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Phase I interim results of a phase I/II study of the IgG-Fc fusion COVID-19 subunit vaccine, AKS-452.
Janssen, Yester F; Feitsma, Eline A; Boersma, Hendrikus H; Alleva, David G; Lancaster, Thomas M; Sathiyaseelan, Thillainaygam; Murikipudi, Sylaja; Delpero, Andrea R; Scully, Melanie M; Ragupathy, Ramya; Kotha, Sravya; Haworth, Jeffrey R; Shah, Nishit J; Rao, Vidhya; Nagre, Shashikant; Ronca, Shannon E; Green, Freedom M; Aminetzah, Ari; Sollie, Frans; Kruijff, Schelto; Brom, Maarten; van Dam, Gooitzen M; Zion, Todd C.
  • Janssen YF; Department of Surgery, University Medical Center Groningen (UMCG), Hanzeplein 1, 9700 RB Groningen, the Netherlands.
  • Feitsma EA; Department of Surgery, University Medical Center Groningen (UMCG), Hanzeplein 1, 9700 RB Groningen, the Netherlands.
  • Boersma HH; Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen (UMCG), Hanzeplein 1, 9700 RB Groningen, the Netherlands; Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen (UMCG), Hanzeplein 1, 9700 RB Groningen, the Netherlands.
  • Alleva DG; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Lancaster TM; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Sathiyaseelan T; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Murikipudi S; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Delpero AR; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Scully MM; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Ragupathy R; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Kotha S; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Haworth JR; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Shah NJ; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Rao V; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Nagre S; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States.
  • Ronca SE; Feigin ABSL-3 Facility, Department of Pediatrics-Division of Tropical Medicine, Baylor College of Medicine and Texas Children's Hospital, 1102 Bates Ave, 300.15, Houston, TX 77030, United States.
  • Green FM; Feigin ABSL-3 Facility, Department of Pediatrics-Division of Tropical Medicine, Baylor College of Medicine and Texas Children's Hospital, 1102 Bates Ave, 300.15, Houston, TX 77030, United States.
  • Aminetzah A; TRACER BV, L.J. Zielstraweg 1, 9766 GX Groningen, the Netherlands.
  • Sollie F; ICON, van Swietenlaan 6, 9728 NZ 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, University Medical Center Groningen (UMCG), Hanzeplein 1, 9700 RB Groningen, the Netherlands.
  • Brom M; TRACER BV, L.J. Zielstraweg 1, 9766 GX Groningen, the Netherlands.
  • van Dam GM; TRACER BV, L.J. Zielstraweg 1, 9766 GX Groningen, the Netherlands.
  • Zion TC; Akston Biosciences Corporation, 100 Cummings Center, Suite 454C, Beverly, MA 01915, United States. Electronic address: todd.zion@akstonbio.com.
Vaccine ; 40(9): 1253-1260, 2022 02 23.
Article in English | MEDLINE | ID: covidwho-1721051
ABSTRACT
To address the coronavirus disease 2019 (COVID-19) pandemic caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a recombinant subunit vaccine, AKS-452, is being developed comprising an Fc fusion protein of the SARS-CoV-2 viral spike protein receptor binding domain (SP/RBD) antigen and human IgG1 Fc emulsified in the water-in-oil adjuvant, Montanide™ ISA 720. A single-center, open-label, phase I dose-finding and safety study was conducted with 60 healthy adults (18-65 years) receiving one or two doses 28 days apart of 22.5 µg, 45 µg, or 90 µg of AKS-452 (i.e., six cohorts, N = 10 subjects per cohort). Primary endpoints were safety and reactogenicity and secondary endpoints were immunogenicity assessments. No AEs ≥ 3, no SAEs attributable to AKS-452, and no SARS-CoV-2 viral infections occurred during the study. Seroconversion rates of anti-SARS-CoV-2 SP/RBD IgG titers in the 22.5, 45, and 90 µg cohorts at day 28 were 70%, 90%, and 100%, respectively, which all increased to 100% at day 56 (except 89% for the single-dose 22.5 µg cohort). All IgG titers were Th1-isotype skewed and efficiently bound mutant SP/RBD from several SARS-CoV-2 variants with strong neutralization potencies of live virus infection of cells (including alpha and delta variants). The favorable safety and immunogenicity profiles of this phase I study (ClinicalTrials.gov NCT04681092) support phase II initiation 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Observational study / Prognostic study Topics: Vaccines / Variants Limits: Adolescent / Adult / Aged / Humans / Middle aged / Young adult Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.01.043

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Cohort study / Observational study / Prognostic study Topics: Vaccines / Variants Limits: Adolescent / Adult / Aged / Humans / Middle aged / Young adult Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.01.043