Merck's Investigational 21-Valent Pneumococcal Conjugate Vaccine V116 Shows Positive Phase 3 Results in Adults

▎WuXi

Edited by Kant Content Team

MSD announced positive results from the Phase 3 trial STRIDE-3 today. The trial evaluated the immunogenicity, tolerability, and safety of its investigational 21-valent pneumococcal conjugate vaccine V116 compared to an active comparator vaccine in adults who had not previously received a pneumococcal vaccine.According to the press release, MSD will submit the trial results to global regulatory authorities, and if approved, V116 will become the first pneumococcal conjugate vaccine specifically designed for adults.Detailed results of the STRIDE-3 trial will be announced at the upcoming World Vaccine Congress West Coast.

The analysis of the primary endpoint of the trial showed that, based on the measurement of serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) on day 30, in adults aged 50 years and older (Cohort 1),In all 10 serotypes shared between V116 and the active control vaccine PCV20 (Pneumococcal 20-valent Conjugate Vaccine), the immune response elicited by V116 demonstrated non-inferiority.Based on the measurement results of OPA GMT on Day 30 and the proportion of patients with an OPA increase ≥4 times from Day 1 to Day 30,Of the 11 serotypes contained in V116, 10 demonstrated a good immune response, while the active control vaccine did not contain these.11 Serotypes。Moreover, based on the evaluation of serotype-specific OPAGMTs 30 days post-vaccination, the immune response induced by V116 in adults aged 18-49 (Cohort 2) demonstrated non-inferiority compared to adults aged 50-64.

In both cohorts, the safety profile of V116 was comparable to that of the active control group.

Image Source: 123RF

V116 is an investigational 21-valent pneumococcal conjugate vaccine.V116 is specifically designed to address the main serotypes of Streptococcus pneumoniae that cause pneumococcal disease in adults, including eight unique serotypes: 15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B.According to the 2018-2021 data from the U.S. Centers for Disease Control and Prevention (CDC), these serotypes account for approximately 30% of adult diseases.According to the same CDC data,The serotypes covered by V116 account for approximately 83% of patients aged 65 and above with invasive pneumococcal disease.

[1] Merck’s V116, an Investigational, 21-valent PneumococcalConjugate Vaccine Specifically Designed to Protect Adults, DemonstratedSuperior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20 inAdults 50 Years of Age and Older. Retrieved November 28, 2023 from https://www.merck.com/news/mercks-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-to-protect-adults-demonstrated-superior-immunogenicity-for-10-of-11-unique-serotypes-compared/

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