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September 7, 2022

Vaxcyte concludes subject enrolment in Phase II pneumococcal vaccine trial

The trial will assess the safety, tolerability, and immunogenicity of VAX-24 in adults aged 65 years and older.

Vaxcyte has concluded subject enrolment in the Phase II clinical trial of investigational vaccine, VAX-24, in healthy adults aged 65 years and above for the prevention of invasive pneumococcal disease (IPD).

Nearly 200 subjects were enrolled at 19 US sites in the trial.

The observer-blind, controlled, randomised, dose-finding trial will assess the safety, tolerability, and immunogenicity of VAX-24 in adults aged 65 years and older.

In the trial, a single injectable dose of VAX-24 will be administered at three dose levels and analysed against Prevnar 20.

Evaluating antibody response induction using OPA and IgG, at three dose levels of VAX-24, as well as against Prevnar 20, will be included as the trial’s prespecified immunogenicity endpoints.

The antibody response for the extra four serotypes in VAX-24 and Pneumovax 23, but not present in Prevnar 20, and the percentage of participants with a four-fold increase in antibody titers will also be analysed.

Following dosing, the trial subjects will also be assessed for six months for safety.

A 24-valent pneumococcal conjugate vaccine (PCV) candidate of the company, VAX-24 can potentially offer broad-spectrum protection for IPD prevention.

In August this year, the vaccine received Fast Track Designation from the US Food and Drug Administration (FDA ) for use in adults.

Vaxcyte CEO and co-founder Grant Pickering said: “Completing the enrolment of the VAX-24 study in adults 65 years and older is a significant step toward understanding the full clinical potential of our lead vaccine candidate in adults.

“We are very pleased with the progress made to advance the VAX-24 clinical programme and we remain on track to announce the topline data from the VAX-24 Phase I/II study in adults 18-64 years of age in October or November of this year, as well as the topline data from the study in adults 65 and older in the first half of 2023.”

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