VAXNEUVANCE Delivered Robust Immunogenicity Against Key Disease-Causing Serotypes

VAXNEUVANCE Delivered Robust Immunogenicity Against Key Disease-Causing Serotypes

Immunogenicity is the capacity of a vaccine to elicit a measurable immune response.⁵ Clinical trials of VAXNEUVANCE assessed immune response, based on OPA against S. pneumoniae serotypes, as a surrogate measure of protection against invasive pneumococcal disease.

VAXNEUVANCE demonstrated a strong immune response to 15 serotypes, including noninferior immune responses vs PCV13 for the 13 shared serotypes.

Serotypes 22F and 33F are included in VAXNEUVANCE but not in PCV13.

VAXNEUVANCE demonstrated superior immune response vs PCV13 for serotype 3, the leading cause of adult IPD in the United States.³

Comparative OPA GMTs for Serotype 3

GMT Ratio: 1.62 (95% CI: 1.40-1.87)

Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.

Design

Study 1 assessed serotype-specific OPA responses for each of the 15 serotypes contained in VAXNEUVANCE at 30 days postvaccination in a double-blind, active comparator-controlled study that enrolled pneumococcal vaccine–naïve participants 50 years of age and older. Participants were randomized to receive either VAXNEUVANCE (N=604) or PCV13 (N=601) at sites in the United States, Canada, Spain, Taiwan, and Japan. The mean age of participants was 66 years and 57.3% were female. The racial distribution was as follows: 67.7% were White, 25.1% were Asian, 6.1% were Black or African American, and 22.0% were of Hispanic or Latino ethnicity.

CI, confidence interval; GMT, geometric mean titer; IPD, invasive pneumococcal disease; OPA, opsonophagocytic activity; PCV13, 13-valent pneumococcal conjugate vaccine.