Merck Presents Positive Results From Phase 1/2 Study Of Pneumococcal Conjugate Vaccine

(RTTNews) - Merck & Co., Inc. (MRK) said it has presented positive results from the phase 1/2 study, dubbed as V116-001, evaluating the safety, tolerability and immunogenicity of V116, the company's investigational 21-valent pneumococcal conjugate vaccine, in pneumococcal vaccine-naïve adults 18-49 years of age and 50 years of age and older.

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 geometric mean titers, a measure of functional antibody activity.

Broad phase 3 clinical program for V116 in vaccine-naïve and vaccine-experienced adults is planned to start in July 2022.

Earlier this year, V116 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the prevention of invasive pneumococcal disease 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.