V116 Elicits Noninferiority Immune Response Compared with PPSV23 for Pneumococcal Disease

V116 (Merck), an investigational, adult-specific 21-valent pneumococcal conjugate vaccine, has demonstrated an immune response that was noninferior to the pneumococcal vaccine polyvalent (23-valent; PPSV23) for 12 serotypes common to both vaccines, according to a press release from the company. The company presented positive results from the STRIDE-10 phase 3 trial at the 34th European Society of Clinical Microbiology and Infectious Diseases in Barcelona, Spain, from April 27 to April 30, 2024.¹

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The trial, which was designed to evaluate the immunogenicity, tolerability, and safety of V116 compared with PPSV23 in adults aged 50 and older without a previous pneumococcal vaccination, also showed that the immune responses elicited by V116 were superior to 9 serotypes included in the vaccine but were not superior to those elicited by PPSV23. The vaccine also had a comparable safety profile to PPSV23, according to the press release.¹

This data builds upon previous results shared at the 13th Meeting of the International Society of Pneumonia and Pneumococcal Disease in Cape Town, South Africa, in March 2024. In these findings, V116 demonstrated immunogenicity for all 21 serotypes that were covered by the vaccine in a variety of adult populations across multiple studies. Populations included those who were pneumococcal vaccine-naïve, those who were vaccine-experienced, and those at an increased risk of disease, including patients with HIV.²

The results also showed that the vaccine candidate elicited higher immune responses than comparators for serotypes that were unique to V116, including for individuals who were vaccine experienced with the pneumococcal 15-valent conjugate vaccine (PCV15) and PPSV23, according to an article in Pharmacy Times.

Additionally, at the conference, real-world study data for approximately 2065 individuals aged 50 years and older who were hospitalized with community-acquired pneumonia showed that 84% of the serotypes were covered by V116. Further, 25% of the detected serotypes were covered only by V116 and not PCV15 or PCV20, according to the preliminary results.²

In the STRIDE-3 trial, V116 showed a noninferior immune response to PCV20, showing that the immune responses elicited by V116 were superior for 10 of 11 serotypes that were not included in PCV20. V116 also elicited noninferior immune responses for individuals aged 50 to 64, according to the results.³

In December 2023, following these data, the FDA granted priority review to the biologic license application for V116 to help prevent invasive pneumococcal disease and pneumococcal pneumonia in adults. According to Pharmacy Times, if the vaccine were to be approved, it would offer significant improvements in safety and effectiveness for the prevention of disease.⁴

Furthermore, in April 2022, the FDA granted breakthrough designation to V116 for the same patient populations.⁵

References

1. Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults. News release. Merck. April 29, 2024. Accessed May 3, 2024. https://www.merck.com/news/merck-announces-positive-data-for-v116-an-investigational-21-valent-pneumococcal-conjugate-vaccine-specifically-designed-for-adults/

2. Gallagher A. V116 Demonstrates Positive Immunogenicity for 21 Pneumococcal Serotypes. Pharmacy Times. March 22, 2024. Accessed May 3, 2024. https://www.pharmacytimes.com/view/v116-demonstrates-positive-immunogenicity-for-21-pneumococcal-serotypes

3. Gallagher A. Investigational Vaccine Has Non-Inferior Immune Response Compared to PCV20 for Pneumococcal Disease. Pharmacy Times. December 13, 2023. Accessed May 3, 2024. https://www.pharmacytimes.com/view/investigational-vaccine-has-non-inferior-immune-response-compared-to-pcv20-for-pneumococcal-disease

4. Gallagher A. FDA Grants Priority Review to New Biologics License Application for V116 Against Pneumococcal Disease. Pharmacy Times. December 19, 2023. Accessed May 3, 2024. https://www.pharmacytimes.com/view/fda-grants-priority-review-to-new-biologics-license-application-for-v116-against-pneumococcal-disease

5. Pharmacy Times. FDA Grants Breakthrough Designation to Merck's Investigational Pneumococcal Conjugate Vaccine Candidate. April 14, 2022. Accessed May 3, 2024. https://www.pharmacytimes.com/view/fda-grants-breakthrough-designation-to-merck-s-investigational-pneumococcal-conjugate-vaccine-candidate