PNEU-WAY (V114-018) and PNEU-FLU (V114-021) Part of Broad Phase 3 Clinical Program
Filing Planning Underway with Regulatory Authorities
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results from two initial Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. Results from the PNEU-WAY (V114-018) study in adults 18 years of age or older living with Human Immunodeficiency Virus (HIV) showed that V114 elicited an immune response to all 15 serotypes included in the vaccine, including serotypes 22F and 33F. Results from the PNEU-FLU (V114-021) study in healthy adults 50 years of age or older showed that V114 can be given concomitantly with the quadrivalent influenza 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.
"Certain populations are at greater risk for pneumococcal disease, reinforcing the importance of investigating new interventions focused on their specific needs," said Dr. Luwy Musey, executive director in biologics, vaccine clinical research, Merck Research Laboratories. "Results from these first two Phase 3 studies of V114 are encouraging and we look forward to sharing additional data in the future from our ongoing clinical development program, including our pivotal studies assessing the immunogenicity of V114 and its potential to protect against the serotypes most likely to cause invasive disease."
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 both healthy older adult and healthy pediatric populations, as well as people who are immunocompromised or have certain chronic conditions. An overview of the late-stage development program is available here. The company plans to continue to work with the U.S. Food and Drug Administration (FDA) and other regulatory authorities around the world on filing plans for licensure of this vaccine as additional data from the Phase 3 program become available.
PNEU-WAY was a Phase 3, 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 as measured by serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) and Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for all 15 serotypes contained in the vaccine at 30 days post-vaccination. In an exploratory comparative analysis, the OPA GMTs and IgG GMCs for the 13 shared serotypes between V114 and PCV13 were generally comparable between the two groups. 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 was a Phase 3, 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. V114 administered concomitantly with QIV was noninferior compared to V114 administered non-concomitantly with QIV, based on the serotype-specific OPA GMTs at 30 days post-vaccination with V114. Additionally, QIV administered concomitantly with V114 was noninferior to QIV administered non-concomitantly with V114, based on the influenza strain-specific hemagglutination inhibition (HAI) GMTs at 30 days post-vaccination with QIV. The safety profiles were generally comparable between the two vaccination groups based on the cumulative safety data.
V114 is Merck’s investigational 15-valent pneumococcal conjugate vaccine in Phase 3 development 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
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 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.
Indication for PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent)
PNEUMOVAX 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F and 33F).
PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.
PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.
Select Safety Information for PNEUMOVAX 23
Do not administer PNEUMOVAX 23 to individuals with a history of a hypersensitivity reaction to any component of the vaccine.
Defer vaccination with PNEUMOVAX 23 in persons with moderate or severe acute illness.
Use caution and appropriate care in administering PNEUMOVAX 23 to individuals with severely compromised cardiovascular and/or pulmonary function in whom a systemic reaction would pose a significant risk.
Available human data from clinical trials of PNEUMOVAX 23 in pregnancy have not established the presence or absence of a vaccine-associated risk.
Since elderly individuals may not tolerate medical interventions as well as younger individuals, a higher frequency and/or a greater severity of reactions in some older individuals cannot be ruled out.
Persons who are immunocompromised, including persons receiving immunosuppressive therapy, may have a diminished immune response to PNEUMOVAX 23.
PNEUMOVAX 23 may not be effective in preventing pneumococcal meningitis in patients who have chronic cerebrospinal fluid (CSF) leakage resulting from congenital lesions, skull fractures or neurosurgical procedures.
The most common adverse reactions, reported in >10% of subjects vaccinated with PNEUMOVAX 23 in clinical trials, were: injection-site pain/soreness/tenderness, injection-site swelling/induration, headache, injection-site erythema, asthenia and fatigue, and myalgia.
For subjects aged 65 years or older in a clinical study, systemic adverse reactions which were determined by the investigator to be vaccine-related were higher following revaccination than following initial vaccination.
Vaccination with PNEUMOVAX 23 may not offer 100% protection from pneumococcal infection.
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, Merck has multiple programs that span discovery through late-stage development. To learn more about Merck’s infectious diseases pipeline, visit www.merck.com.
For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
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