KENILWORTH, N.J.—Pharmaceutical giant Merck & Co. Inc., known as MSD outside of the U.S. and Canada, has announced exciting results from the Phase 2 trial of their potential new pneumococcal conjugate vaccine, with what its leaders say is enough significant positive data to support continued Phase 3 investigation. In January 2019, Merck was granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age.
Streptococcus pneumoniae is a bacterium characterized by scores of serotypes, many of which cause disease in humans. While some of these diseases are not serious, 10 of the most common types cause 62 percent of invasive disease worldwide, with the highest burden of disease falling on the very young and the very old. Though an initial pneumococcal conjugate vaccine (PCV) was licensed in the U.S. in 2000, investigation has continued to find more effective, broad-spectrum vaccines.
“Pneumococcal disease remains a significant cause of morbidity with the greatest burden of disease in children less than 5 and adults older than 65,” states Merck senior principal scientist Dr. Heather Platt. “Understanding this burden of disease led to our comprehensive approach to prevent pneumococcal disease and, thus, the development of V114, which is focused not only on providing additional disease coverage based on the epidemiology of pneumococcal disease, but also eliciting a strong immune response across all serotypes contained in our vaccines.”
The first IPD vaccine contained seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) of Streptococcus pneumoniae and became known as PCV7. Ten years later in February 2010, a new 13-valent product was licensed—PCV13—which added six new serotypes (1, 3, 5, 6A, 7F and 19A). Together, these 13 serotypes account for the majority of IPD in the United States. Merck has now expanded the scope, with V114 targeting 15 serotypes for the first time. Once awarded Breakthrough Therapy Designation in January, Merck ramped up their Phase 2 trials, leading to these promising findings.
The Breakthrough Therapy Designation is one way the FDA tries to accelerate the pipeline for effective treatments for more serious or life-threatening conditions. The proposed therapy must show realistic promise as a significant improvement over existing options, and prompts substantial investment of expertise and other resources from the FDA to achieve a successful therapy.
“V114 consists of pneumococcal polysaccharides from 15 serotypes conjugated to a CRM197 carrier protein, and includes serotypes 22F and 33F that are commonly associated with invasive pneumococcal disease worldwide and not covered by currently marketed vaccines for this disease,” asserts Platt.
The data show that V114 induced an immune response in infants for two disease-causing serotypes (22F and 33F) not contained in the currently available 13-valent pneumococcal conjugate vaccine, while demonstrating non-inferiority for the serotypes contained in both vaccines. The studies have shown that V114 induced the WHO-accepted level of immune response with either of the added serotypes. V114 was noninferior to the percentage seen with PCV13 for the 13 serotypes shared between the two vaccines. For serotype 3, the percentage of subjects who achieved this threshold of immune response was higher for V114 compared with PCV13. For the two serotypes not included in PCV13, serotype 22F and serotype 33F, the percentage of subjects who achieved the defined threshold of immune response with V114 was above 98 percent and above 87 percent, respectively.
“These new data for our investigational pneumococcal disease vaccine V114 build on Merck’s century-long heritage in vaccines and our commitment to improving global health through protection from infectious diseases,” said Dr. Nicholas Kartsonis, senior vice president and head of vaccine and infectious diseases clinical research at Merck Research Laboratories. “We are deeply committed to advancing compounds such as V114 that have the potential to make a meaningful impact on the burden of pneumococcal disease.”
