Merck Reports Positive Phase 3 Results for V114, a 15-Valent Pneumococcal Conjugate Vaccine, and Plans Regulatory Submission by Year-End

Merck & Co., Inc. (MSD) today announced that its investigational 15-valent pneumococcal conjugate vaccine, V114, achieved positive results in two Phase 3 clinical trials. In the two Phase 3 trials, named PNEU-PATH (V114-016) and PNEU-DAY (V114-017), V114 met its primary immunogenicity endpoints, eliciting robust immune responses against all 15 serotypes included in the vaccine, including the two unique serotypes, 22F and 33F, covered by V114. The company plans to submit a regulatory application to the U.S. 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 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 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 the PNEU-PATH (V114-016) study, healthy adults aged 50 years and older received vaccination with either V114 or PCV13, followed by vaccination with Pneumovax23 one year later. For the 15 serotypes contained in V114, the immune responses following Pneumovax23 vaccination (at month 13) were comparable between the two vaccination groups. The results also showed that 30 days after vaccination with V114 or PCV13, the immune responses to the 13 serotypes shared by both vaccines were comparable between the two groups, while volunteers in the V114 group exhibited higher immune responses to serotypes 22F and 33F.

In the PNEU-DAY (V114-017) clinical trial, adults aged 18–49 years with underlying medical conditions that increase the risk of pneumococcal disease received vaccination with either V114 or PCV13. At 30 days post-vaccination, V114 elicited immune responses comparable to those of PCV13 against the 13 serotypes shared by both vaccines, and higher immune responses against serotypes 22F and 33F in the V114 group.

Merck & Co., Inc. stated that the Phase 3 clinical development program for V114 comprises 16 clinical trials designed to evaluate the safety, tolerability, and immunogenicity of V114 in diverse populations. The company remains on track to submit regulatory applications by the end of this year.

References:

[1] Merck Announces Positive Topline Results from Two Additional Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine. Retrieved October 20, 2020, from https://www.businesswire.com/news/home/20201020005258/en

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