Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine

Summary

Dosage-Escalation Study to Evaluate the Safety and Immunogenicity of an Aluminium Hydroxide/LHD153R Adjuvanted Meningococcal C-CRM197 Conjugate Vaccine in Healthy Adults (18-45 years of age).

Timeline

Start

2016-03-01

Primary completion

2017-08-31

Completion

2017-08-31

Publications

• Siena E, Schiavetti F, Borgogni E, Taccone M, Faenzi E, Brazzoli M, Aprea S, Bardelli M, Volpini G, Buricchi F, Sammicheli C, Tavarini S, Bechtold V, Blohmke CJ, Cardamone D, De Intinis C, Gonzalez-Lopez A, O'Hagan DT, Nuti S, Seidl C, Didierlaurent AM, Bertholet S, D'Oro U, Medini D, Finco O. Systems analysis of human responses to an aluminium hydroxide-adsorbed TLR7 agonist (AS37) adjuvanted vaccine reveals a dose-dependent and specific activation of the interferon-mediated antiviral response. Vaccine. 2023 Jan 16;41(3):724-734. doi: 10.1016/j.vaccine.2022.12.006. Epub 2022 Dec 21.
• Gonzalez-Lopez A, Oostendorp J, Koernicke T, Fadini T, D'Oro U, Baker S, O'Hagan DT, Del Giudice G, Siena E, Finco O, Medini D. Adjuvant effect of TLR7 agonist adsorbed on aluminum hydroxide (AS37): A phase I randomized, dose escalation study of an AS37-adjuvanted meningococcal C conjugated vaccine. Clin Immunol. 2019 Dec;209:108275. doi: 10.1016/j.clim.2019.108275. Epub 2019 Oct 24.

Drugs

Indications