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

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

Outcome

Mixed primary results

release “In the Phase 2 study in adults aged 65 and older, VAX-24 demonstrated robust OPA immune responses for all 24 serotypes at all doses studied.” vaxcyte.com ↗

release “Met the OPA response non-inferiority criteria ( 1) for 18 of 20 STs common with PCV20” vaxcyte.com ↗

release “The two STs that did not reach the OPA response criteria had GMRs of 0.86 (15B) and 0.71 (22F).” vaxcyte.com ↗

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	Prevnar 20	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.