New results from STRIDE-8 (NCT05696080), a phase 3 trial evaluating the pneumococcal 21-valent conjugate vaccine (PCV21; Capvaxie), were presented at IDWeek 2024, demonstrating the vaccine’s efficacy in adults aged 18-64. Proven. People who have not previously received a pneumococcal vaccine are at risk for pneumococcal disease. 1, 2
The positive results, announced in a Merck news release last week, further highlight the vaccine’s strong immunogenic properties. In this study, PCV21 was immunogenic against all 21 strains included at day 30. Furthermore, the immune response was comparable to that produced by the combination of pneumococcal 15-valent conjugate vaccine (PCV15) and pneumococcal 23-valent polysaccharide vaccine (PPSV23). 1
The pneumococcal 21-valent conjugate vaccine has already been approved by the FDA and recommended by the CDC for disease prevention in adults. |Image credit: © Alexey Novikov |Stock.Adobe.com
“Adults with chronic medical conditions, such as kidney disease or diabetes, are particularly susceptible to invasive pneumococcal infections and are at risk of severe illness,” Walter Orenstein, M.D., a member of Merck’s Scientific Advisory Board, said in a news release. “There is a possibility that the risk of deterioration may increase.” “These data further demonstrate that the broad serotype coverage offered by Capvaxie can help prevent invasive disease in vulnerable adults.”
In June, the FDA granted regulatory approval to a vaccine for the prevention of pneumococcal disease and pneumonia in people 18 and older. Serotypes eligible for vaccination include 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31 , 33F, 35B included. Invasive disease indications. 3
Following approval in the United States, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommends the vaccine to eligible adults age 65 and older who have not previously received a vaccine or whose vaccination history is unknown. It was unanimously resolved. It also recommended that adults ages 19 to 64 with certain risk factors get vaccinated. 4
STRIDE-8 trial investigators also collected important safety data, with lower rates of adverse events (AEs) experienced in patients receiving PCV21 compared to patients receiving PCV15 and PPSV23. These include injection site, systemic and vaccine-related AEs. 1
About the trial
Study Name: Safety and Immunogenicity of V116 in Adults at Increased Risk of Pneumococcal Disease (V116-008) (STRIDE-8)
ClinicalTrials.gov ID: NCT05696080
Sponsor: Merck Sharp & Dohme LLC
Completion date: February 16, 2024
During their IDWeek presentation, researchers also presented key findings from a targeted literature review on the clinical and economic burden of pneumococcal disease in adults nationwide. According to this review, black adults and rural adults with lower levels of education face lower pneumococcal vaccination rates and increased disease burden. 1
Results from modeling studies comparing PCV21 and pneumococcal 20-valent conjugate vaccine (PCV20) with respect to health effects in U.S. adults were also highlighted. The data showed that the use of PCV21 reduced the overall number of cases of pneumococcal disease compared to PCV20 after 10 years, with a 33.9% reduction across all ages compared to a 28.9% reduction for PCV20. This reduction equates to 14,000 fewer cases of pneumococcal disease. 1
“The data presented during IDWeek builds on the robust clinical profile of CAPVAXIVE and demonstrates the importance of improving equitable access for people at high risk for invasive pneumococcal disease.” said Makaya Duogui, M.D., director of the Vaccine Clinical Research Therapeutic Area. News release.1
References 1. Merck. Merck’s Capvaxie (pneumococcal 21-valent conjugate vaccine) shows positive immune responses in adults at high risk for pneumococcal disease. News release. Released on October 16, 2024. Accessed October 16, 2024. Increased risk of pneumococcal disease/2. ClinicalTrials.gov. Safety and immunogenicity of V116 in adults at increased risk of pneumococcal disease (V116-008) (STRIDE-8). National Library of Medicine. Last updated on February 28, 2024. Accessed October 16, 2024. https://clinicaltrials.gov/study/NCT056960803. Gallagher A. FDA has approved V116 for the prevention of invasive pneumococcal disease and pneumonia. Pharmacy Times. Published June 18, 2024. Accessed October 16, 2024. https://www.pharmacytimes.com/view/fda-approves-v116-for-prevention-of-invasive-pneumococcal-disease-and-pneumonia4. Halpern L. ACIP votes to recommend pneumococcal 21-valent conjugate vaccine for adults. Pharmacy Times. Published on July 2, 2024. Accessed October 16, 2024.
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