Topline data results from the company’s phase 3 trial, STRIDE-3, were announced and will be presented at the World Vaccine Congress West Coast.
This morning, Merck announced its 21-valent pneumococcal conjugate vaccine candidate, V116, was superior in immune response for 10 of 11 unique serotypes compared to PCV20 in adults 50 years of age and older.
According to Merck, topline results from the study included:
“Invasive forms of pneumococcal disease can cause serious and sometimes life-threatening complications, such as pneumococcal pneumonia, pneumococcal meningitis and bacteremia, especially for older or immunocompromised adults,” said Sady Alpizar, MD, Clinical Research Trials of Florida, and a principal investigator of the study. “These encouraging results demonstrate that V116 has the potential to help prevent invasive pneumococcal disease among vulnerable populations.”
V116 demonstrated superior immune responses for 10 out of 11 unique serotypes compared to PCV20 in adults aged 50 years and older.
In adults aged 18 to 49 years (cohort 2), V116 showed non-inferior immune responses compared to adults aged 50 to 64 years.
V116 is specifically designed to address Streptococcus pneumoniae serotypes that are predominantly responsible for adult pneumococcal disease, including eight unique serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31, and 35B).
In past reporting by Contagion, V116 demonstrated statistically significant immune responses in both vaccine-naive adults and those previously vaccinated in 2 phase 3 trials. V116 is specifically designed to address Streptococcus pneumoniae serotypes predominantly responsible for adult pneumococcal disease, including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B, which account for approximately 30% of adult disease, according to CDC data from 2018-2021.
The serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in individuals 65 years of age and older, based on CDC data. Pneumococcal disease is an infection caused by bacteria called Streptococcus pneumoniae. There are more than 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Certain serotypes threaten to put more people at risk for invasive pneumococcal illnesses, such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the coverings of the brain and spinal cord), as well as non-invasive pneumonia (when pneumococcal disease is confined to the lungs).
There are currently 3 licensed pneumococcal conjugate vaccines: PCV13, which covers serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F); PCV15, which covers serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F); and PCV20, which covers serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F); as well as 1 pneumococcal polysaccharide vaccine, PPSV23 (serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F).
The V116 Phase 3 Trials
The V116 phase 3 clinical development program is composed of 8 trials (n=8830) investigating the safety, tolerability, and immunogenicity of V116 in various adult populations. These include adults with and without chronic medical conditions associated with an increased risk of pneumococcal disease, as well as individuals who previously received a pneumococcal vaccine.
Next Steps
The company said in the statement it was sharing data from STRIDE-3 with global regulatory authorities. “We are excited by the potential of V116 to impact public health through primary prevention through the use of a population-specific strategy that targets the serotypes responsible for the majority of invasive pneumococcal disease in adults,” said Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories.
Reference
Merck’s V116, an Investigational, 21-valent Pneumococcal Conjugate Vaccine Specifically Designed to Protect Adults, Demonstrated Superior Immunogenicity for 10 of 11 Unique Serotypes Compared to PCV20 in Adults 50 Years of Age and Older. Merck press release. November 28, 2023. https://www.merck.com/news/mercks-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-to-protect-adults-demonstrated-superior-immunogenicity-for-10-of-11-unique-serotypes-compared/
