Immunogenicity and safety of Biological E’s CORBEVAX™ vaccine compared to COVISHIELD™ (ChAdOx1 nCoV-19) vaccine studied in a phase-3, single blind, multicentre, randomized clinical trial

Abstract

Optimum formulation of Biological-E’s protein subunit CORBEVAX™ vaccine was selected in phase-1 and -2 studies and found to be safe and immunogenic in healthy adult population. This is a phase-3 prospective, single-blinded, randomized, active controlled study conducted at 18 sites across India in 18–80 year-old subjects. This study has two groups; (i) immunogenicity-group, participants randomized either to CORBEVAX™ ( n = 319) or COVISHIELD™ arms ( n = 320). (ii) Safety-group containing single CORBEVAX™ arm ( n = 1500) and randomization is not applicable. Healthy adults without a history of COVID-19 vaccination or SARS-CoV-2 infection were enrolled into immunogenicity arm and subjects seronegative to SARS-CoV-2 infection were enrolled into the safety arm. The safety profile of CORBEVAX™ vaccine was comparable to the comparator vaccine COVISHIELD™. Majority of reported AEs were mild in nature in both arms. The CORBEVAX™ to COVISHIELD™ GMT-ratios at day-42 time-point were 1·15 and 1·56 and the lower limit of the 95% confidence interval for the GMT-ratios was determined as 1·02 and 1·27 against Ancestral and Delta strains of SARS-COV-2 respectively. Both COVISHIELD™ and CORBEVAX™ vaccines showed comparable seroconversion post-vaccination against anti-RBD-IgG response. The subjects in CORBEVAX™ cohort also exhibited higher interferon-gamma secreting PBMC’s post-stimulation with SARS-COV-2 RBD-peptides than subjects in COVISHIELD™ cohort.

Extraordinary Titer and Broad Anti-SARS-CoV-2 Neutralization Induced by Stabilized RBD Nanoparticles from Strain BA.5

“…While this vaccine generates three-fold higher titers in humans than the Oxford-AstraZeneca COVID-19 vaccine [63], our results with WA1 RBD suggest that it may not generate high titer neutralization against current circulating strains. Similar results may hold true for other approved RBD vaccines, such as Corbevax, Abdala, and ZF2001, as well as those in clinical trials, such as mRNA-1283 [64][65][66][67]. Instead, our results indicate that nanoparticles displaying stabilized RBDs from the BA.5 strain should be used, as these RBDs induce substantially higher neutralization titer against current circulating strains.…”

COVID-19 Vaccines: Where Did We Stand at the End of 2023?

“…High neutralizing antibody titers were also obtained for BECOV2 (Corbevax) in phase I/II [ 59 ]. Moreover, in comparison to the Covishield vaccine, Corbevax showed superior immunogenicity and 50% fewer adverse events in phase III [ 60 ]. Corbevax has received EUA in India [ 61 ] and Botswana [ 62 ].…”

“…The BBIBP-CorV vaccine was granted EUA in China in July 2020 [33] and by the WHO in May 2021 [34]. [60] Approval in India [61] and Botswana [62] FINLAY-FR-…”

Clinical development of SpikoGen®, an Advax-CpG55.2 adjuvanted recombinant spike protein vaccine

“…In recent years, multiple new adjuvants have been introduced alongside existing aluminum salt and oil emulsion adjuvants. 21 New adjuvants include ISS1018, a toll-like receptor (TLR)-9 agonist in Heplisav® hepatitis B vaccine, 22 Matrix M, a saponin-based adjuvant in Nuvaxoid COVID-19 vaccine, 23 the alum-CpG adjuvant in Corbevax® RBD vaccine, 24 Alhydroxyquim adjuvant in Bharat biotech’s inactivated COVID-19 vaccine approved in India, 25 ASO1B, an adjuvant containing a liposomal mixture of QS21 and monophosphoryl lipid A (MPL) in Shingrix® shingles vaccine 26 and Mosquirix® malaria vaccine, 27 AS04, an adjuvant comprising MPL absorbed to aluminum phosphate in Fendrix® hepatitis B vaccine, 28 and Vaxine’s own Advax-CpG55.2 adjuvant in SpikoGen® vaccine.…”