Merck, known as MSD outside of the US and Canada, announced results from a Phase 2 trial (NCT02982972 ) evaluating the safety, tolerability and immunogenicity of V114.
It is the company’s investigational 15-valent pneumococcal conjugate vaccine, as compared to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) in healthy infants 6-12 weeks of age. In the study, designated V114-008, V114 met its primary endpoint by demonstrating noninferiority for the 13 serotypes contained in both vaccines.
V114 also induced an immune response in infants for two additional disease-causing serotypes, 22F and 33F, which are not contained in PCV13. In January 2019, V114 received a 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.
The FDA’s decision was informed in part by immunogenicity data from this Phase 2 study, V114-008, and the Phase 1/2 V114-005 study in healthy adults and infants. Results of the V114-008 study were presented during an oral session at the 37th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID) in Ljubljana, Slovenia, and reinforce continued progression of Phase 3 clinical studies with V114.
“Children under the age of two are at increased risk for pneumococcal infection, which in some cases may lead to serious illnesses like pneumococcal pneumonia,” said Dr. David Greenberg, study investigator and physician in the Pediatric Infectious Disease Unit of Soroka University Medical Center in Beer-Sheva, Israel. “These Phase 2 data evaluating V114 in infants are encouraging and mark important progress to helping expand protection against pneumococcal disease for this vulnerable patient population.”
V114-008, a double-blind, randomized, Phase 2 trial, compared the safety, tolerability, and immunogenicity of two different clinical lots of V114 (n=350 for lot 1; n=347 for lot 2) to PCV13 (n=347) in approximately 1,050 healthy infants at two, four, six and 12-15 months of age.
In the study, the percentage of subjects who achieved the WHO-accepted threshold of immune response (IgG≥0.35 mcg/mL) with either lot of 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 (96.0% for lot 1; 94.1% for lot 2) compared with PCV13 (71.8%).
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% (98.9% for lot 1; 98.5% for lot 2) and above 87% (87.7% for lot 1; 90.1% for lot 2), respectively. Results were consistent between the two lots of V114 studied.
Safety profiles were evaluated after each dose and throughout the study. In the study, the adverse event profile for V114, including the number of serious adverse events (AEs), was found to be comparable to PCV13. The percentage of subjects who reported clinical AEs and serious AEs was similar in all treatment arms. The most commonly reported adverse events were injection site reactions, the majority of which were mild to moderate in severity and of short duration.
“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.”
Merck has a broad clinical development program for V114 currently comprised of 11 Phase 3 clinical trials. These studies are investigating V114 in adults (NCT03480763, NCT03615482), in the pediatric population (NCT03692871, NCT03620162, NCT03885934, NCT03893448), and in immunocompromised persons and those at increased risk for invasive pneumococcal disease (NCT03547167, NCT03921424, NCT03731182, NCT03480802, NCT03565900).
Source: Company Press Release.