Clinical phase II and III studies of an AS03‐adjuvanted H5N1 influenza vaccine produced in an EB66® cell culture platform. Issue 5 (24th June 2020)

• Record Type: Journal Article
• Authors: Endo, Masafumi; Tanishima, Mitsuyoshi; Ibaragi, Kayo; Hayashida, Kenshi; Fukuda, Tadashi; Tanabe, Tetsuro; Naruse, Takeshi; Kino, Yoichiro; Ueda, Kohji
• Is Part Of: Influenza and other respiratory viruses. Volume 14:Issue 5(2020)
• Page Start: 551
• Page End: 563
• Publication Date: 2020-06-24
• Subjects: AS03 -- EB66® cells -- H5N1 influenza; Influenza -- Periodicals; Respiratory infections -- Periodicals; Virus diseases -- Periodicals; Influenza, Human -- Periodicals; Respiratory Tract Diseases -- Periodicals; Virus Diseases -- Periodicals; Grippe -- Périodiques; Appareil respiratoire -- Infections -- Périodiques; Maladies à virus -- Périodiques; 616.203
• DOI: 10.1111/irv.12755
• Languages: English
• ISSNs: 1750-2640

Abstract

Abstract: Background: We have developed an AS03‐adjuvanted H5N1 influenza vaccine produced in an EB66 ® cell culture platform (KD‐295). Objectives: In accordance with Japanese guidelines for development of pandemic prototype vaccines, the phase II study was conducted in a double‐blind, randomized, parallel‐group comparison study and the phase III study was conducted in an open‐label, non‐randomized, uncontrolled study. Methods: Healthy adult volunteers aged 20 ‐ 64 years enrolled in the phase II and III studies (N = 248 and N = 369) received KD‐295 intramuscularly twice with a 21‐day interval. After administration, immune response and adverse events were evaluated. In the phase II study, four different vaccine formulations were compared: MA (3.75 μg hemagglutinin [HA] antigen + AS03 adjuvant system), MB (3.75 μg HA + 1/2AS03), HA (7.5 μg HA + AS03), and HB (7.5 μg HA + 1/2AS03). In the phase III study, the MA formulation was further evaluated. Results: In the phase II study, all four vaccine formulations were well‐tolerated and no SAE related to vaccination were observed. The MA formulation was slightly more immunogenic and less reactogenic among the vaccine formulations. Therefore, the MA formulation was selected for the phase III study, and it was well‐tolerated and no serious adverse drug reactions were observed. The vaccine fulfilled the three immunogenicity criteria described in the Japanese guidelines. Conclusions: These data indicate that the MA formulation of KD‐295 was well‐tolerated and highly immunogenic and it can be considered a useful pandemic and pre‐pandemic influenza vaccine.