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Safety and immunogenicity of a plant-derived rotavirus-like particle vaccine in adults, toddlers and infants.
Kurokawa, Natsuki; Robinson, Michelle K; Bernard, Catherine; Kawaguchi, Yutaka; Koujin, Yoshito; Koen, Anthonet; Madhi, Shabir; Polasek, Thomas M; McNeal, Monica; Dargis, Michèle; Couture, Manon M-J; Trépanier, Sonia; Forrest, Bruce D; Tsutsui, Naohisa.
Afiliação
  • Kurokawa N; Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo 103-8405, Japan. Electronic address: Natsuki.Kurokawa@bms.com.
  • Robinson MK; Oak Hill Consulting, LLC., 1900 Borland Road, Hillsborough, NC 27278, USA.
  • Bernard C; International Regulatory Affairs Services, Inc., 10626 Wagon Box Way, Highlands Ranch, CO 80130, USA.
  • Kawaguchi Y; Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo 103-8405, Japan.
  • Koujin Y; Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo 103-8405, Japan.
  • Koen A; Respiratory and Meningeal Pathogens Research Unit, Chris Hani Baragwanath Hospital, Berstham Chris Hani Road, Soweto 2013, South Africa.
  • Madhi S; Respiratory and Meningeal Pathogens Research Unit, Chris Hani Baragwanath Hospital, Berstham Chris Hani Road, Soweto 2013, South Africa.
  • Polasek TM; Department of Clinical Pharmacology, Royal Adelaide Hospital, Port Road, Adelaide, SA 5000, Australia.
  • McNeal M; Department of Pediatrics, University of Cincinnati College of Medicine, Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, 3333 Burnet Ave, Cincinnati, OH 45229-3039, USA.
  • Dargis M; Medicago Inc., 1020 route de l'Église office 600, Québec, QC, Canada.
  • Couture MM; Medicago Inc., 1020 route de l'Église office 600, Québec, QC, Canada.
  • Trépanier S; Medicago Inc., 1020 route de l'Église office 600, Québec, QC, Canada.
  • Forrest BD; Cognoscenti Bioscience, LLC., PO Box 444, Nyack, NY 10960, USA.
  • Tsutsui N; Mitsubishi Tanabe Pharma Corporation, 17-10, Nihonbashi-Koamicho, Chuo-ku, Tokyo 103-8405, Japan.
Vaccine ; 39(39): 5513-5523, 2021 09 15.
Article em En | MEDLINE | ID: mdl-34454786
BACKGROUND: This study is the first clinical trial for a parenteral non-replicating rotavirus vaccine developed using virus-like particle (VLP) technology. METHODS: This open-labeled, randomized, placebo-controlled trial was conducted in two parts: Part A (a first-in-human study in Australian adults) and Part B (ascending dose and descending age in South African adults, toddlers and infants). In Part A, two cohorts of 10 adults were assigned to receive a single intramuscular injection of 1 of 2 escalating dose levels of the rotavirus VLP (Ro-VLP) vaccine (7 µg or 21 µg) or placebo. In Part B, one cohort of 10 adults was assigned to receive a single injection of the Ro-VLP vaccine (21 µg) or placebo, two cohorts of 10 toddlers were assigned to receive 2 injections of 1 of 2 escalating dose levels of the Ro-VLP vaccine (7 µg or 21 µg) or placebo 28 days apart, and three cohorts of 20 infants were assigned to receive 3 injections of 1 of 3 escalating dose levels of the Ro-VLP vaccine (2.5 µg, 7 µg or 21 µg) or placebo or 2 doses of oral Rotarix 28 days apart. Safety, reactogenicity and immunogenicity were assessed. RESULTS: There were no safety or tolerability concerns after administration of the Ro-VLP vaccine. The Ro-VLP vaccine induced an anti-G1P[8] IgG response in infants 4 weeks after the second and third doses. Neutralizing antibody responses against homologous G1P[8] rotavirus were higher in all Ro-VLP infant groups than in the placebo group 4 weeks after the third dose. No heterotypic immunity was elicited by the Ro-VLP vaccine. CONCLUSIONS: The Ro-VLP vaccine was well tolerated and induced a homotypic immune response in infants, suggesting that this technology platform is a favorable approach for a parenteral non-replicating rotavirus vaccine. CLINICAL TRIAL REGISTRATION: NCT03507738.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Rotavirus / Vacinas contra Rotavirus / Vacinas de Partículas Semelhantes a Vírus Tipo de estudo: Clinical_trials Limite: Adult / Child, preschool / Humans / Infant País/Região como assunto: Oceania Idioma: En Revista: Vaccine Ano de publicação: 2021 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Rotavirus / Vacinas contra Rotavirus / Vacinas de Partículas Semelhantes a Vírus Tipo de estudo: Clinical_trials Limite: Adult / Child, preschool / Humans / Infant País/Região como assunto: Oceania Idioma: En Revista: Vaccine Ano de publicação: 2021 Tipo de documento: Article