Safety, Tolerability, and Immunogenicity Study of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Older Adults

Phase 2 Completed 207 enrolled Vaxcyte, Inc.

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The objective of the study is to evaluate the safety and tolerability of a single injection of VAX-24 at 3 dose levels compared to Prevnar 20™ (PCV20) in adults 65 years of age and older.

Timeline

Start: 2022-06-15
Primary completion: 2023-02-15
Completion: 2023-02-15

Publications

Results Wassil J, Sisti M, Fairman J, Rankin B, Clark J, Bennett S, Johnson D, Migone TS, Nguyen K, Paschenko A, Sauer P, Iki S, Hanson ME, Simon JK. A phase 2, randomized, blinded, dose-finding, controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults 65 years and older. Vaccine. 2024 Nov 14;42(25):126124. doi: 10.1016/j.vaccine.2024.07.025. Epub 2024 Jul 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	PCV20	Vaccine	0.5 ml	Intramuscular
Subject	VAX-24	Vaccine	1.1 ug	Intramuscular
Subject	VAX-24	Vaccine	2.2 ug	Intramuscular
Subject	VAX-24	Vaccine	4.4 ug	Intramuscular
Subject	VAX-24	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.