PCV21 Demonstrates Robust Immune Response in Children and Adolescents
Investigators at the 6th European Society of Clinical Microbiology and Infectious Diseases Conference on Vaccines in Lisbon, Portugal, have unveiled positive results from the phase 3 STRIDE-13 clinical trial (NCT06177912). The 21-valent pneumococcal conjugate vaccine (PCV21, Capvaxive; Merck) administered to high-risk children and adolescents aged 2 to less than 18 years who had previously completed a pneumococcal vaccine series demonstrated robust immune responses and noninferiority to the pneumococcal 23-valent polysaccharide vaccine (PPSV23), according to a news release from Merck.12
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PCV21 was specifically designed to target serotypes causing most of the invasive pneumococcal disease (IPD) cases in adults, according to Paula Annunziato, senior vice president of infectious diseases and vaccines at Merck Research laboratories. It is indeed indicated for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals aged 18 and older. Even though the STRIDE family of trials has affirmed PCV21S effectiveness in adults, its potential in children had remained unknown until now.1
“While [PCV21] was designed to specifically cover the serotypes that cause the majority of IPD cases in adults,findings from STRIDE-13 underscore its added potential to help protect children and adolescents who are at an increased risk,” Annunziato said in the news release.1
Results of STRIDE-13 Show Immunogenicity in Younger Individuals
In STRIDE-13, a phase 3, randomized, double-blind, active comparator-controlled clinical trial, investigators evaluated the immunogenicity, safety, and tolerability of PCV21 compared with PPSV23 specifically in young patients with increased pneumococcal disease risk. A series of medical conditions can put patients at heightened risk for IPD, including diabetes, chronic liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease.