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Positive data were presented at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Disease in Cape Town, South Africa.
V116 (Merck), an investigational adult-specific 21-valent pneumococcal conjugate vaccine, demonstrated immunogenicity for all 21 serotypes covered by the vaccine in a variety of adult populations in multiple studies. The populations included those who were pneumococcal vaccine-naïve, those who were pneumococcal vaccine-experienced, and those with an increased risk of pneumococcal disease including individuals with HIV, according to a press release from the company.
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Positive data were presented at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Disease in Cape Town, South Africa.
“Invasive pneumococcal disease and pneumococcal pneumonia can cause serious illness, especially in older adults and those with immunocompromising conditions,” Walter Orenstein, MD, professor emeritus of medicine, epidemiology, global health, and pediatrics at Emory University, said in the press release. “These positive data demonstrate the potential for V116 to address an unmet need in adult pneumococcal disease prevention.”
The results also showed that V116 elicited higher immune responses than the comparators in the study for serotypes that are unique to V116, according to a press release. Investigators found that for individuals who are vaccine-naïve aged 50 years and older, the vaccine showed immunogenicity for all 21 serotypes across patients aged 50 to 64 years, 65 to 74 years, and 75 to 84 years at 30 days.
Additionally, for those who are vaccine-experienced, the study vaccine elicited a comparable response to serotypes with the pneumococcal 15-valent conjugate vaccine (PCV15) or the pneumococcal vaccine polyvalent 23-valent (PPSV23), according to the press release. Further, the investigators found that V116 had higher immune responses for the serotypes covered by just the study drug at day 30, regardless of previous vaccine received or time since prior pneumococcal vaccination.
Furthermore, individuals aged 18 years and older with HIV demonstrated comparable immune responses with V116 to PCV15 and PPSV23 for all 13 shared serotypes and higher immune responses for all 8 serotypes covered by V116 only at 30 days, according to the press release. Across all studies demonstrated a safety profile comparable to pneumococcal 20-valent conjugate vaccine, PCV15, and PPSV23.
Merck also presented preliminary data from a real-world study in the United States that included 2065 adults aged 50 years and older hospitalized with community-acquired pneumonia between 2018 and 2022 with 242 pneumococcal serotypes detected. Investigators of the study found that approximately 84% of the serotypes were covered by V116, according to the press release, and approximately 25% of the detected serotypes were covered only by V116 and no PCV15 or PCV20. The study also showed that serotypes in V116 accounted for the majority of pneumococcal disease, which included invasive and non-invasive diseases, in adults aged 50 and older.
“The extensive data presented this week reaffirm our confidence in the potential clinical value V116 could provide to a range of adult populations,” Eliav Barr, MD, senior vice president and head of global clinical development and chief medical officer at Merck Research Laboratories, said in the press release. “We are encouraged by the results of these studies showing that V116 has generated immune responses to the serotypes responsible for the majority of adult invasive pneumococcal disease.”
Merck included several of the studies presented in the filing submission to the FDA, which granted a prescription drug user fee act of June 17, 2024. If approved it would be the first pneumococcal conjugate vaccine specifically designed for adults, according to the press release.
Reference
Merck Announces Positive Data on V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults, Demonstrated Immune Responses in Adults. News release. Merck. March 19, 2024. Accessed March 19, 2024. https://www.merck.com/news/merck-announces-positive-data-on-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-for-adults-demonstrated-immune-responses-in-adults/
