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Safety and immunogenicity of the inactivated whole-virus adjuvanted COVID-19 vaccine VLA2001: A randomized, dose escalation, double-blind phase 1/2 clinical trial in healthy adults.
Lazarus, Rajeka; Taucher, Christian; Brown, Claire; Corbic Ramljak, Irena; Danon, Leon; Dubischar, Katrin; Duncan, Christopher J A; Eder-Lingelbach, Susanne; Faust, Saul N; Green, Christopher; Gokani, Karishma; Hochreiter, Romana; Wright, Johanna Kellett; Kwon, Dowan; Middleditch, Alexander; Munro, Alasdair P S; Naker, Kush; Penciu, Florentina; Price, David; Querton, Benedicte; Riaz, Tawassal; Ross-Russell, Amy; Sanchez-Gonzalez, Amada; Wardle, Hayley; Warren, Sarah; Finn, Adam.
  • Lazarus R; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
  • Taucher C; Valneva Austria GmbH, Campus Vienna Biocenter 3, Vienna 1030, Austria. Electronic address: christian.taucher@valneva.com.
  • Brown C; NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Corbic Ramljak I; Valneva Austria GmbH, Campus Vienna Biocenter 3, Vienna 1030, Austria.
  • Danon L; Department of Engineering Mathematics, University of Bristol, Bristol, UK.
  • Dubischar K; Valneva Austria GmbH, Campus Vienna Biocenter 3, Vienna 1030, Austria.
  • Duncan CJA; Department of Infection and Tropical Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Translational and Clinical Research Institute, Immunity and Inflammation Theme, Newcastle, UK.
  • Eder-Lingelbach S; Valneva Austria GmbH, Campus Vienna Biocenter 3, Vienna 1030, Austria.
  • Faust SN; NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.
  • Green C; NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Gokani K; NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Hochreiter R; Valneva Austria GmbH, Campus Vienna Biocenter 3, Vienna 1030, Austria.
  • Wright JK; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
  • Kwon D; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
  • Middleditch A; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
  • Munro APS; NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.
  • Naker K; NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • Penciu F; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
  • Price D; Department of Infection and Tropical Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Translational and Clinical Research Institute, Immunity and Inflammation Theme, Newcastle, UK.
  • Querton B; Valneva Austria GmbH, Campus Vienna Biocenter 3, Vienna 1030, Austria.
  • Riaz T; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK.
  • Ross-Russell A; NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.
  • Sanchez-Gonzalez A; Department of Infection and Tropical Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Translational and Clinical Research Institute, Immunity and Inflammation Theme, Newcastle, UK.
  • Wardle H; Department of Infection and Tropical Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust, Translational and Clinical Research Institute, Immunity and Inflammation Theme, Newcastle, UK.
  • Warren S; NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK.
  • Finn A; University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK; Schools of Population Health Sciences and Cellular and Molecular Medicine, University of Bristol, Bristol, UK.
J Infect ; 85(3): 306-317, 2022 09.
Article in English | MEDLINE | ID: covidwho-1895207
ABSTRACT

OBJECTIVES:

We aimed to evaluate the safety and optimal dose of a novel inactivated whole-virus adjuvanted vaccine against SARS-CoV-2 VLA2001.

METHODS:

We conducted an open-label, dose-escalation study followed by a double-blind randomized trial using low, medium and high doses of VLA2001 (111). The primary safety outcome was the frequency and severity of solicited local and systemic reactions within 7 days after vaccination. The primary immunogenicity outcome was the geometric mean titre (GMT) of neutralizing antibodies against SARS-CoV-2 two weeks after the second vaccination. The study is registered as NCT04671017.

RESULTS:

Between December 16, 2020, and June 3, 2021, 153 healthy adults aged 18-55 years were recruited in the UK. Overall, 81.7% of the participants reported a solicited AE, with injection site tenderness (58.2%) and headache (46.4%) being the most frequent. Only 2 participants reported a severe solicited event. Up to day 106, 131 (85.6%) participants had reported any AE. All observed incidents were transient and non-life threatening in nature. Immunogenicity measured at 2 weeks after completion of the two-dose priming schedule, showed significantly higher GMTs of SARS-CoV-2 neutralizing antibody titres in the highest dose group (GMT 545.6; 95% CI 428.1, 695.4) which were similar to a panel of convalescent sera (GMT 526.9; 95% CI 336.5, 825.1). Seroconversion rates of neutralizing antibodies were also significantly higher in the high-dose group (>90%) compared to the other dose groups. In the high dose group, antigen-specific IFN-γ expressing T-cells reactive against the S, M and N proteins were observed in 76, 36 and 49%, respectively.

CONCLUSIONS:

VLA2001 was well tolerated in all tested dose groups, and no safety signal of concern was identified. The highest dose group showed statistically significantly stronger immunogenicity with similar tolerability and safety, and was selected for phase 3 clinical development.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans Language: English Journal: J Infect Year: 2022 Document Type: Article Affiliation country: J.jinf.2022.06.009

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines Limits: Adult / Humans Language: English Journal: J Infect Year: 2022 Document Type: Article Affiliation country: J.jinf.2022.06.009