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Immunogenicity and safety of the homogenous booster shot of a recombinant fusion protein vaccine (V-01) against COVID-19 in healthy adult participants primed with a two-dose regimen
Yuan Li; Xin Fang; Rongjuan Pei; Renfeng Fan; Shaomin Chen; Peiyu Zeng; Zhiqiang Ou; Jinglong Deng; Jian Zhou; Zehui Sun; Lishi Liu; Hua Peng; Xujia Chen; Zhipeng Su; Xi Chen; Jianfeng He; Wuxiang Guan; Zhongyu Hu; Yang-Xin Fu; Jikai Zhang.
Afiliación
  • Yuan Li; Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, China
  • Xin Fang; National Institutes for Food and Drug Control, Beijing, China
  • Rongjuan Pei; Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, China
  • Renfeng Fan; Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, China
  • Shaomin Chen; Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, China
  • Peiyu Zeng; Gaozhou Center for Disease Control and Prevention, Maoming, China
  • Zhiqiang Ou; Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, China
  • Jinglong Deng; Gaozhou Center for Disease Control and Prevention, Maoming, China
  • Jian Zhou; Gaozhou Center for Disease Control and Prevention, Maoming, China
  • Zehui Sun; Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, China
  • Lishi Liu; Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, China
  • Hua Peng; Key Laboratory of Infection and Immunity, Institute of Biophysics, Chinese Academy of Sciences, Beijing, China
  • Xujia Chen; LivzonBio Inc., Zhuhai, China
  • Zhipeng Su; LivzonBio Inc., Zhuhai, China
  • Xi Chen; LivzonBio Inc., Zhuhai, China
  • Jianfeng He; Guangdong Provincial Center for Disease Control and Prevention, Guangzhou, China
  • Wuxiang Guan; Wuhan Institute of Virology Chinese Academy of Sciences
  • Zhongyu Hu; National Institutes for Food and Drug Control, Beijing, China
  • Yang-Xin Fu; Department of Basic Medical Sciences, School of Medicine, Tsinghua University, Beijing, China
  • Jikai Zhang; Guangdong Provincial Institute of Biological Products and Materia Medica, Guangzhou, China
Preprint en Inglés | medRxiv | ID: ppmedrxiv-21265780
ABSTRACT
BackgroundRising concerns over waning immunity and reduction in neutralizing activity against variants of concern (VOCs) have contributed to deploying booster doses by different strategies to tackle the COVID-19 pandemic. Preliminary findings from Phase I and II have shown that V-01, a recombinant fusion protein vaccine against COVID-19, exhibited favorable safety and immunogenicity profiles in 1060 adult participants of both younger and senior age. Herein, we aimed to assess the immunogenicity and safety for a booster dose in participants previously primed with a two-dose 10g V-01 regimen (day 0, 21) from phase I trial, providing reassuring data for necessity and feasibility of a homogenous booster dose. MethodsWe conducted a single-arm, open-label trial at the Guangdong Provincial Center for Disease Control and Prevention (Gaozhou, China). Forty-three eligible participants who were previously primed 4-5 months earlier with two-dose 10g V-01 regimen from phase I trial received booster vaccination. We primarily assessed the immunogenicity post-booster vaccination, measured by RBD-binding antibodies using ELISA and neutralizing activity against wild-type SARS-CoV-2 and emerging variants of concern (VOCs) using neutralization assays. We secondarily assessed the safety and reactogenicity of the booster vaccination. ResultsThe third dose of V-01 exhibited significant boosting effects of humoral immune response in participants primed with two-dose 10g V-01 regimen regarding both wild-type SARS-CoV-2 and VOCs. We observed a 60.4-folds increase in neutralizing titres against SARS-CoV-2 of younger adults, with GMTs of 17 (95%CI 12-23) prior to booster vaccination in comparison to 1017 (95%CI 732-1413) at day 14 post booster vaccination; and a 53.6-folds increase in that of older adults, with GMTs of 14 (95%CI 9-20) before booster vaccination in comparison to 729(95%CI 397-1339) at day 14 post-booster vaccination. The neutralizing titres against SARS-CoV-2 Delta strain also demonstrated a sharp increase from the day of pre booster vaccination to day 14 post booster vaccination, with GMTs of 11 (95%CI8-15) versus 383 (95%CI277-531) in younger adults (35.4-folds increase), and 6.5(95%CI 5-8) versus 300(95%CI142-631) in older adults (46.0-folds increase), respectively. We also observed a considerable and consistent increase of pseudovirus neutralizing titres against emerging VOCs from day 28 post second vaccination to day 14 post booster vaccination, with GMTs of 206 (95%CI163-259) versus 607 (95%CI 478-771) for Alpha strain, 54 (95%CI38-77) versus 329 (95%CI 255-425) for Beta strain, 219 (95%CI157-306) versus 647 (95%CI 484-865) for Delta strain. Our preliminary findings indicate a homogenous booster dose of V-01 was safe and well-tolerated, with overall adverse reactions being absent or mild-to-moderate in severity, and no grade 3 or worse AEs were related to booster vaccination. ConclusionsA homogenous booster immunization in participants receiving a primary series of two-dose V-01 elicited a substantial humoral immune response against wild-type SARS-CoV-2 and emerging VOCs, along with a favorable safety and reactogenicity profile. Our study provided promising data for a homogenous prime-boost strategy using recombinant protein vaccine to tackle the ongoing pandemic, potentially providing broad protection against emerging VOCs and overcoming waning immunity.
Licencia
cc_by_nc_nd
Texto completo: Disponible Colección: Preprints Base de datos: medRxiv Tipo de estudio: Experimental_studies / Estudio pronóstico / Rct Idioma: Inglés Año: 2021 Tipo del documento: Preprint
Texto completo: Disponible Colección: Preprints Base de datos: medRxiv Tipo de estudio: Experimental_studies / Estudio pronóstico / Rct Idioma: Inglés Año: 2021 Tipo del documento: Preprint
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