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Immunogenicity and Safety of Inactivated Whole Virion Coronavirus Vaccine with Cpg (VLA2001) in Healthy Adults Aged 18 to 55: a Randomised Phase 1 /2 Clinical Trial

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Immunogenicity and Safety of Inactivated Whole Virion Coronavirus Vaccine with Cpg (VLA2001) in Healthy Adults Aged 18 to 55: a Randomised Phase 1 /2 Clinical Trial medRxiv preprint doi: https://doi.org/10.1101/2021.08.13.21262021; this version posted August 20, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . Immunogenicity and safety of inactivated whole virion Coronavirus vaccine with CpG (VLA2001) in healthy adults aged 18 to 55: a randomised phase 1 /2 clinical trial Rajeka Lazarus1*, DPhil; Christian Taucher2* PhD; Claire Brown, BSc3; Irena Corbic, PhD 2 ;Leon Danon4, PhD ; Katrin Dubischar2, MSc ; Christopher J.A. Duncan5 , DPhil; Susanne Eder-Lingelbach 2 MSc ;Prof Saul N Faust6 , PhD; Christopher Green3, DPhil; Karishma Gokani3, MBBS; Romana Hochreiter 2 PhD, Johanna Kellett Wright1, MBBS; Dowan Kwon1, MBChB; Alexander Middleditch1, FFICM; Alasdair P.S. Munro6, MRCPCH; Kush Naker3, MSc; Florentina Penciu1, MD; David Price5, MD ; Benedicte Querton 2 ; Tawassal Riaz1, MBBS; Amy Ross-Russell, MRCP; Amada Sanchez-Gonzalez, MBBS; Hayley Wardle, MB ChB; Sarah Warren, MBBS6 , PhD; Prof Adam Finn,1,7 PhD and the Valneva Phase 1 Trial Group** 1. University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK 2. VALNEVA AUSTRIA GMBH , Vienna, Austria 3. NIHR/Wellcome Trust Clinical Research Facility, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK 4. Department of Engineering Mathematics, University of Bristol, Bristol, UK 5. Department of Infection and Tropical Medicine, Newcastle upon Tyne Hospitals NHS Foundation Trust; Translational and Clinical Research Institute, Immunity and Inflammation Theme, Newcastle, UK NOTE: This preprint reports new research that has not been certified by peer review and should not be used to guide clinical practice. medRxiv preprint doi: https://doi.org/10.1101/2021.08.13.21262021; this version posted August 20, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . 6. NIHR Southampton Clinical Research Facility and NIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust; and Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, UK 7. Schools of Population Health Sciences and Cellular and Molecular Medicine, University of Bristol, Bristol UK Corresponding author: Christian Taucher, [email protected] *Contributed equally Abstract Background We assessed the safety, tolerability and immunogenicity of VLA2001 is a whole-virion inactivated SARS-CoV-2 vaccine adsorbed to alum with a toll-like receptor 9 agonist adjuvant in healthy volunteers aged 18-55. Methods The first 15 participants were enrolled, in groups of 5, to receive two doses, separated by 21 days, of one of three dose concentrations, administered intramuscularly. 138 further participants were randomised 1:1:1 to receive the same 3 dose concentrations, in a double blinded manner. Primary outcomes were solicited adverse reactions 7 days after each vaccination and neutralising antibody geometric mean titres (GMT) against SARS-CoV-2, 2 weeks after the second vaccination (day 36), measured by live microneutralisation assay against wild-type virus (MNA50). Secondary outcomes included unsolicited adverse events, and humoral and cellular responses at day 36, measured by IgG medRxiv preprint doi: https://doi.org/10.1101/2021.08.13.21262021; this version posted August 20, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . ELISA against Spike protein and interferon-γ secreting T-cells by ELISpot stimulated with multiple SARS-CoV-2 antigens. (ClinicalTrials.gov NCT04671017, ISRCTN 82411169) Findings Between December 16, 2020 and January 21, 2021, 153 participants were enrolled and randomised evenly between the dose groups. The rates of solicited reactions were similar after the first and second doses and between the three dose groups. The most frequent local reactions were tenderness (58·2%) and pain (41·8%) and systemic reactions were headache (46%) and fatigue (39·2%). In the high dose group, two weeks following the second dose, the geometric mean titres were 530.4 (95% CI: 421·49, 667·52) for neutralizing antibodies and 2147·9 (95% CI: 1705·98, 2704·22) for S- binding antibodies. There was a dose dependent response with 90·0% (95% CI:78·0%.,97·0%) seroconversion (4-fold rise) at day 36 in the high dose group, which was significantly higher than rates in both the medium (73.5%; 95% CI: 59%,85%), CIs) and low dose (51%; 95%CI: 37%,65%) rate, CIs) groups (both p < 0.001). Antigen-specific interferon-γ T-cells reactive against the S, M and N proteins were observed in 76, 36 and 49% of high dose recipients, respectively. Interpretation VLA2001-201 was well tolerated and produced both humoral and cellular immune responses, with a clear dose-response effect. Funding medRxiv preprint doi: https://doi.org/10.1101/2021.08.13.21262021; this version posted August 20, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . This study was funded by the Department of Health and Social Care, UK The funder had no role in the study design, implementation or analysis. Introduction The COVID-19 pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV- 2) continues to cause considerable mortality and morbidity worldwide.1 Several vaccines against SARS-CoV-2 have been given emergency licenses around the world and millions of individuals have been vaccinated.2 Most of these licensed vaccines induce immunity to the SARS-CoV-2 Spike protein which is the viral protein primarily involved in host receptor recognition, attachment and entry into cells.2 Inactivated vaccines have been used extensively over past decades to provide protection against a number of pathogens. There are 16 inactivated COVID-19 candidate vaccines in clinical evaluation with some already deployed in many countries and administered to millions of people.3 Several studies demonstrate that inactivated vaccines containing aluminium adjuvant induce neutralising antibody responses and have good safety profiles.4-7. A desirable characteristic for any COVID-19 vaccine candidate is the ability to induce T-cell responses. Most whole-virion inactivated vaccines are adjuvanted with alum alone, and induce only limited cell-mediated responses. VLA2001 is a highly purified, inactivated, whole virion, SARS-CoV-2 vaccine, formulated with aluminium hydroxide combined with cytosine phospho-guanine (CpG 1018; Dynavax Technologies Corporation). The immunogenicity of VLA2001 has been demonstrated in murine studies (unpublished data) and was enhanced by the addition of CpG 1018, a toll-like receptor 9 (TLR-9) agonist, stimulating production of innate pro-inflammatory cytokines and a pronounced Th1 medRxiv preprint doi: https://doi.org/10.1101/2021.08.13.21262021; this version posted August 20, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . immune response. This adjuvant has an established safety profile and is contained in a licensed hepatitis B vaccine.8 The aim of the study was to assess safety, reactogenicity and immunogenicity of this novel coronavirus vaccine and to establish the optimal dose to take forward into further clinical development. Methods Study design and participants This report describes results from the first 36 days of follow up, including two weeks after a second dose of vaccine, in an ongoing safety and dose-finding immunogenicity trial. Following an initial open-label dose escalation phase, the second phase of the study had a randomised, double-blind parallel group design with a 1:1:1 allocation to three dose levels. Healthy adult volunteers aged 18- 55 years were recruited either through local advertisement or a national vaccine volunteer registry. All participants were screened with full medical history and physical examination and blood and urine samples were sent to assess HIV, hepatitis B and C, SARS-CoV2 antibodies, full blood count, clotting function, inflammatory markers, liver and renal function and urinary abnormalities (including blood, protein and glucose). All women of childbearing potential had a serum HCG test performed at screening and urine pregnancy tests at all subsequent visits. Subjects with acute febrile or chronic disease, laboratory-confirmed SARS-CoV2 infection or who participated in other SARS- CoV-2 vaccine clinical studies were excluded; for a full list of exclusion criteria refer to supplementary material. medRxiv preprint doi: https://doi.org/10.1101/2021.08.13.21262021; this version posted August 20, 2021. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license . Written informed consent was obtained from all participants, and the trial was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. The study was approved in the UK by the Medicines and Healthcare products Regulatory Agency (43185/0002/001-0001) and the London, Brent ethics committee ref 20/HRA/5205. Randomisation and Blinding The phase 2 study participants were randomly assigned (1:1:1) to receive either the 3AU (low), 7AU (medium) or 35AU (high dose) of VLA2001.
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