Merck's 15-Valent Pneumococcal Conjugate Vaccine V114 Meets Primary Immunogenicity Endpoints in Two Phase 3 Trials

Reposted from: Jike Pharmaceutical News

Today, Merck & Co., Inc. (MSD) announced preliminary results from two Phase 3 clinical studies of its investigational 15-valent pneumococcal conjugate vaccine, V114, which evaluated the safety, tolerability, and immunogenicity of V114. The PNEU-WAY (V114-018) study, conducted in adults aged 18 years and older living with HIV, demonstrated that V114 elicited immune responses against all 15 serotypes included in the vaccine, including serotypes 22F and 33F. The PNEU-FLU (V114-021) study, conducted in healthy adults aged 50 years and older, showed that V114 can be co-administered with the quadrivalent influenza vaccine. These data were presented on the online platform of the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD).

V114 is a 15-valent pneumococcal conjugate vaccine currently in Phase 3 clinical development. In January 2019, it received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for use in pediatric patients aged 6 weeks through 18 years to prevent invasive pneumococcal disease caused by 15 serotypes, including serotypes 22F and 33F (which are not included in currently approved pneumococcal conjugate vaccines for adults). The Phase 3 clinical development program for V114 comprises 16 studies. Merck & Co., Inc. plans to submit marketing applications for this vaccine to the U.S. FDA and other regulatory authorities worldwide after obtaining data from additional Phase 3 studies.

PNEU-WAY is a Phase 3, multicenter, randomized, double-blind, controlled study designed to evaluate the safety, tolerability, and immunogenicity of V114. A total of 302 participants were randomized in a 1:1 ratio to receive either V114 (N=152) or the currently available 13-valent pneumococcal conjugate vaccine (PCV13) (N=150). Thirty days after vaccination, V114 met its primary immunogenicity endpoints. In an exploratory comparative analysis, the immunogenicity metrics for the 13 serotypes common to both V114 and PCV13 were largely comparable. Furthermore, for the two serotypes unique to V114 (22F and 33F), the immune responses in the V114 group were higher than those in the PCV13 group. The safety profile of V114 was comparable to that of PCV13.

PNEU-FLU is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of V114 administered concurrently or non-concurrently with influenza vaccine in healthy adults aged 50 years and older (N=1200). The study met its two primary immunogenicity endpoints. Based on serotype-specific immunogenicity measures at 30 days post-vaccination with V114, concurrent administration of V114 with QIV (a quadrivalent influenza vaccine) met the non-inferiority criteria compared to non-concurrent administration of V114 with QIV.

Pneumococcal disease is an infection caused by Streptococcus pneumoniae. Highly invasive strains or serotypes can cause non-invasive pneumococcal diseases, such as pneumonia, sinusitis, and otitis media, as well as invasive pneumococcal diseases, such as bacteremia (bloodstream infection), bacterial pneumonia, and meningitis. Susceptible populations include children under 2 years of age, adults aged 65 years and older, and individuals with compromised immune systems or chronic medical conditions.

Dr. Luwy Musey, Executive Director of Biologics Clinical Research for Vaccines at MSD Research Laboratories, stated, “The results from the first two Phase 3 studies of V114 are encouraging, and we look forward to sharing additional clinical study data in the future, including pivotal studies evaluating the immunogenicity of V114 and its potential to protect against the serotypes most likely to cause invasive disease.”

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