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Published on: May 19, 2020
Current knowledge regarding the investigational 13-valent pneumococcal conjugate vaccine
Ener Cagri Dinleyici1, Zeynel Abidin Yargic
1Eskisehir Osmangazi University Faculty of Medicine, Department of Pediatrics, Eskisehir, TR-26480 Turkey. timboothtr@yahoo.com
Insights
The 13-valent pneumococcal conjugate vaccine (PCV-13) shows promise in preventing invasive pneumococcal disease (IPD) by covering additional serotypes. Further studies are needed to assess its long-term effectiveness and optimal use with PCV-7.
Area of Science:
- * Pediatric infectious diseases
- * Vaccinology and immunology
- * Epidemiological surveillance
Background:
- * The 7-valent pneumococcal conjugate vaccine (PCV-7) has reduced invasive pneumococcal disease (IPD), pneumonia, otitis media, and meningitis in children.
- * IPD cases caused by non-PCV-7 serotypes are increasing, with some serotypes posing significant global health burdens.
- * Specific serotypes (1, 5, 7F, 6A, 19A) are associated with higher morbidity and mortality in certain regions.
Purpose of the Study:
- * To evaluate the safety and immunogenicity of an investigational 13-valent pneumococcal conjugate vaccine (PCV-13).
- * To assess PCV-13's potential to broaden protection against a wider range of pneumococcal serotypes causing IPD globally.
- * To compare PCV-13's immune responses with those of the current PCV-7.
Main Methods:
- * Clinical trials assessing safety and tolerability of PCV-13 when co-administered with other pediatric vaccines.
- * Immunogenicity studies measuring IgG anticapsular polysaccharide-binding concentrations.
- * Opsonophagocytic assay (OPA) to evaluate functional antibody responses.
Main Results:
- * PCV-13 demonstrated safety and good tolerability in infants during clinical trials.
- * Immunogenicity studies showed non-inferior and comparable IgG and OPA responses between PCV-13 and PCV-7.
- * PCV-13 elicits immune responses against six additional serotypes, enhancing potential protection against a broader spectrum of IPD.
Conclusions:
- * PCV-13 is safe, well-tolerated, and immunogenic in infants, offering potential for broader protection against IPD.
- * The vaccine's ability to cover emerging and globally relevant serotypes makes it a promising candidate for reducing pneumococcal disease burden worldwide.
- * Further research is required to determine optimal scheduling, duration, and combination strategies with PCV-7, alongside post-licensure effectiveness studies.
Abstract:
The introduction of a 7-valent pneumococcal conjugate vaccine (PCV-7) into the routine childhood vaccination schedule has been shown to be effective in preventing invasive pneumococcal disease (IPD), pneumonia, otitis media and meningitis in infants and young children as determined by epidemiological surveillance studies. There has been a rise in IPD due to nonvaccine serotypes; however, this rise is small compared with the overall reduction in IPD. Non-PCV-7 serotypes and vaccine-related serotypes, such as serotypes 1, 5, 7F, 6A and 19A, have also been reported to cause IPD in some parts of the world where morbidity and mortality from pneumococcal disease are higher. An investigational 13-valent pneumococcal conjugate vaccine (PCV-13) uses CRM(197) as a carrier, similar to the current PCV-7, and covers serotypes 1, 3, 5, 6A, 7F and 19A, in addition to the serotypes of PCV-7 (serotype 4, 6B, 9V, 14, 18C, 19F and 23F). PCV-13 is safe and well tolerated with other pediatric vaccines in infants according to clinical trials. IgG anticapsular polysaccharide-binding concentrations and opsonophagocytic assay responses are similar and noninferior between PCV-13 and PCV-7 and, according to immunogenicity studies, PCV-13 has more potential to protect against pneumococcal diseases with the additional six serotypes. With the addition of these new serotypes, it could be possible to cover potential pneumococcal serotypes causing IPD throughout the world. The cost of the vaccine, its length of duration, optimal scheduling, combination and boosting with PCV-7 are still unresolved issues. Assessment of the vaccine's effectiveness and efficacy following potential licensure will require carefully designed cohort and case-control studies that can assess the indirect effects of PCV-13.
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