Comparable safety and non‑inferior immunogenicity of the SARS‑CoV‑2 mRNA vaccine candidate PTX‑COVID19‑B and BNT162b2 in a phase 2 randomized, observer‑blinded study

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dc.contributor.authorMadhi, Shabir A.
dc.contributor.authorTran, Richard
dc.contributor.authorMartin‑Orozco, Natalia
dc.contributor.authorPanicker, Rajesh Krishnan Gopalakrishna
dc.contributor.authorPastrak, Aleksandra
dc.contributor.authorReiter, Lawrence
dc.contributor.authorGrefrath, Johann
dc.contributor.authorZidel, Bian
dc.contributor.authorOstrowski, Mario
dc.contributor.authorGommerman, Jennifer
dc.contributor.authorCooper, Curtis
dc.date.accessioned2024-11-22T13:15:44Z
dc.date.available2024-11-22T13:15:44Z
dc.date.issued2024
dc.description.abstractIn the aftermath of the COVID-19 pandemic, the evolution of the SARS-CoV-2 into a seasonal pathogen along with the emergence of new variants, underscores the need for dynamic and adaptable responses, emphasizing the importance of sustained vaccination strategies. This observer-blind, double-dummy, randomized immunobridging phase 2 study (NCT05175742) aimed to compare the immunogenicity induced by two doses of 40 μg PTX-COVID19-B vaccine candidate administered 28 days apart, with the response induced by two doses of 30 µg Pfzer-BioNTech COVID-19 vaccine (BNT162b2), administered 21 days apart, in Nucleocapsid-protein seronegative adults 18–64 years of age. Both vaccines were administrated via intramuscular injection in the deltoid muscle. Two weeks after the second dose, the neutralizing antibody (NAb) geometric mean titer ratio and seroconversion rate met the non-inferiority criteria, successfully achieving the primary immunogenicity endpoints of the study. PTX-COVID19-B demonstrated similar safety and tolerability profle to BNT162b2 vaccine. The lowest NAb response was observed in subjects with low-to-undetectable NAb at baseline or no reported breakthrough infection. Conversely, participants who experienced breakthrough infections during the study exhibited higher NAb titers. This study also shows induction of cell-mediated immune (CMI) responses by PTX-COVID19-B. In conclusion, the vaccine candidate PTX-COVID19-B demonstrated favourable safety profle along with immunogenicity similar to the active comparator BNT162b2 vaccine.
dc.description.submitterPM2024
dc.facultyFaculty of Health Sciences
dc.identifier0000-0002-7629-0636
dc.identifier.citationReiter, L., Greffrath, J., Zidel, B. et al. Comparable safety and non-inferior immunogenicity of the SARS-CoV-2 mRNA vaccine candidate PTX-COVID19-B and BNT162b2 in a phase 2 randomized, observer-blinded study. Sci Rep 14, 5365 (2024). https://doi.org/10.1038/s41598-024-55320-1
dc.identifier.issn2045-2322 (online)
dc.identifier.other10.1038/s41598-024-55320-1
dc.identifier.urihttps://hdl.handle.net/10539/42846
dc.journal.titleScientific Reports
dc.language.isoen
dc.publisherNature Research
dc.relation.ispartofseriesVol. 14; a5365
dc.rights© 2024 The Authors. Open Access, This article is licensed under a Creative Commons Attribution 4.0 International License.
dc.schoolSchool of Public Health
dc.subjectDiseases
dc.subjectDrug discovery
dc.subjectImmunology
dc.subject.otherSDG-3: Good health and well-being
dc.titleComparable safety and non‑inferior immunogenicity of the SARS‑CoV‑2 mRNA vaccine candidate PTX‑COVID19‑B and BNT162b2 in a phase 2 randomized, observer‑blinded study
dc.typeArticle
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