V116 Pneumococcal Conjugate Vaccine Description
V116 is Merck's investigational 21-valent pneumococcal conjugate vaccine.
V116 received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) 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.
V116 Indication
“V116 is specifically designed to address strains of disease-causing pneumococcal bacteria that are most prevalent in adults, reflecting our population-specific approach to developing pneumococcal conjugate vaccines. V116 targets serotypes that account for 85% of all invasive pneumococcal disease in individuals aged 65 and over in the United States as of 2019, and it includes 8 serotypes not covered by currently licensed vaccines,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.
V116 News
July 28, 2022 - Merck presented positive results from the Phase 1/2 study for V116, Merck’s investigational Pneumococcal 21-Valent Conjugate Vaccine designed to target serotypes that account for 85% of all invasive pneumococcal diseases in U.S. adults 65 years and older as of 2019, and enrolled the first patient into the Phase 3 STRIDE-3 trial evaluating V116 in vaccine-naïve adults. V116 contains eight serotypes not included in any currently licensed pneumococcal vaccine.
June 21, 2022 - Merck (NYSE: MRK) 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).
April 14, 2022 - V116, Merck’s investigational 21-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) 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.
V116 Clinical Trials
Merck's 21-valent pneumococcal conjugate vaccine (PCV) has been in clinical trials since 2019.
Phase 1/2 trial has been completed, and the full study results from V116-001 will be published in a scientific journal in the future.
There are 3 Phase 3 trials that are announced but not yet recruiting.
