Vaccine maker Vaxcyte this week introduced constructive topline outcomes from a part 3 trial of its investigational 31-valent (31-strain) pneumococcal conjugate vaccine (PCV) candidate, VAX-31.
VAX-31 was designed to forestall severe and generally deadly infections brought on by Streptococcus pneumoniae, together with invasive pneumococcal illness IPD and pneumococcal pneumonia. The 31 serotypes coated by the vaccine account for about 95% of IPD and 88% of pneumococcal pneumonia instances circulating in adults age 50 and older.
PCVs are beneficial by the Facilities for Illness Management and Prevention for adults aged 50 and older who haven’t beforehand acquired one, kids beneath 5 years, and older kids and adults with sure danger situations. The 4 PCVs accredited in the US are PCV15, PCV20, PCV21, and the pneumococcal polysaccharide vaccine (PPSV23).
The OPUS-1 trial evaluated the protection, tolerability, and immunogenicity of a excessive dose of VAX-31 in 3,572 adults aged 50 and older and a decrease dose in 475 adults aged 18 to 49 years. Members aged 50 and older had been randomized 1:1:1 to obtain VAX-31 or PCV20 or PCV21, whereas youthful members had been randomized 3:1 to obtain a single dose of VAX-31 or PCV20.
Comparable immune response, security profile
Vaxcyte mentioned VAX-31 was nicely tolerated and demonstrated an analogous security profile to PCV20 and PCV21 in all age-groups, with typically mild-to-moderate native and systemic reactions and no severe hostile occasions.
In adults 50 and older, VAX-31 confirmed a comparable immune response throughout all 28 serotypes shared with PCV20 and PCV21 and met prespecified noninferiority standards for immunogenicity; the three serotypes distinctive to VAX-31 met the prevalence criterion. In adults aged 18 to 49, VAX-31 elicited an immune response just like older adults.
“These OPUS-1 outcomes strengthen our confidence in VAX-31’s potential to offer broader safety in opposition to invasive pneumococcal illness and pneumococcal pneumonia,” James Wassil, MS, MBA, Vaxcyte’s chief scientific officer and chief working officer, mentioned in an organization press launch.
Vacxyte mentioned the outcomes would be the “cornerstone” of a biologics license utility to the US Meals and Drug Administration, together with outcomes from two different trials, OPUS-2 and OPUS-3, that are anticipated subsequent yr.
