Positive Results Announced From Phase 3 Adult Studies Evaluating 15-valent Pneumococcal Conjugate Vaccine

September 14th 2020

Two phase 3 studies showed an investigational 15-valent pneumococcal conjugate vaccine (V114, Merck) was well-tolerated among patients and met the primary immunogenicity objectives.

Two phase 3 studies showed an investigational 15-valent pneumococcal conjugate vaccine (V114, Merck) was well-tolerated among patients and met the primary immunogenicity objectives.

The phase 3 Pneu-age study assessed the vaccine’s efficacy in healthy adults aged 50 years or older. The results showed that the vaccine was not inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13), according to the researchers.

In this study, the new 15-valent vaccine was found to be as successful in targeting the 13 serotypes that are currently targeted in the 13-valent version, with the V114 vaccine being superior in targeting serotypes 22F and 33F. This study also demonstrated the 15-valent vaccine was superior in targeting serotype 3, which is known to be a leading cause of invasive pneumococcal disease globally.

In the Pneu-true study, the researchers found V114 successfully demonstrated equivalent immune response across all 15 serotypes in healthy adults aged 50 years or older. In both studies, the researchers found that V114 was not only well-tolerated among patients, but the safety profile of the vaccine was comparable with the current PCV13 and consistent with the results of previous studies that assessed V114.

Merck plans to present these results and any additional phase 3 data from its clinical program to the public, allowing the data to form the basis of global regulatory licensure applications before the end of 2020.

“Diseases caused by serotypes not covered by the currently available pneumococcal conjugate vaccine are increasing worldwide and can vary by country or region. Additionally, we continue to see pneumococcal disease caused by serotypes included in the existing pneumococcal vaccines,” said Roy Baynes, MD, PhD, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories, in a press release.

The pneumococcal serotypes that are not included in the current 13-valent pneumococcal conjugate vaccine, such as 22F and 33F, have been found to be associated with invasive pneumococcal disease throughout the country. These 2 serotypes, 22F and 33F, specifically cause 13% of the invasive pneumococcal disease observed in adults aged 65 years and older in the United States.

Additionally, serotype 3, which is targeted in V114, remains a leading cause of invasive pneumococcal disease in adults and children, despite the current 13-valent version in use also targeting this serotype. In total, 15% of invasive pneumococcal disease among adults aged 65 years and older is still caused by serotype 3 in the United States.

“These phase 3 data demonstrated that V114 generated a robust immune response to all 15 serotypes included in the vaccine and reinforce the potential for this investigational vaccine to help protect adults against pneumococcal disease,” Baynes said.

Baynes noted that additional research into pneumococcal disease prevention is necessary in order to target those serotypes that remain a risk factor for certain populations.

REFERENCE

Merck Announces Positive Topline Results from Two Phase 3 Adult Studies Evaluating V114, Merck’s Investigational 15-valent Pneumococcal Conjugate Vaccine, Including Pivotal Trial. Kenilworth, NJ: Merck; September 9, 2020. merck.com/news/merck-announces-positive-topline-results-from-two-phase-3-adult-studies-evaluating-v114-mercks-investigational-15-valent-pneumococcal-conjugate-vaccine-including-pivotal-trial/. Accessed September 11, 2020.

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