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Immunogenicity and safety of booster dose of S-268019-b or BNT162b2 in Japanese participants: An interim report of phase 2/3, randomized, observer-blinded, noninferiority study.
Shinkai, Masaharu; Sonoyama, Takuhiro; Kamitani, Akari; Shibata, Risa Yokokawa; Seki, Naomi M; Omoto, Shinya; Shinoda, Masahiro; Sato, Takashi; Ishii, Naoki; Igarashi, Kenji; Ariyasu, Mari.
  • Shinkai M; Department of Respiratory Medicine, Tokyo Shinagawa Hospital, 6-3-22 Higashioi, Shinagawa-ku, Tokyo 140-8522, Japan.
  • Sonoyama T; Shionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan.
  • Kamitani A; Shionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan.
  • Shibata RY; Shionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan.
  • Seki NM; Shionogi & Co., Ltd., Pharmaceutical Research Division, 1-1, Futaba-cho 3-chome, Toyonaka, Osaka 561-0825, Japan.
  • Omoto S; Shionogi & Co., Ltd., Pharmaceutical Research Division, 1-1, Futaba-cho 3-chome, Toyonaka, Osaka 561-0825, Japan.
  • Shinoda M; Department of Respiratory Medicine, Tokyo Shinagawa Hospital, 6-3-22 Higashioi, Shinagawa-ku, Tokyo 140-8522, Japan.
  • Sato T; Department of Respiratory Medicine, Tokyo Shinagawa Hospital, 6-3-22 Higashioi, Shinagawa-ku, Tokyo 140-8522, Japan.
  • Ishii N; Department of Gastroenterology, Tokyo Shinagawa Hospital, 6-3-22 Higashioi, Shinagawa-ku, Tokyo 140-8522, Japan.
  • Igarashi K; Shionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan.
  • Ariyasu M; Shionogi & Co., Ltd., Drug Development and Regulatory Science Division, 8F, Nissay Yodoyabashi East Bldg., 3-3-13, Imabashi, Chuo-ku, Osaka 541-0042, Japan. Electronic address: mari.tatsuno@shionogi.co.jp.
Vaccine ; 40(32): 4328-4333, 2022 07 30.
Article in English | MEDLINE | ID: covidwho-1895480
ABSTRACT
In this randomized, observer-blinded, phase 2/3 study, S-268019-b (n = 101), a recombinant spike protein vaccine, was analyzed for noninferiority versus BNT162b2 (n = 103), when given as a booster ≥6 months after 2-dose BNT162b2 regimen in Japanese adults without prior SARS-CoV-2 infection. Interim results showed noninferiority of S-268019-b versus BNT162b2 in co-primary endpoints for neutralizing antibodies on day 29 geometric mean titer (GMT) (124.97 versus 109.70; adjusted-GMT ratio [95% CI], 1.14 [0.94-1.39]; noninferiority P-value, <0.0001) and seroresponse rate (both 100%; noninferiority P-value, 0.0004). Both vaccines elicited anti-spike-protein immunoglobulin G antibodies, and produced T-cell response (n = 29/group) and neutralizing antibodies against Delta and Omicron pseudovirus and live virus variants (n = 24/group) in subgroups. Most participants reported low-grade reactogenicity on days 1-2, the most frequent being fatigue, fever, myalgia, and injection-site pain. No serious adverse events were reported. In conclusion, S-268019-b was safe and showed robust immunogenicity as a booster, supporting its use as COVID-19 booster vaccine.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / BNT162 Vaccine Type of study: Experimental Studies / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Country/Region as subject: Asia Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.06.032

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 / BNT162 Vaccine Type of study: Experimental Studies / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Humans Country/Region as subject: Asia Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.06.032