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A New Frontier in Pneumococcal Vaccination: Merck's V116 Shows Promising Results

In a significant stride towards advancing adult pneumococcal disease prevention, pharmaceutical giant Merck has unveiled encouraging results from its latest Phase 3 trial, STRIDE-3, focusing on V116, an investigational 21-valent pneumococcal conjugate vaccine. This development heralds a potential game-changer in the realm of infectious disease management, especially for adults above 50 years.

The Core of V116's Innovation

V116 is engineered to offer protection against 21 serotypes of the pneumococcus bacterium, which, as per the Centers for Disease Control and Prevention (CDC) data from 2018-2021, are responsible for approximately 83% of invasive pneumococcal diseases in individuals aged 65 and above. Remarkably, eight of these serotypes, not covered by existing vaccines, account for around 30% of invasive cases in the same age group.

Striking Results from STRIDE-3

The STRIDE-3 trial, a comprehensive study involving 2,663 adult participants, has yielded promising outcomes. In adults aged 50 and older, V116 demonstrated non-inferior immune responses to the current pneumococcal 20-valent conjugate vaccine (PCV20) for all 10 shared serotypes. Furthermore, for 10 out of 11 serotypes exclusive to V116, it showed superior immunogenicity compared to PCV20.

In the 18-49 age cohort, V116 elicited immune responses on par with those observed in adults aged 50-64, suggesting a broad spectrum of efficacy. The vaccine's safety profile was found to be comparable to PCV20, with no significant adverse effects, underscoring its potential for widespread use.

Implications for Public Health

The advent of V116 could revolutionize the approach towards preventing pneumococcal diseases, particularly among older and immunocompromised adults. Dr. Eliav Barr, Senior Vice President at Merck Research Laboratories, emphasizes,  

“These results provide strong evidence to support the immunogenicity of V116 compared to the standard of care in the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults. 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.”

Furthermore, Dr. Sady Alpizar of Clinical Research Trials of Florida, a principal investigator in the study, points out the crucial need for such advancements in preventing life-threatening complications like pneumococcal pneumonia and meningitis. Dr. Alpizar pointed out, 

“These encouraging results demonstrate that V116 has the potential to help prevent invasive pneumococcal disease among vulnerable populations.”

Next Steps and Regulatory Pathways

As V116 progresses through the clinical development phase, involving eight trials with over 8,000 participants, Merck continues to engage with global regulatory authorities. These discussions are crucial for the vaccine's approval and eventual deployment in adult immunization programs.

Merck's V116 represents a significant leap in adult pneumococcal disease prevention. The promising results from the STRIDE-3 trial not only affirm the vaccine's effectiveness and safety but also its potential to fill a critical gap in the current vaccination landscape. 

About V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine in Phase 3 development for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population. 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 the same CDC data.

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