V116 Pneumococcal Vaccine Demonstrates Superior Immunogenicity in Japanese Adults 65 and Older
核心洞察
V116, a 21-valent pneumococcal conjugate vaccine, showed non-inferiority to PPSV23 for 12 common serotypes and superiority for nine unique serotypes in vaccine-naïve Japanese adults aged 65 and older.
The phase 3 STRIDE-9 trial enrolled 450 participants and demonstrated comparable safety profiles between V116 and PPSV23, with no vaccine-related serious adverse events or deaths.
V116 elicited immune responses to all included pneumococcal serotypes and the cross-reactive 15B serotype, potentially broadening protection against pneumococcal disease (搜索) in Japan.
V116, a 21-valent pneumococcal conjugate vaccine specifically designed for adults, has demonstrated superior immunogenicity compared to the standard 23-valent pneumococcal polysaccharide vaccine (PPSV23) in vaccine-naïve Japanese adults aged 65 and older, according to results from the phase 3 STRIDE-9 trial published in Vaccine.
The randomized, double-blind, active comparator-controlled study enrolled 450 pneumococcal vaccine-naïve adults aged 65 years and older across eight healthcare centers in Japan between January and May 2023. Participants were randomized 1:1 to receive a single dose of either V116 or PPSV23, with a mean age of 70.7 years across the study population.
Primary Immunogenicity Outcomes Met
V116 achieved its primary immunogenicity objectives, demonstrating non-inferiority to PPSV23 for 12 common serotypes and the cross-reactive serotype 15B based on opsonophagocytic activity (OPA) geometric mean titers at Day 30. More significantly, V116 showed superiority compared to PPSV23 for nine serotypes unique to the vaccine, including serotype 15C.
The vaccine elicited immune responses to all V116 serotypes and the cross-reactive serotype 15B. For the eight unique V116 serotypes, OPA geometric mean titers were numerically higher compared with PPSV23, and the vaccine demonstrated superiority regarding the proportion of participants with a 4-fold or higher increase in OPA from day 1 to day 30.
Comparable Safety Profile
Safety outcomes showed V116 was well-tolerated with a safety profile comparable to PPSV23. While 40% of patients in each vaccine group experienced at least one adverse event (V116: 38.2%; PPSV23: 44.4%), most reported adverse events were mild and included injection-site pain, injection-site erythema, fatigue, and injection-site swelling. Importantly, there were no vaccine-related serious adverse events or deaths in either group.
Addressing Unmet Medical Need
Pneumococcal disease (搜索) prevention remains an unmet medical need in older adults, who constitute a population at heightened risk of severe disease. V116 is specifically designed to provide protection against pneumococcal serotypes associated with a large proportion of residual invasive pneumococcal disease (搜索) (IPD).
The vaccine's design addresses the growing need for enhanced pneumococcal protection in aging populations, particularly relevant in Japan where a large proportion of the population is aged 65 and older. According to the investigators, V116 has the potential to broaden protection against pneumococcal disease (搜索) in Japan through the inclusion of serotypes responsible for the majority of residual pneumococcal disease in adults.
Clinical Implications
These results align with findings from other studies in the STRIDE family of trials, reinforcing V116's robust immunogenicity profile. The vaccine has already been investigated in numerous trials and has become a recommended and approved option for the prevention of serious, invasive disease or pneumonia (搜索) caused by infection with Streptococcus pneumoniae.
The STRIDE-9 findings build upon previous phase 1 trial results conducted among healthy pneumococcal vaccine-naïve Japanese adults aged 20 and older, which demonstrated robust immune responses for all V116 serotypes while eliciting geometric mean titer ratios favorable for protection from the serotypes.
For healthcare professionals globally, these results from the Japanese population provide valuable insights on pneumococcal vaccination strategies for older adults, particularly for populations at the highest risk of serious complications from vaccine-preventable diseases.