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

Phase 1/2 Completed 835 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 18 to 49 years of age in Phase 1. The Phase 2 will evaluate the safety, tolerability, and immunogenicity of a single injection of VAX-24 at 3 dose levels compared to PCV20 in adults aged 50 to 64 years of age in Phase 2.

Timeline

Start: 2022-02-22
Primary completion: 2023-01-10
Completion: 2023-01-10

Publications

Results Wassil J, Sisti M, Fairman J, Davis M, Fierro C, Bennett S, Johnson D, Migone TS, Nguyen K, Sauer P, Currie M, Iki S, Simon JK. Evaluating the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults aged 18 to 64 years: a phase 1/2, double-masked, dose-finding, active-controlled, randomised clinical trial. Lancet Infect Dis. 2024 Mar;24(3):308-318. doi: 10.1016/S1473-3099(23)00572-8. Epub 2023 Dec 4.

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

Indications

No indication recorded.