Immunogenicity phase II study evaluating booster capacity of nonadjuvanted AKS-452 SARS-Cov-2 RBD Fc vaccine.

Autor: Alleva DG; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Feitsma EA; Department of Surgery, University Medical Center Groningen (UMCG), Hanzeplein 1, 9700 RB, Groningen, The Netherlands., Janssen YF; Department of Nuclear Medicine and Molecular Imaging, UMCG, Groningen, The Netherlands., Boersma HH; Department of Nuclear Medicine and Molecular Imaging, UMCG, Groningen, The Netherlands.; Department of Clinical Pharmacy and Pharmacology, UMCG, Groningen, The Netherlands., Lancaster TM; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Sathiyaseelan T; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Murikipudi S; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Delpero AR; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Scully MM; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Ragupathy R; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Kotha S; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Haworth JR; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Shah NJ; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Rao V; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Nagre S; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA., Ronca SE; Department of Pediatrics, Division of Tropical Medicine, Baylor College of Medicine and Texas Children's Hospital, Baylor, College of Medicine, 1102 Bates Ave, 300.15, Houston, TX, 77030, USA., Green FM; Department of Pediatrics, Division of Tropical Medicine, Baylor College of Medicine and Texas Children's Hospital, Baylor, College of Medicine, 1102 Bates Ave, 300.15, Houston, TX, 77030, USA., Shaw SA; Department of Pediatrics, Division of Tropical Medicine, Baylor College of Medicine and Texas Children's Hospital, Baylor, College of Medicine, 1102 Bates Ave, 300.15, Houston, TX, 77030, USA., Aminetzah A; TRACER BV, Aarhusweg 2-1/2-2, 9723 JJ, Groningen, The Netherlands., Kruijff S; Department of Surgery, University Medical Center Groningen (UMCG), Hanzeplein 1, 9700 RB, Groningen, The Netherlands.; Department of Nuclear Medicine and Molecular Imaging, UMCG, Groningen, The Netherlands., Brom M; TRACER BV, Aarhusweg 2-1/2-2, 9723 JJ, Groningen, The Netherlands., van Dam GM; Department of Nuclear Medicine and Molecular Imaging, UMCG, Groningen, The Netherlands.; TRACER BV, Aarhusweg 2-1/2-2, 9723 JJ, Groningen, The Netherlands., Zion TC; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA, 01915, USA. todd.zion@akstonbio.com.
Jazyk: angličtina
Zdroj: NPJ vaccines [NPJ Vaccines] 2024 Feb 21; Vol. 9 (1), pp. 40. Date of Electronic Publication: 2024 Feb 21.
DOI: 10.1038/s41541-024-00830-2
Abstrakt: AKS-452, a subunit vaccine comprising an Fc fusion of the ancestral wild-type (WT) SARS-CoV-2 virus spike protein receptor binding domain (SP/RBD), was evaluated without adjuvant in a single cohort, non-randomized, open-labelled phase II study (NCT05124483) at a single site in The Netherlands for safety and immunogenicity. A single 90 µg subcutaneous booster dose of AKS-452 was administered to 71 adults previously primed with a registered mRNA- or adenovirus-based vaccine and evaluated for 273 days. All AEs were mild and no SAEs were attributable to AKS-452. While all subjects showed pre-existing SP/RBD binding and ACE2-inhibitory IgG titers, 60-68% responded to AKS-452 via ≥2-fold increase from days 28 to 90 and progressively decreased back to baseline by day 180 (days 28 and 90 mean fold-increases, 14.7 ± 6.3 and 8.0 ± 2.2). Similar response kinetics against RBD mutant proteins (including omicrons) were observed but with slightly reduced titers relative to WT. There was an expected strong inverse correlation between day-0 titers and the fold-increase in titers at day 28. AKS-452 enhanced neutralization potency against live virus, consistent with IgG titers. Nucleocapsid protein (Np) titers suggested infection occurred in 66% (46 of 70) of subjects, in which only 20 reported mild symptomatic COVID-19. These favorable safety and immunogenicity profiles support booster evaluation in a planned phase III universal booster study of this room-temperature stable vaccine that can be rapidly and inexpensively manufactured to serve vaccination at a global scale without the need of a complex distribution or cold chain.
(© 2024. The Author(s).)
Databáze: MEDLINE
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