Merck's Investigational 15-Valent Pneumococcal Conjugate Vaccine V114 Meets Primary Endpoints in Phase 3 Trials, Aiming for Regulatory Submission by Year-End

MSD Announces That Its Investigational 15-Valent Pneumococcal Conjugate Vaccine, V114, Met Primary Immunogenicity Endpoints in Two Phase 3 Clinical TrialsMerck Sharp & Dohme (MSD) announced today that its investigational 15-valent pneumococcal conjugate vaccine, V114, met the primary immunogenicity endpoints in two Phase 3 clinical trials. Results from the pivotal clinical trial conducted in healthy adults aged 50 years and older (PNEU-AGE) demonstrated that V114 met the non-inferiority criteria for the 13 serotypes common to both V114 and the currently licensed 13-valent pneumococcal conjugate vaccine (PCV13). For the two additional serotypes targeted by V114 but not by PCV13 (serotypes 22F and 33F), V114 met the superiority criteria. The company plans to submit a regulatory application to the U.S. Food and Drug Administration (FDA) by the end of this year.

Pneumococcal disease is an infection caused by Streptococcus pneumoniae. Highly invasive strains or serotypes may place more individuals at risk for both non-invasive pneumococcal diseases (such as pneumococcal pneumonia, sinusitis, and otitis media) and invasive pneumococcal diseases (such as pneumococcal bacteremia, bacteremic pneumonia, and pneumococcal meningitis). Although healthy adults and children can contract pneumococcal disease, susceptible populations include children under 2 years of age, adults aged 65 years and older, and individuals with immunosuppression or certain chronic conditions.

V114 is a 15-valent pneumococcal conjugate vaccine developed by Merck Sharp & Dohme (MSD) for the prevention of pneumococcal disease in adults and children. It consists of pneumococcal polysaccharides from 15 serotypes, including serotypes 22F and 33F, conjugated to the CRM197 carrier protein. These serotypes are commonly associated with invasive pneumococcal disease worldwide and are not included in currently approved pneumococcal conjugate vaccines for adults.

In addition to meeting the primary endpoint, the PNEU-AGE trial also met the key secondary immunogenicity endpoints, demonstrating the superiority of V114 over PCV13 against serotype 3 (the leading cause of invasive pneumococcal disease worldwide).

In another Phase 3 clinical study, PNEU-TRUE, the investigational V114 vaccine from three different batches elicited comparable immune responses across all 15 serotypes in healthy adults aged 50 years and older. In both studies, V114 demonstrated a favorable tolerability and safety profile.

“Diseases caused by serotypes not covered by existing pneumococcal conjugate vaccines are increasing globally. Furthermore, we continue to see pneumococcal disease caused by serotypes included in current pneumococcal vaccines,” said Dr. Roy Baynes, Chief Medical Officer and Head of Global Clinical Development at MSD Laboratories. “We need to continue scientific innovation in the prevention of pneumococcal disease to target the serotypes that pose the greatest risk to specific populations. These Phase 3 clinical trial data demonstrate that V114 elicited robust immune responses against all 15 serotypes included in the vaccine, further highlighting the potential of this investigational vaccine to help protect adults against pneumococcal disease.”

References:

[1] Merck Announces Positive Topline Results from Two Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, Including Pivotal Trial. Retrieved September 9, 2020, from https://www.businesswire.com/news/home/20200909005303/en

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