The investigational PCV is designed to target serotypes responsible for 85% of all invasive cases of the disease in individuals aged 65 and older in the United States.
Merck announced the presentation of positive results from the phase 1/2 study, V116-001, evaluating the immunogenicity, safety, and tolerability of V116, an investigational 21-valent pneumococcal conjugate vaccine (PCV), in pneumococcal vaccine-naïve adults aged 18 to 49 years in phase 1 and aged 50 years or older in phase 2.
“Our encouraging data at [the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12)] reflect the potential of V116 and Merck’s tailored approach to developing pneumococcal vaccines to meet the specific needs of different populations,” Eliav Barr, MD, senior vice president, head of global clinical development, and chief medical officer at Merck Research Laboratories, said in a statement.
“Consistent with our portfolio strategy, V116 is designed to specifically target serotypes that are responsible for 85% of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019. Importantly, the 8 serotypes in V116 that are not included in any currently licensed pneumococcal vaccine account for over 30% of this disease burden alone,” Barr said.
In both populations, the vaccine met the primary immunogenicity objectives and was well-tolerated with an overall safety profile comparable to the Pneumovax 23 (Merck), a pneumococcal vaccine polyvalent, across all age groups.
In the phase 2 study, V116 demonstrated non-inferior immune responses to the Pneumovax 23 for all shared serotypes and superior immune responses for the serotypes included in V116 but not included in Pneumovax 23.
Investigators measured the responses 30 days post-vaccination by serotype-specific opsonophagocytic activity (OPA) geonomics mean titers (GMTs), a measure of functional body activity.
In the phase 1 part of the study, individuals aged 18 to 49 years were randomized 1:1:1: to receive either a single dose of V116-1, a 2-µg dose/each pneumococcal polysaccharide (PnPs), V116-2, a 4-µg dose/each PnPs, or Pneumovax 23.
Investigators found that the immune response at day 30 in V116-1 and V116-2 arms were generally comparable to Pneumovax 23 for the serotypes common to both vaccines. Additionally, the immune response was higher than Pneumovax 23 for the serotypes unique to V116.
At day 30, the OPA GMTs were higher in the V116-2 arm compared with the V116-1 arm for all serotypes except 9N.
The immunogenicity and safety data support the continued development of V116.
In phase 2, adults aged 50 years or older were randomized 1:1, stratified by age groups: aged 50 to 64 years, aged 65 to 74 years, and aged 76 years or older, to received either a single dose of V116 or Pneumovax 23. Pneumococcal serotype specific OPA and immunoglobulin G were measured prior to and 30 days postvaccination. V116 met noninferiority criteria compared with Pneumovax 23 for all shared serotypes and met superior criteria for the unique serotypes based on the assessment of the lower bound of the GMT ratio.
The safety was evaluated based on the proportion of participants with adverse events following vaccination.
Data from V116-001 and other data from Merck’s pneumococcal vaccines portfolio were featured at ISPPD-12, which took place from June 19, 2022, through June 23, 2022. The full study results will be published in a scientific journal.
This year, the FDA granted V116 breakthrough designation for the prevention of invasive pneumococcal disease and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes in adults, including: 3; 6A/C; 7F; 8; 9N; 10A; 11A; 12F; 15A; 15B/C; 16F; 17F; 19A; 20; 22F; 23A; 23B; 24F; 31; 33F; and 35B.
This includes 8 serotypes not included in any licensed pneumococcal vaccine.
Merck presents positive results from phase 1/2 study evaluating V116, the company’s investigational pneumococcal conjugate vaccine for adults. Merck. News release. June 21, 2022. Accessed June 22, 2022. https://www.merck.com/news/merck-presents-positive-results-from-phase-1-2-study-evaluating-v116-the-companys-investigational-pneumococcal-conjugate-vaccine-for-adults/