Safety and immunogenicity of PIKA-adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine as a booster against SARS-CoV-2: a phase II, open-label, randomized, double-blinded study.

Autor:	Lim RJ; YS Biopharma Co. Ltd., Bonifacio Global City, Taguig, Philippines., Qiu X; YS Biopharma (China) Co. Ltd., Beijing, China., Alberto E; Clinical Research Center, Health Index Multispecialty Clinic, Imus, Philippines., Capeding MR; Clinical Research Unit, Tropical Disease Foundation, Muntinlupa, Philippines., Carlos J; Research Center, University of the East Ramon Magsaysay Memorial Medical Center Inc., Quezon City, Philippines., Leong RN; YS Biopharma Co. Ltd., Bonifacio Global City, Taguig, Philippines., Gutierrez JL; YS Biopharma Co. Ltd., Bonifacio Global City, Taguig, Philippines., Trillana M; YS Biopharma Co. Ltd., Bonifacio Global City, Taguig, Philippines., Liu Y; YS Biopharma (China) Co. Ltd., Beijing, China., Mojares Z; YS Biopharma (Singapore) Co. Ltd., Singapore, Singapore.
Jazyk:	angličtina
Zdroj:	Clinical and experimental vaccine research [Clin Exp Vaccine Res] 2024 Oct; Vol. 13 (4), pp. 329-337. Date of Electronic Publication: 2024 Oct 31.
DOI:	10.7774/cevr.2024.13.4.329
Abstrakt:	Purpose: This study evaluated the safety and immunogenicity of the PIKA-adjuvanted recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein subunit vaccine as a booster dose for healthy adults who had previously received two or more doses of an inactivated coronavirus disease 2019 (COVID-19) vaccine. Materials and Methods: The study was a phase II multicenter, double-blinded, comparator-controlled, randomized trial. Participants were randomly assigned to receive either the PIKA COVID-19 vaccine booster dose or an inactivated COVID-19 vaccine (Sinovac, China). Safety was assessed based on adverse events, while immunogenicity was measured by neutralizing antibodies against SARS-CoV-2 and serum immunoglobulin G (IgG) levels. Data on safety and immunogenicity were collected in the short-term (within 14 days after the booster dose) and long-term (from 90 to 365 days after the booster dose). Results: The PIKA-adjuvanted vaccine demonstrated a significant increase in neutralizing antibodies against the Omicron variant (geometric mean ratio [GMR]=2.0 on day 7, p-value <0.001; GMR=2.7 on day 14, p-value <0.001) and the wild type SARS-CoV-2 virus (GMR=2.3 on day 7, p-value <0.001; GMR=2.8 on day 14, p-value<0.001) in the early post-vaccination period when compared to the inactivated vaccine. Additionally, the PIKA COVID-19 vaccine showed higher seroconversion rates for neutralizing antibodies against both variants during the first 14 days post-vaccination. However, there were no significant differences in neutralizing antibody levels between the two vaccines from day 90 to day 360 post-vaccination. Serum IgG antibody levels for the PIKA COVID-19 vaccine were also higher throughout the study period. The incidence of adverse events was slightly higher in the PIKA COVID-19 group, with the most common events being pain at the injection site and headache. All adverse events were mild or moderate, with no reports of severe or life-threatening adverse events in either group. Conclusion: The PIKA COVID-19 vaccine, when administered as a booster dose, showed promising short- and long-term immunogenicity with no emergent safety issues identified. The booster dose of the PIKA COVID-19 vaccine elicited a robust immune response against various SARS-CoV-2 variants and provided some seroprotection for up to 360 days (ClinicalTrials.gov registration number: NCT05463419). (© Korean Vaccine Society.)
Databáze:	MEDLINE
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