Rahway: Merck, known as MSD outside the United States and Canada, has announced the presentation of positive results from the Phase 1/2 study, V116-001, evaluating the safety, tolerability and immunogenicity of V116, the company’s investigational 21-valent pneumococcal conjugate vaccine (PCV), in pneumococcal vaccine-naïve adults 18-49 years of age (Phase 1) and 50 years of age and older (Phase 2). In both populations, V116 met the primary immunogenicity objectives and was well-tolerated with an overall safety profile generally comparable to PNEUMOVAX23 (Pneumococcal Vaccine Polyvalent) across age groups. In the Phase 2 part of the study, V116 demonstrated non-inferior immune responses to PNEUMOVAX 23 for all shared serotypes, and superior immune responses for the serotypes included in V116 but not included in PNEUMOVAX 23, based on study-defined criteria. Responses were measured 30 days post-vaccination by serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs), a measure of functional antibody activity.
Data from V116-001, in addition to other data from the company’s pneumococcal vaccines portfolio, are being featured at the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12) taking place in Toronto from June 19-23, 2022. The full study results from V116-001 will be published in a scientific journal in the future.
Earlier this year, V116 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (USFDA) for the prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A/C, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B/C, 16F, 17F, 19A, 20, 22F, 23A, 23B, 24F, 31, 33F, 35B in adults 18 years of age and older. This includes eight serotypes not included in any currently licensed pneumococcal vaccine.
“Our encouraging data at ISPPD reflect the potential of V116 and Merck’s tailored approach to developing pneumococcal vaccines to meet the specific needs of different populations,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “Consistent with our portfolio strategy, V116 is designed to specifically target serotypes that are responsible for 85 percent of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 20191. Importantly, the eight serotypes in V116 that are not included in any currently-licensed pneumococcal vaccine account for over 30 percent of this disease burden alone.”
Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae, or pneumococcus. Invasive forms of pneumococcal disease (IPD) can cause serious and potentially life-threatening infections such as bacteremia (infection in the bloodstream) and meningitis (infection of the coverings of the brain and spinal cord). Pneumonia (infection in the lungs), with or without bacteremia, also can occur. While healthy adults can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include adults 65 years of age and older and those with certain chronic or immunocompromising health conditions.