Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine
OVX836 is a recombinant protein-based vaccine targeting the highly conserved influenza nucleoprotein (NP), which aims to confer a broad-spectrum protection against influenza. In a Phase 1 study, OVX836, administered intramuscularly, has been found safe and immunogenic. The 90µg and 180µg dose levels...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-04-01
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| Series: | Frontiers in Immunology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fimmu.2022.852904/full |
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| author | Isabel Leroux-Roels Gwenn Waerlop Jessika Tourneur Fien De Boever Catherine Maes Jacques Bruhwyler Delphine Guyon-Gellin Philippe Moris Judith Del Campo Paul Willems Geert Leroux-Roels Alexandre Le Vert Florence Nicolas |
| author_facet | Isabel Leroux-Roels Gwenn Waerlop Jessika Tourneur Fien De Boever Catherine Maes Jacques Bruhwyler Delphine Guyon-Gellin Philippe Moris Judith Del Campo Paul Willems Geert Leroux-Roels Alexandre Le Vert Florence Nicolas |
| author_sort | Isabel Leroux-Roels |
| collection | DOAJ |
| description | OVX836 is a recombinant protein-based vaccine targeting the highly conserved influenza nucleoprotein (NP), which aims to confer a broad-spectrum protection against influenza. In a Phase 1 study, OVX836, administered intramuscularly, has been found safe and immunogenic. The 90µg and 180µg dose levels were selected to be further evaluated in this randomized, monocenter, reference-controlled (Influvac Tetra™: quadrivalent seasonal influenza subunit vaccine), parallel group, double-blind, Phase 2a study in 300 healthy volunteers, aged 18-65 years, during the 2019/2020 flu season. Safety, influenza-like illness episodes (ILI; based on the Flu-PRO® questionnaire) and immunogenicity were assessed up to 180 days post-vaccination. OVX836 was safe and presented a reactogenicity profile similar to Influvac Tetra. It induced a significant increase in terms of NP-specific interferon-gamma (IFNγ) spot forming cells (SFCs), NP-specific CD4+ T-cells (essentially polyfunctional cells) and anti-NP IgG responses. OVX836 was superior to Influvac Tetra for all immunological parameters related to NP, and the 180µg dose was significantly superior to the 90µg dose for SFCs and CD4+ T-cells expressing IFNγ. Both the CD4+ T-cell and the anti-NP IgG responses persisted up to Day 180. An efficacy signal was observed with OVX836 at 180µg through reduction of ILI episodes occurring during the flu season as of 14 days post-vaccination. In conclusion, these results encourage further clinical evaluation of OVX836 in order to confirm the signal of efficacy on ILIs and/or laboratory-confirmed influenza cases. NCT04192500 (https://clinicaltrials.gov/ct2/show/study/NCT04192500) |
| first_indexed | 2024-04-13T10:47:19Z |
| format | Article |
| id | doaj.art-de7bec781d7f495881521c0c9f132984 |
| institution | Directory Open Access Journal |
| issn | 1664-3224 |
| language | English |
| last_indexed | 2024-04-13T10:47:19Z |
| publishDate | 2022-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Immunology |
| spelling | doaj.art-de7bec781d7f495881521c0c9f1329842022-12-22T02:49:45ZengFrontiers Media S.A.Frontiers in Immunology1664-32242022-04-011310.3389/fimmu.2022.852904852904Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza VaccineIsabel Leroux-Roels0Gwenn Waerlop1Jessika Tourneur2Fien De Boever3Catherine Maes4Jacques Bruhwyler5Delphine Guyon-Gellin6Philippe Moris7Judith Del Campo8Paul Willems9Geert Leroux-Roels10Alexandre Le Vert11Florence Nicolas12Center for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, BelgiumCenter for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, BelgiumOSIVAX, Lyon, FranceCenter for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, BelgiumCenter for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, BelgiumOSIVAX, Lyon, FranceOSIVAX, Lyon, FranceOSIVAX, Lyon, FranceOSIVAX, Lyon, FranceOSIVAX, Lyon, FranceCenter for Vaccinology (CEVAC), Ghent University and University Hospital, Ghent, BelgiumOSIVAX, Lyon, FranceOSIVAX, Lyon, FranceOVX836 is a recombinant protein-based vaccine targeting the highly conserved influenza nucleoprotein (NP), which aims to confer a broad-spectrum protection against influenza. In a Phase 1 study, OVX836, administered intramuscularly, has been found safe and immunogenic. The 90µg and 180µg dose levels were selected to be further evaluated in this randomized, monocenter, reference-controlled (Influvac Tetra™: quadrivalent seasonal influenza subunit vaccine), parallel group, double-blind, Phase 2a study in 300 healthy volunteers, aged 18-65 years, during the 2019/2020 flu season. Safety, influenza-like illness episodes (ILI; based on the Flu-PRO® questionnaire) and immunogenicity were assessed up to 180 days post-vaccination. OVX836 was safe and presented a reactogenicity profile similar to Influvac Tetra. It induced a significant increase in terms of NP-specific interferon-gamma (IFNγ) spot forming cells (SFCs), NP-specific CD4+ T-cells (essentially polyfunctional cells) and anti-NP IgG responses. OVX836 was superior to Influvac Tetra for all immunological parameters related to NP, and the 180µg dose was significantly superior to the 90µg dose for SFCs and CD4+ T-cells expressing IFNγ. Both the CD4+ T-cell and the anti-NP IgG responses persisted up to Day 180. An efficacy signal was observed with OVX836 at 180µg through reduction of ILI episodes occurring during the flu season as of 14 days post-vaccination. In conclusion, these results encourage further clinical evaluation of OVX836 in order to confirm the signal of efficacy on ILIs and/or laboratory-confirmed influenza cases. NCT04192500 (https://clinicaltrials.gov/ct2/show/study/NCT04192500)https://www.frontiersin.org/articles/10.3389/fimmu.2022.852904/fullinfluenzauniversal vaccinenucleoproteinsubunitOVX836Influvac Tetra |
| spellingShingle | Isabel Leroux-Roels Gwenn Waerlop Jessika Tourneur Fien De Boever Catherine Maes Jacques Bruhwyler Delphine Guyon-Gellin Philippe Moris Judith Del Campo Paul Willems Geert Leroux-Roels Alexandre Le Vert Florence Nicolas Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine Frontiers in Immunology influenza universal vaccine nucleoprotein subunit OVX836 Influvac Tetra |
| title | Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine |
| title_full | Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine |
| title_fullStr | Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine |
| title_full_unstemmed | Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine |
| title_short | Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine |
| title_sort | randomized double blind reference controlled phase 2a study evaluating the immunogenicity and safety of ovx836 a nucleoprotein based influenza vaccine |
| topic | influenza universal vaccine nucleoprotein subunit OVX836 Influvac Tetra |
| url | https://www.frontiersin.org/articles/10.3389/fimmu.2022.852904/full |
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