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Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVC-COV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study.
Hsieh, Szu-Min; Liu, Wang-Da; Huang, Yu-Shan; Lin, Yi-Jiun; Hsieh, Erh-Fang; Lian, Wei-Cheng; Chen, Charles; Janssen, Robert; Shih, Shin-Ru; Huang, Chung-Guei; Tai, I-Chen; Chang, Shan-Chwen.
  • Hsieh SM; Section of Infectious Diseases, Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, National Taiwan University, Taiwan.
  • Liu WD; Section of Infectious Diseases, Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, National Taiwan University, Taiwan.
  • Huang YS; Section of Infectious Diseases, Division of Infectious Diseases, Department of Internal Medicine, National Taiwan University Hospital and College of Medicine, National Taiwan University, Taiwan.
  • Lin YJ; Medigen Vaccine Biologics Corp., Taiwan.
  • Hsieh EF; Medigen Vaccine Biologics Corp., Taiwan.
  • Lian WC; Medigen Vaccine Biologics Corp., Taiwan.
  • Chen C; Medigen Vaccine Biologics Corp., Taiwan.
  • Janssen R; College of Science and Technology, Temple University, Philadelphia, PA 19122, U.S.A.
  • Shih SR; Dynavax Technologies Corporation, Emeryville, CA 94608, U.S.A.
  • Huang CG; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung University, Taoyuan City, Taiwan.
  • Tai IC; Research Center for Emerging Viral Infections, College of Medicine, Chang Gung University, Taoyuan City, Taiwan.
  • Chang SC; Department of Laboratory Medicine, Linkou Chang Gung Memorial Hospital, Taoyuan City, Taiwan.
EClinicalMedicine ; 38: 100989, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1375926
ABSTRACT

BACKGROUND:

This was a phase 1, dose-escalation open-label trial to evaluate the safety and immunogenicity of MVC-COV1901, a SARS-CoV-2 S-2P protein vaccine adjuvanted with aluminum hydroxide and CpG 1018.

METHODS:

Between September 28 and November 13 2020, 77 participants were screened. Of these, 45 healthy adults from 20 to 49 years of age were to be administered two doses of MVC-COV1901 in doses of 5 µg, 15 µg, or 25 µg of spike protein at 28 days apart. There were 15 participants in each dose group; all were followed for 28 days after the second dose at the time of the interim analysis. Adverse events and laboratory data were recorded for the safety evaluation. Blood samples were collected for humoral, and cellular immune response at various time points. Trial Registration ClinicalTrials.gov NCT04487210.

FINDINGS:

Solicited adverse events were mostly mild and similar. No subject experienced fever. After the second dose, the geometric mean titers (GMTs) for SARS-CoV-2 spike-specific immunoglobulin G were 7178.2, 7746.1, 11,220.6 in the 5 µg, 15 µg, and 25 µg dose groups, respectively. The neutralizing activity were detected in both methods. (Day 43 GMTs, 538.5, 993.1, and 1905.8 for pseudovirus; and 33.3, 76.3, and 167.4 for wild-type virus). The cellular immune response induced by MVC-COV1901 demonstrated substantially higher numbers of IFN-γ- producing cells, suggesting a Th1-skewed immune response.

INTERPRETATION:

The MVC-COV1901 vaccine was well tolerated and elicited robust immune responses and is suitable for further development.

FUNDING:

Medigen Vaccine Biologics Corporation.

Full text: Available Collection: International databases Database: MEDLINE Type of study: Randomized controlled trials Topics: Vaccines Language: English Journal: EClinicalMedicine Year: 2021 Document Type: Article Affiliation country: J.eclinm.2021.100989

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Randomized controlled trials Topics: Vaccines Language: English Journal: EClinicalMedicine Year: 2021 Document Type: Article Affiliation country: J.eclinm.2021.100989