Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose boosterResearch in context
Summary: Background: SARS-CoV-2 booster vaccination should ideally enhance protection against variants and minimise immune imprinting. This Phase I trial evaluated two vaccines targeting SARS-CoV-2 beta-variant receptor-binding domain (RBD): a recombinant dimeric RBD-human IgG1 Fc-fusion protein, a...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-12-01
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| Series: | EBioMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2352396423004449 |
| _version_ | 1827632018741002240 |
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| author | Terry M. Nolan Georgia Deliyannis Maryanne Griffith Sabine Braat Lilith F. Allen Jennifer Audsley Amy W. Chung Marcin Ciula Nicholas A. Gherardin Michelle L. Giles Tom P. Gordon Samantha L. Grimley Lana Horng David C. Jackson Jennifer A. Juno Katherine Kedzierska Stephen J. Kent Sharon R. Lewin Mason Littlejohn Hayley A. McQuilten Francesca L. Mordant Thi H.O. Nguyen Vanessa Pac Soo Briony Price Damian F.J. Purcell Pradhipa Ramanathan Samuel J. Redmond Steven Rockman Zheng Ruan Joseph Sasadeusz Julie A. Simpson Kanta Subbarao Stewart A. Fabb Thomas J. Payne Asuka Takanashi Chee Wah Tan Joseph Torresi Jing Jing Wang Lin-Fa Wang Hareth Al-Wassiti Chinn Yi Wong Sophie Zaloumis Colin W. Pouton Dale I. Godfrey |
| author_facet | Terry M. Nolan Georgia Deliyannis Maryanne Griffith Sabine Braat Lilith F. Allen Jennifer Audsley Amy W. Chung Marcin Ciula Nicholas A. Gherardin Michelle L. Giles Tom P. Gordon Samantha L. Grimley Lana Horng David C. Jackson Jennifer A. Juno Katherine Kedzierska Stephen J. Kent Sharon R. Lewin Mason Littlejohn Hayley A. McQuilten Francesca L. Mordant Thi H.O. Nguyen Vanessa Pac Soo Briony Price Damian F.J. Purcell Pradhipa Ramanathan Samuel J. Redmond Steven Rockman Zheng Ruan Joseph Sasadeusz Julie A. Simpson Kanta Subbarao Stewart A. Fabb Thomas J. Payne Asuka Takanashi Chee Wah Tan Joseph Torresi Jing Jing Wang Lin-Fa Wang Hareth Al-Wassiti Chinn Yi Wong Sophie Zaloumis Colin W. Pouton Dale I. Godfrey |
| author_sort | Terry M. Nolan |
| collection | DOAJ |
| description | Summary: Background: SARS-CoV-2 booster vaccination should ideally enhance protection against variants and minimise immune imprinting. This Phase I trial evaluated two vaccines targeting SARS-CoV-2 beta-variant receptor-binding domain (RBD): a recombinant dimeric RBD-human IgG1 Fc-fusion protein, and an mRNA encoding a membrane-anchored RBD. Methods: 76 healthy adults aged 18–64 y, previously triple vaccinated with licensed SARS-CoV-2 vaccines, were randomised to receive a 4th dose of either an adjuvanted (MF59®, CSL Seqirus) protein vaccine (5, 15 or 45 μg, N = 32), mRNA vaccine (10, 20, or 50 μg, N = 32), or placebo (saline, N = 12) at least 90 days after a 3rd boost vaccination or SARS-CoV-2 infection. Bleeds occurred on days 1 (prior to vaccination), 8, and 29. ClinicalTrials.gov NCT05272605. Findings: No vaccine-related serious or medically-attended adverse events occurred. The protein vaccine reactogenicity was mild, whereas the mRNA vaccine was moderately reactogenic at higher dose levels. Best anti-RBD antibody responses resulted from the higher doses of each vaccine. A similar pattern was seen with live virus neutralisation and surrogate, and pseudovirus neutralisation assays. Breadth of immune response was demonstrated against BA.5 and more recent omicron subvariants (XBB, XBB.1.5 and BQ.1.1). Binding antibody titres for both vaccines were comparable to those of a licensed bivalent mRNA vaccine. Both vaccines enhanced CD4+ and CD8+ T cell activation. Interpretation: There were no safety concerns and the reactogenicity profile was mild and similar to licensed SARS-CoV-2 vaccines. Both vaccines showed strong immune boosting against beta, ancestral and omicron strains. Funding: Australian Government Medical Research Future Fund, and philanthropies Jack Ma Foundation and IFM investors. |
| first_indexed | 2024-03-09T14:29:49Z |
| format | Article |
| id | doaj.art-759603e2b16e4eff9551a0f453f831d4 |
| institution | Directory Open Access Journal |
| issn | 2352-3964 |
| language | English |
| last_indexed | 2024-03-09T14:29:49Z |
| publishDate | 2023-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EBioMedicine |
| spelling | doaj.art-759603e2b16e4eff9551a0f453f831d42023-11-28T04:06:14ZengElsevierEBioMedicine2352-39642023-12-0198104878Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose boosterResearch in contextTerry M. Nolan0Georgia Deliyannis1Maryanne Griffith2Sabine Braat3Lilith F. Allen4Jennifer Audsley5Amy W. Chung6Marcin Ciula7Nicholas A. Gherardin8Michelle L. Giles9Tom P. Gordon10Samantha L. Grimley11Lana Horng12David C. Jackson13Jennifer A. Juno14Katherine Kedzierska15Stephen J. Kent16Sharon R. Lewin17Mason Littlejohn18Hayley A. McQuilten19Francesca L. Mordant20Thi H.O. Nguyen21Vanessa Pac Soo22Briony Price23Damian F.J. Purcell24Pradhipa Ramanathan25Samuel J. Redmond26Steven Rockman27Zheng Ruan28Joseph Sasadeusz29Julie A. Simpson30Kanta Subbarao31Stewart A. Fabb32Thomas J. Payne33Asuka Takanashi34Chee Wah Tan35Joseph Torresi36Jing Jing Wang37Lin-Fa Wang38Hareth Al-Wassiti39Chinn Yi Wong40Sophie Zaloumis41Colin W. Pouton42Dale I. Godfrey43Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection & Immunity, Melbourne, Australia; Murdoch Children's Research Institute, Melbourne, Australia; Corresponding author. Head, Vaccine and Immunisation Research Group (VIRGo), Peter Doherty Institute for Infection and Immunity, G06/766 Elizabeth St, University of Melbourne, VIC, 3010, Australia.Department of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection & Immunity, Melbourne, AustraliaCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection & Immunity, Melbourne, AustraliaDepartment of Immunology, Flinders University and SA Pathology, Flinders Medical Centre, Bedford Park, Adelaide, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection & Immunity, Melbourne, Australia; Murdoch Children's Research Institute, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia; Global Station for Zoonosis Control, Global Institution for Collaborative Research and Education (GI-CoRE), Hokkaido University, Sapporo, JapanDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection & Immunity, Melbourne, Australia; Victorian Infectious Diseases Service, Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia; Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, AustraliaDepartment of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection & Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, AustraliaDepartment of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection & Immunity, Melbourne, Australia; Murdoch Children's Research Institute, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia; CSL Seqirus, Vaccine Innovation Unit, Parkville, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaVictorian Infectious Diseases Service, Royal Melbourne Hospital at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia; Department of Infectious Diseases, Alfred Hospital and Monash University, Melbourne, AustraliaCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, Australia; WHO Collaborating Centre for Reference and Research on Influenza at the Peter Doherty Institute for Infection and Immunity, AustraliaMonash Institute of Pharmaceutical Sciences, Parkville, AustraliaMonash Institute of Pharmaceutical Sciences, Parkville, AustraliaMonash Institute of Pharmaceutical Sciences, Parkville, AustraliaDuke NUS Medical School, Programme for Emerging Infectious Diseases, SingaporeDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaDepartment of Immunology, Flinders University and SA Pathology, Flinders Medical Centre, Bedford Park, Adelaide, AustraliaDuke NUS Medical School, Programme for Emerging Infectious Diseases, SingaporeMonash Institute of Pharmaceutical Sciences, Parkville, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaCentre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, AustraliaMonash Institute of Pharmaceutical Sciences, Parkville, AustraliaDepartment of Microbiology & Immunology, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Melbourne, AustraliaSummary: Background: SARS-CoV-2 booster vaccination should ideally enhance protection against variants and minimise immune imprinting. This Phase I trial evaluated two vaccines targeting SARS-CoV-2 beta-variant receptor-binding domain (RBD): a recombinant dimeric RBD-human IgG1 Fc-fusion protein, and an mRNA encoding a membrane-anchored RBD. Methods: 76 healthy adults aged 18–64 y, previously triple vaccinated with licensed SARS-CoV-2 vaccines, were randomised to receive a 4th dose of either an adjuvanted (MF59®, CSL Seqirus) protein vaccine (5, 15 or 45 μg, N = 32), mRNA vaccine (10, 20, or 50 μg, N = 32), or placebo (saline, N = 12) at least 90 days after a 3rd boost vaccination or SARS-CoV-2 infection. Bleeds occurred on days 1 (prior to vaccination), 8, and 29. ClinicalTrials.gov NCT05272605. Findings: No vaccine-related serious or medically-attended adverse events occurred. The protein vaccine reactogenicity was mild, whereas the mRNA vaccine was moderately reactogenic at higher dose levels. Best anti-RBD antibody responses resulted from the higher doses of each vaccine. A similar pattern was seen with live virus neutralisation and surrogate, and pseudovirus neutralisation assays. Breadth of immune response was demonstrated against BA.5 and more recent omicron subvariants (XBB, XBB.1.5 and BQ.1.1). Binding antibody titres for both vaccines were comparable to those of a licensed bivalent mRNA vaccine. Both vaccines enhanced CD4+ and CD8+ T cell activation. Interpretation: There were no safety concerns and the reactogenicity profile was mild and similar to licensed SARS-CoV-2 vaccines. Both vaccines showed strong immune boosting against beta, ancestral and omicron strains. Funding: Australian Government Medical Research Future Fund, and philanthropies Jack Ma Foundation and IFM investors.http://www.sciencedirect.com/science/article/pii/S2352396423004449SARS-CoV-2VaccineReceptor binding domainRecombinant proteinmRNABeta variant |
| spellingShingle | Terry M. Nolan Georgia Deliyannis Maryanne Griffith Sabine Braat Lilith F. Allen Jennifer Audsley Amy W. Chung Marcin Ciula Nicholas A. Gherardin Michelle L. Giles Tom P. Gordon Samantha L. Grimley Lana Horng David C. Jackson Jennifer A. Juno Katherine Kedzierska Stephen J. Kent Sharon R. Lewin Mason Littlejohn Hayley A. McQuilten Francesca L. Mordant Thi H.O. Nguyen Vanessa Pac Soo Briony Price Damian F.J. Purcell Pradhipa Ramanathan Samuel J. Redmond Steven Rockman Zheng Ruan Joseph Sasadeusz Julie A. Simpson Kanta Subbarao Stewart A. Fabb Thomas J. Payne Asuka Takanashi Chee Wah Tan Joseph Torresi Jing Jing Wang Lin-Fa Wang Hareth Al-Wassiti Chinn Yi Wong Sophie Zaloumis Colin W. Pouton Dale I. Godfrey Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose boosterResearch in context EBioMedicine SARS-CoV-2 Vaccine Receptor binding domain Recombinant protein mRNA Beta variant |
| title | Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose boosterResearch in context |
| title_full | Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose boosterResearch in context |
| title_fullStr | Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose boosterResearch in context |
| title_full_unstemmed | Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose boosterResearch in context |
| title_short | Interim results from a phase I randomized, placebo-controlled trial of novel SARS-CoV-2 beta variant receptor-binding domain recombinant protein and mRNA vaccines as a 4th dose boosterResearch in context |
| title_sort | interim results from a phase i randomized placebo controlled trial of novel sars cov 2 beta variant receptor binding domain recombinant protein and mrna vaccines as a 4th dose boosterresearch in context |
| topic | SARS-CoV-2 Vaccine Receptor binding domain Recombinant protein mRNA Beta variant |
| url | http://www.sciencedirect.com/science/article/pii/S2352396423004449 |
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