Safety and Immunogenicity of CpG 1018 and Aluminium Hydroxide-Adjuvanted SARS-CoV-2 S-2P Protein Vaccine MVC-COV1901: A Large-Scale Double-Blind, Randomised, Placebo-Controlled Phase 2 Trial
Genre
Pre-printDate
2021-08-08Author
Szu-Min, HsiehLiu, Ming-Che
Chen, Yen-Hsu
Lee, Wen-Sen
Hwang, Shinn-Jang
Cheng, Shu-Hsing
Ko, Wen-Chien
Hwang, Kao-Pin
Wang, Ning-Chi
Lee, Yu-Lin
Lin, Yi-Ling
Shih, Shin-Ru
Huang, Chung-Guei
Liao, Chun-Che
Liang, Jian-Jong
Chang, Chih-Shin
Chen, Charles
Lien, Chia En
Tai, I-Chen
Lin, Tzou-Yien
Department
BiologySubject
Infectious DiseasesBinding antibody units (BAU)
Correlates of Protection (CoP)
COVID-19
Vaccine
International unit (IU)
Recombinant protein subunit vaccine
S-2P prefusion
Protein
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http://hdl.handle.net/20.500.12613/6985
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https://doi.org/10.1101/2021.08.05.21261532Abstract
Background: We have assessed the safety and immunogenicity of the COVID-19 vaccine MVC-COV1901, a recombinant protein vaccine containing prefusion-stabilized spike protein S-2P adjuvanted with CpG 1018 and aluminium hydroxide. Methods: This is a phase 2, prospective, randomised, double-blind, placebo-controlled, and multi-centre study to evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 vaccine candidate MVC-COV1901. The study comprised 3,844 participants of ≥ 20 years who were generally healthy or with stable pre-existing medical conditions. The study participants were randomly assigned in a 6:1 ratio to receive either MVC-COV1901 containing 15 μg of S-2P protein or placebo containing saline. Participants received two doses of MVC-COV1901 or placebo, administered 28 days apart via intramuscular injection. The primary outcomes were to evaluate the safety, tolerability, and immunogenicity of MVC-COV1901 from Day 1 (the day of first vaccination) to Day 57 (28 days after the second dose). Immunogenicity of MVC-COV1901 was assessed through geometric mean titres (GMT) and seroconversion rates (SCR) of neutralising antibody and antigen-specific immunoglobulin. This clinical trial is registered at ClinicalTrials.gov: NCT04695652. Findings: From the start of this phase 2 trial to the time of interim analysis, no vaccine-related Serious Adverse Events (SAEs) were recorded. The most common solicited adverse events across all study participants were pain at the injection site (64%), and malaise/fatigue (35%). Fever was rarely reported (<1%). For all participants in the MVC-COV1901 group, at 28 days after the second dose against wild type SARS-CoV-2 virus, the GMT was 662·3 (408 IU/mL), the GMT ratio was 163·2, and the seroconversion rate was 99·8%. Interpretation: MVC-COV1901 shows good safety profiles and promising immunogenicity responses. The current data supports MVC-COV1901 to enter phase 3 efficacy trials and could enable regulatory considerations for Emergency Use Authorisation (EUA). Funding: Medigen Vaccine Biologics Corporation and Taiwan Centres for Disease Control.Citation to related work
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http://dx.doi.org/10.34944/dspace/6966
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