Safety and Humoral Immunogenicity of Different Dose Levels of Ad26.COV2.S as a 2-Dose Regimen in COVID-19 Vaccine-Naïve Healthy Adults: A Phase 3 Randomized Clinical Trial.

Autor:	Rezelj VV; Janssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands., Paddenburg F; Vimef Holding B.V., 3311 GE Dordrech, The Netherlands., Diegbe ME; Janssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands., Nangosyah J; Cytel Global Headquarters, Cambridge, MA 02139, USA., Reisinger EC; Rostock University Medical Center, 18057 Rostock, Germany., Hu W; Cytel Global Headquarters, Cambridge, MA 02139, USA., Truyers C; Janssen Research and Development, 2340 Beerse, Belgium., Scheper G; Janssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands., Le Gars M; Janssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands., Hendriks J; Janssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands., Struyf F; Janssen Research and Development, 2340 Beerse, Belgium., Douoguih M; Janssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands., Schuitemaker H; Janssen Vaccines & Prevention, 2301 CN Leiden, The Netherlands., Ruiz-Guiñazú J; Janssen Research and Development, 2340 Beerse, Belgium.
Jazyk:	angličtina
Zdroj:	Vaccines [Vaccines (Basel)] 2024 Oct 03; Vol. 12 (10). Date of Electronic Publication: 2024 Oct 03.
DOI:	10.3390/vaccines12101136
Abstrakt:	Background: This study aimed to support the end-of-shelf life specification (2.5 × 10 10 virus particles [vp]) for the standard Ad26.COV2.S dose (5 × 10 10 vp). Methods: This randomized, double-blind Phase 3 study evaluated immunogenicity, reactogenicity, and safety of several Ad26.COV2.S dose levels (range 1.25 to 9 × 10 10 vp) in 1593 adults between June 2021 and July 2023. Results: Spike-binding antibody responses 28 days post-dose 1 were non-inferior for the 9 × 10 10 vp, but not the 2.5 × 10 10 vp group when compared with the standard dose. Non-inferiority was demonstrated in terms of spike-binding antibody responses 14 days post-dose 2 for each dose level, including the lowest dose level of 1.25 × 10 10 vp, compared to 28 days after one dose and 14 days after two doses of the standard dose. Spike-binding antibody levels correlated well with virus neutralizing titers. There was no impact of pre-existing Ad26.COV2.S neutralizing titers on immunogenicity at any dose level. All dose levels were well tolerated. Conclusions: This study highlights the challenges associated with conducting clinical studies in a rapidly evolving environment and underscores the importance of platform data that can guide initial vaccine specifications such as shelf life during accelerated vaccine development. The present study supports the end-of-shelf life specifications for the approved Ad26.COV2.S dose, and could provide useful information in future vaccine developments using adenovirus vector vaccines.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu