Safety and immunogenicity of a quadrivalent seasonal influenza vaccine adjuvanted with hydroxypropyl-β-cyclodextrin: A phase 1 clinical trial

• DOI: 10.1016/j.vaccine.2022.05.060
• Publication Date: 2022-06-04T11:33:24Z
• Authors: Akane Watanabe; Sumiyuki Nishida; Temizöz Burcu; Takayuki Shibahara; Takato Kusakabe; Etsushi Kuroda; Ken J. Ishii; Atsushi Kumanogoh
• Keywords: Adult; 0303 health sciences; Hemagglutination Inhibition Tests; Antibodies, Viral; 2-Hydroxypropyl-beta-cyclodextrin; 3. Good health; 03 medical and health sciences; Immunogenicity, Vaccine; Adjuvants, Immunologic; Influenza Vaccines; Influenza, Human; Leukocytes, Mononuclear; Humans; Seasons; Vaccines, Combined

Hydroxypropyl-β-cyclodextrin (HP-β-CyD), an oligosaccharide used as excipient in pharmaceutical preparation, was recently reported to function a vaccine adjuvant co-administered antigens. In this study, we investigated the safety and immunogenicity of seasonal influenza adjuvanted with HP-β-CyD (FluCyD-vac) healthy adults compared those standard (Flu-vac).We conducted single-blinded randomized phase 1 clinical trial two quadrivalent split vaccines: FluCyD-vac containing 9 μg HA/strain 20% w/v HP-β-CyD, Flu-vac 15 hemagglutinin (HA)/strain only. All participants were randomly assigned receive single dose Flu/CyD-vac or at ratio 2:1. We assessed solicited unsolicited adverse events (AEs) immune responses using hemagglutination inhibition (HI) titers. addition, T-cell peripheral blood mononuclear cells (PBMCs), after stimulation HA strains, flow cytometry.Among 36 volunteers enrolled study (FluCyD-vac, n = 24; Flu-vac, 12), well tolerated. Most AEs mild local skin reactions injection site. No serious either group. HI titers 21 days vaccination comparable sufficient meet international criteria, despite reduced antigen doses. When PBMCs stimulated four antigens vaccine, tumor necrosis factor (TNF)-α-producing CD4+ T enhanced group.FluCyD-vac well-tolerated immunogenic, 40% less than Flu-vac. This showed that is potentially safe, novel for human vaccine.UMIN000028530.