In the PNEU-PATH (V114-016) study, healthy adults 50 years of age or older received V114 or PCV13 followed by PNEUMOVAX 23 one year later. Immune responses following vaccination with PNEUMOVAX 23 (month 13) were comparable in both vaccination groups for the 15 serotypes in V114. Results also showed that at 30 days post vaccination with either V114 or PCV13 (day 30), immune responses were comparable for both groups across the 13 serotypes shared by the conjugate vaccines and higher in the V114 group for serotypes 22F and 33F, the two serotypes not included in PCV13. In PNEU-DAY (V114-017), a Phase 3 study in immunocompetent adults 18 to 49 years of age with underlying medical conditions associated with increased risk for pneumococcal disease, V114 generated immune responses generally comparable to PCV13 for the 13 shared serotypes and higher immune responses for serotypes 22F and 33F at 30 days post-vaccination. Results from both studies are based on opsonophagocytic activity (OPA) responses a measure of vaccine-induced functional antibodies. V114 was generally well tolerated in both studies, with a safety profile consistent with that observed for V114 in previously reported studies.
'Pneumococcal disease in adults is on the rise globally, in part driven by disease-causing serotypes not targeted by the currently available pneumococcal conjugate vaccine,' said Dr.
Findings from the V114 Phase 3 clinical program in adults, including PNEU-PATH and PNEU-DAY, will be presented at a future scientific congress. Plans for global regulatory licensure applications, beginning with the
There are more than 90 different types of pneumococcal bacteria which can affect adults differently than children. Pneumococcal serotypes not in the currently licensed conjugate vaccine, such as 22F and 33F, are among the most common serotypes causing invasive pneumococcal disease in parts of the world, including the
The V114 Phase 3 clinical development program is comprised of 16 trials investigating the safety, tolerability and immunogenicity of V114 in a variety of populations who are at increased risk for pneumococcal disease, including healthy older adults and children, as well as people who are immunocompromised or have certain chronic medical conditions. An overview of the late-stage development program is available here.
About PNEU-PATH
PNEU-PATH is a Phase 3, multi-center, randomized, double-blind, active comparator-controlled study evaluating the safety, tolerability and immunogenicity of V114 followed by administration of PNEUMOVAX 23 one year later in healthy adults 50 years of age or older (n=652). The primary endpoints included serotype specific OPA geometric mean titers (GMTs) at 30 days post-vaccination with PNEUMOVAX 23. The serotype specific OPA GMTs at 30 days post-vaccination with PNEUMOVAX 23 were comparable in the V114 and PCV13 groups for all 15 serotypes in V114.
Secondary endpoints included serotype specific OPA GMTs at 30 days post-vaccination with either V114 or PCV13. The OPA GMTs were comparable for the 13 shared serotypes between V114 and PCV13 at 30 days post-vaccination with either V114 or PCV13. The OPA GMTs were higher in the V114 group compared with the PCV13 group for the two serotypes unique to V114 (22F and 33F) at 30 days post-vaccination with either V114 or PCV13. Results of the safety analyses demonstrated that V114 was generally well tolerated and can be followed by PNEUMOVAX 23.
About PNEU-DAY
PNEU-DAY is a Phase 3, multi-center, randomized, double-blind, active comparator-controlled study evaluating the safety, tolerability and immunogenicity of V114 followed by administration of PNEUMOVAX 23 six months later in adults between 18 and 49 years of age who are at increased risk for pneumococcal disease due to an underlying medical condition, behavioral habits, or living in an environment with increased risk of disease transmission (n=1,514). Participants were considered at increased risk for pneumococcal disease due to the presence of one or more risk factors, including chronic lung disease, smoking, diabetes mellitus, chronic liver disease, chronic heart disease and alcohol consumption.
The primary endpoints included serotype specific OPA GMTs at 30 days post-vaccination with either V114 or PCV13. The OPA GMTs were generally comparable for the 13 shared serotypes between V114 and PCV13 at 30 days post-vaccination. The OPA GMTs were higher in the V114 group compared with the PCV13 group for the two serotypes unique to V114 (22F and 33F) at 30 days post-vaccination.
Results of the safety analyses demonstrated that V114 was generally well tolerated with a safety profile generally comparable to PCV13 and consistent with that observed in previously reported studies.
About V114
V114 is
About Pneumococcal Disease
The global prevalence of pneumococcal disease, an infection caused by bacteria called Streptococcus pneumoniae, is evolving. Highly aggressive strains, or serotypes, threaten to put more people at risk for non-invasive pneumococcal illnesses such as pneumococcal pneumonia (when it is confined to the lungs), sinusitis, and otitis media (middle ear infection), and invasive pneumococcal illnesses such as pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord). 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.
About
For more than 125 years,
Forward-Looking Statement of
This news release of
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the
Contact:
Tel: (267) 305-3558
(C) 2020 Electronic News Publishing, source