Phase I/II data indicate that new investigative pneumococcal conjugate vaccine shows efficacy in preventing disease in adults.
Globally, pneumococcal disease is responsible for a large burden of morbidity and mortality, especially in older adults. Therefore, a pneumococcal conjugate vaccine (PCV) specifically focused on serotypes associated with adult residual disease burden is urgently needed.
This led a group of researchers to evaluate a new vaccine1 that is specifically focused on prevention of pneumococcal disease in adults and also complements the protection afforded by childhood vaccination.
“We aimed to assess V116, an investigational 21-valent PCV, that contains pneumococcal polysaccharides (PnPs), which account for 74% to 94% of invasive pneumococcal disease in adults aged 65 years or older,” said Heather Platt, MD, clinical director with Merck Research Laboratories, who has been involved in the development of V116 for the past 5 years.
She explained that in regions with pediatric pneumococcal vaccination programs, largely, the burden of disease is greater in adults than in children, and many of the serotypes that cause disease in adults are not included in currently licensed vaccines.
“An example of how we think V116 can have an impact is in the United States, where the serotypes targeted by V116 account for 85% of all invasive pneumococcal disease in individuals aged 65 years and older as of 2019,” Platt said.
In the Phase 1 part of the study, the researchers enrolled generally healthy individuals aged 18 to 49 years—a population that typically has robust immune responses and allowed the researchers to understand the vaccine performance, both from an immunogenicity perspective, as well as a safety perspective.
In the Phase 2 part of the study, the researchers enrolled adults aged 50 year oor older, an important population to include as it is more consistent with the target population that is currently included in vaccination guidelines.
“The chief takeaways from the Phase 1/2 study are that V116 is well tolerated with a safety profile comparable to the Pneumococcal polysaccharide vaccine (PPSV23), and that vaccination with V116 resulted in robust immune responses for serotypes that are common to PPSV23, and also for serotypes that are unique to V116,” Platt said. “It is so important that we make our data available to health care providers. We are listening to those clinicians and scientists who are seeing and critically thinking about their patients. We understand that there is a substantial burden of disease due to Streptococcus pneumoniae, and we are approaching this unmet medical need by understanding the changing serotype epidemiology to have the right approach to disease prevention for adults.”
In talking with other clinicians and researchers, Platt was heartened at the opportunities to collaborate and share insights in improving public health.
“What happens next is actually what is happening now,” she said. “The results from the Phase 1/2 study support further development, and we currently have 5 Phase 3 studies that are currently enrolling participants to fully evaluate safety, tolerability, and immunogenicity of V116 in adults. Although the overall Phase 3 program is broad, we are focusing on the details. One of the important details is that we strive to enroll participants that represent the diversity of the countries that participate in the studies.”
1. Platt H, Omole T, Cardona J, et al. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in healthy adults: phase 1/2, randomised, double-blind, active comparator-controlled, multicentre, US-based trial. Lancet Infect Dis. 2022;S1473-3099(22)00526-6. doi:10.1016/S1473-3099(22)00526-6