Single Ascending Dose of ASP3772 Study in Japanese Healthy Male and Female Adults, and Single Ascending Dose Study of ASP3772 in Comparison With PPSV23 in Japanese Elderly Male and Female Subjects

Phase 1 Completed 126 enrolled Affinivax, Inc.

RandomizedSequentialQuadruple-blindPrevention

Summary

The purpose of this study is to evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly to Japanese healthy adults 20 to 49 years of age. This study will also evaluate the safety and tolerability of 3 different dose levels of ASP3772 administered subcutaneously or intramuscularly, in comparison to the active comparator 23-valent pneumococcal polysaccharide vaccine (PPSV23) in Japanese elderly subjects 65 to 85 years of age.

Timeline

Start: 2020-02-19
Primary completion: 2020-11-07
Completion: 2020-11-07

Publications

Borys D, Smulders R, Haranaka M, Nakano T, Chichili GR, Ebara M, Hashimoto A, Iwahana M, Oizumi Y, Nanra J, Malley R, Sebastian S. Safety, reactogenicity, and immunogenicity of a novel 24-valent pneumococcal vaccine candidate in healthy, pneumococcal vaccine-naive Japanese adults: A phase 1 randomized dose-escalation trial. Vaccine. 2025 Jan 12;44:126545. doi: 10.1016/j.vaccine.2024.126545. Epub 2024 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP3772	Vaccine	1 ug	Subcutaneous
Subject	ASP3772	Vaccine	2 ug	Subcutaneous
Subject	ASP3772	Vaccine	5 ug	Subcutaneous
Comparator	Pneumovax 23	Vaccine	—	Subcutaneous

Indications

No indication recorded.