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A Phase I, Prospective, Randomized, Open-labeled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Booster Dose with MVC-COV1901 or MVC-COV1901(Beta) SARS-CoV-2 Vaccine in Adults
Chia En Lien; Ming-Che Liu; Ning-Chi Wang; Luke Tzu -Chi Liu; Chung-Chin Wu; Wei-Hsuan Tang; Wei-Cheng Lian; Kuan-Ying A Huang; Charles Chen.
Affiliation
  • Chia En Lien; Medigen Vaccine Biologics Corp.
  • Ming-Che Liu; Taipei Medical University
  • Ning-Chi Wang; Tri-Service General Hospital
  • Luke Tzu -Chi Liu; Medigen Vaccine Biologics Corp
  • Chung-Chin Wu; Medigen Vaccine Biologics Corp
  • Wei-Hsuan Tang; Medigen Vaccine Biologics Corp
  • Wei-Cheng Lian; Meidgen Vaccine Biologics Corp
  • Kuan-Ying A Huang; Chang Gung University
  • Charles Chen; Medigen Vaccine Biologics Corp
Preprint in En | PREPRINT-MEDRXIV | ID: ppmedrxiv-22279317
ABSTRACT
BackgroundThe use of variant-based severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine as a booster is being evaluated to overcome reduced neutralisation of variants induced by the original SARS-CoV-2 vaccine and waning protection over time. MethodsThis is a phase one, prospective, randomized, and open-labeled trial to study the safety and immunogenicity of a booster dose consisting of a subunit vaccine based on the stabilized prefusion SARS-CoV-2 spike protein, MVC-COV1901 or its Beta version, MVC-COV1901-Beta. One-hundred and seven participants aged [≥]18 and <55 years, who received two or three prior doses of MVC-COV1901 vaccines, were enrolled and were to receive a booster dose of either 15 mcg of MVC-COV1901, 15 mcg or 25 mcg of MVC-COV1901-Beta in 111 ratio. The primary endpoints were the incidences of adverse events and immunogenicity of the booster dose from Visit 2 (the day of the booster) to Visit 5 (four weeks after the booster). Cellular immunity was also investigated with memory B cell (MBC) and T cell assays. FindingsAdverse reactions after either MVC-COV1901 or MVC-COV1901-Beta booster doses after two or three doses of MVC-COV1901 were comparable and mostly mild and transient. At four weeks after the booster dose, participants with two prior doses of MVC-COV1901 exhibited numerically higher levels of neutralising antibodies against SARS-CoV-2 or Beta variant than participants with three prior doses of MVC-COV1901 regardless of the type of booster used. However, compared to 15 mcg of MVC-COV1901, 25 mcg of MVC-COV1901-Beta significantly improved neutralising antibody titre against Beta variant and BA.4/BA.5 Omicron variant pseudoviruses. The booster dose also significantly increased the proportion of spike-specific MBCs, including those of Beta and Omicron variants. InterpretationMVC-COV1901-Beta can be effectively used as a booster dose against SARS-CoV-2, including the circulating BA.4/BA.5 Omicron variant. FundingMedigen Vaccine Biologics Corporation
License
cc_by_nc_nd
Full text: 1 Collection: 09-preprints Database: PREPRINT-MEDRXIV Type of study: Experimental_studies / Observational_studies / Prognostic_studies / Rct Language: En Year: 2022 Document type: Preprint
Full text: 1 Collection: 09-preprints Database: PREPRINT-MEDRXIV Type of study: Experimental_studies / Observational_studies / Prognostic_studies / Rct Language: En Year: 2022 Document type: Preprint