Merck announced results from two Phase 3 studies, PNEU-WAY (V114-018) and PNEU-FLU (V114-021), evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. These data, in addition to results from V110-029, a study evaluating PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) in healthy adults 50 years of age or older, were published via the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) online digital library.
PNEU-WAY (V114-018) was a multicenter, randomized, double-blind, active comparator-controlled study to evaluate the safety, tolerability and immunogenicity of V114 followed by administration of PNEUMOVAX 23 eight weeks later in adults 18 years of age or older living with HIV. A total of 302 participants were randomized 1:1 to receive V114 (N=152) or the currently available 13-valent pneumococcal conjugate vaccine (PCV13) (N=150) followed by PNEUMOVAX 23. V114 met its primary immunogenicity objective for all 15 serotypes contained in the vaccine at 30 days post-vaccination. Additionally, immune responses were higher in the V114 group compared with the PCV13 group for the two serotypes unique to V114 (22F and 33F). The safety profile of V114 was generally comparable with PCV13.
PNEU-FLU (V114-021) was a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of V114 when administered concomitantly or non-concomitantly with the influenza vaccine in healthy adults 50 years of age or older (N=1,200). Participants randomized to the concomitant group received V114 and the quadrivalent influenza vaccine (QIV) on Day 1 and received placebo approximately 30 days later at Visit 2. Participants randomized to the non-concomitant group received placebo and QIV on Day 1 and received V114 approximately 30 days later at Visit 2. The study met both of its primary immunogenicity objectives. The safety profiles were generally comparable between the two vaccination groups based on the cumulative safety data.
The V114 Phase III clinical program includes 16 studies globally that are designed to evaluate safety, tolerability and immunogenicity across adult and pediatric populations, including special populations at increased risk for pneumococcal disease. On overview of the phase III program can be found here. Merck is working with the U.S. FDA and other global regulatory authorities on plans for filing for regulatory approval of V114 as additional data from the Phase 3 program become available.
V114 is a 15-valent pneumococcal conjugate vaccine developed for the prevention of pneumococcal disease in adults and children. V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein and includes serotypes 22F and 33F, which are commonly associated with invasive pneumococcal disease worldwide and are not contained in the pneumococcal conjugate vaccine currently licensed for use in adults.
About Pneumococcal Disease
Pneumococcal Disease is an infection caused by bacteria called Streptococcus pneumoniae. Highly aggressive strains, or serotypes, threaten to put more people at risk for non-invasive pneumococcal illnesses such as pneumonia (when it is confined to the lungs), sinusitis, and otitis media (middle ear infection); and invasive pneumococcal illnesses such as bacteremia (infection in the bloodstream), bacteremic pneumonia (pneumonia with bacteremia) and meningitis. While healthy adults and children can suffer from pneumococcal disease, patient populations particularly vulnerable to infection include children under the age of 2, older adults such as those 65 years of age and older, and people with immunosuppressive or certain chronic health conditions.