recall the rationale of TPE prescription before discussing the evidence level of common indications of TPE in nephrology. Currently, strong evidence-based data for the benefit of TPE is clearly demonstrated in renal diseases such as hemolytic uremic syndrome, anti-glomerular basement membrane vasculitis, and recurrent glomerulonephritis after kidney transplantation and management of humoral renal allograft rejection in high-risk recipients. However, the other indications of TPE, such as renal vasculitis associated with anti-neutrophil cytoplasmic antibodies, mixed cryoglobulinemia, periarteritis nodosa, and acute renal failure in myeloma are still controversial. Finally, TPE have been found to be clearly inefficient in lupus nephritis, except for patients with associated thrombotic mic-roangiopathy or catastrophic antiphospholipid antibodies syndrome. More randomized clinical trials are required to precisely place TPE in the management of renal diseases. Meanwhile, the decision to use this burdensome and costly therapy should be individualized according to its proven benefits and potential complications.
