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PCV13: proven efficacy and safety
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Highlights of the 6th World Congress of the WSPID / International Journal of Infectious Diseases 14S (2010) e3–e10
18. Hortal M, Sehabiague G, Camou T, et al. Pneumococcal pneumonia in hospitalized Uruguayan children and potential prevention with different vaccine formulations. J Pediatr 2008;152:850–3. 19. Fenoll A, Gimenez MJ, Vicioso MD, et al. Trends of prevalent pneumococcal serotypes among adult invasive isolates pre- and post-licensure of 7-PCV for children in Spain. Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 260. 20. Fenoll A, Aguilar L, Vicioso MD, et al. Serotype 19A prevalence among Spanish Streptococcus pneumoniae invasive isolates (1997–2008) and its susceptibility to penicillin (pen)/cefotaxime (ctx) and erythromycin (ery). Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 213. 21. Brandileone MC, Brandão A, Almeida S, et al. Streptococcus pneumoniae invasive disease in Latin American and Caribbean Region: Laboratorial Surveillance Network (SIREVA II, PAHO/WHO). Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 584. 22. Murad C, Agustian D, de Gouveia L, et al. Serotype distribution and antimicrobial resistance of nasopharyngeal pneumococci among children <5 years with non-severe pneumonia in Bandung, Indonesia, 2002–2003. Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 346. 23. Mendez D, de Bolanos R. Nasopharyngeal carriage of Streptococcus pneumoniae in healthy children attending daycare centers in Panama. Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 271. ˜ R, Quinzada M. Serotype distribution and microbiological susceptibil24. Bolanos ity of Streptococcus pneumoniae causing invasive disease in children <5 years of age in Panama. Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 325. 25. Capeding MR, Brooks D, Hubler R, et al. Active hospital-based epidemiological surveillance of invasive pneumococcal disease (IPD) in children in Muntinlupa, Philippines. Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 749. 26. Dinleyici EC, Yargic ZA. Current knowledge regarding the investigational 13-valent pneumococcal conjugate vaccine. Expert Rev Vaccines 2009;8: 977–86.
doi:10.1016/j.ijid.2010.06.005 PCV13: proven efficacy and safety This discussion is based on a presentation given at a satellite symposium held in Buenos Aires, Argentina, on November 20, 2009, at the 6th World Congress of the World Society for Pediatric Infectious Diseases. Second-generation pneumococcal conjugate vaccines (PCVs), including 10-valent PCV and 13-valent PCV (PCV13), have recently been licensed in multiple countries worldwide. PCV13 is an oligosaccharide/polysaccharide capsular antigen conjugated with the nontoxic mutant protein CRM197 of diphtheria toxoid, the same carrier protein used in the 7-valent vaccine (PCV7). In addition to the 7 Streptococcus pneumoniae serotypes covered in PCV7 (4, 6B, 9 V, 14, 18C, 19F, and 23F), PCV13 also includes serotypes 1, 3, 5, 6A, 7F, and 19A. The inclusion of serotypes 6A and 19A in PCV13 will provide additional direct pediatric coverage, and serotypes 1, 3, 5, and 7F will provide additional otitis media coverage. Coverage of all of these serotypes will collectively provide generally improved global coverage against invasive pneumococcal disease (IPD). Studies conducted in Italy1 and Spain2 have demonstrated that the immunogenicity of PCV13 in a 2 + 1 schedule is comparable to that of PCV7. PCV7 administered in a 2 + 1 schedule has documented efficacy against IPD.3 Because PCV13 is designed to be interchangeable with PCV7 at any point in the immunization schedule, countries that are using PCV7 in the 2 + 1 schedule should be able to transition directly to PCV13. Furthermore, PCV13 was found to be noninferior to PCV7 when given concomitantly with most of the standard pediatric vaccines (Table 1), and it did not adversely affect the safety and/or immune responses of any of the coadministered vaccines.4–8
Table 1 Standard pediatric vaccines compatible with PCV13.4–8 Diphtheria Tetanus Acellular or whole cell pertussis Haemophilus influenzae type b Inactivated poliomyelitis Hepatitis B Meningococcal serogroup C Measles, mumps, and rubella Varicella PCV13 = 13-valent pneumococcal conjugate vaccine.
References 1. Esposito S, Tansey S, Thompson A, et al. Safety and immunologic non-inferiority of 13-valent pneumococcal conjugate vaccine given as a 3-dose series with routine vaccines in healthy children. Presented at: the 27th Annual Meeting of the European Society for Paediatric Infectious Diseases; June 9–13, 2009; Brussels, Belgium. 2. Diez-Domingo J, Gurtman A, Bernaola E, et al. Safety and immunogenicity of 13valent pneumococcal conjugate vaccine in healthy infants and toddlers receiving routine vaccinations in Spain. Presented at: the 27th Annual Meeting of the European Society for Paediatric Infectious Diseases; June 9–13, 2009; Brussels, Belgium. 3. Vestrheim DF, Løvoll O, Aaberge IS, et al. Effectiveness of a 2 + 1 dose schedule pneumococcal conjugate vaccination programme on invasive pneumococcal disease among children in Norway. Vaccine 2008;26:3277–81. 4. Kieninger DM, Kueper K, Steul K, et al. Safety and immunologic non-inferiority of 13-valent pneumococcal conjugate vaccine compared to 7-valent pneumococcal conjugate vaccine given with routine vaccines in healthy infants. Presented at: the 48th Annual ICAAC/IDSA 46th Annual Meeting; October 25–28, 2008; Washington, DC. 5. Klinger C, Snape MD, John T, et al. Immunogenicity of DTaP-IPV-Hib and MenC vaccines in the UK when administered with a 13-valent pneumococcal conjugate vaccine. Presented at: the 48th Annual ICAAC/IDSA 46th Annual Meeting; October 25–28, 2008; Washington, DC. 6. Grimprel E, Scott D, Laudat F, Baker S, Gruber W; for the PCV13 Multicenter Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccination to healthy infants in France. Presented at: the 48th Annual ICAAC/IDSA 46th Annual Meeting; October 25–28, 2008; Washington, DC. 7. Bryant KA, Gurtman A, Girgenti D, et al. Antibody responses to routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine. Presented at: the IDSA 47th Annual Meeting; October 29-November 1, 2009; Philadelphia, PA. Abstract 1195. 8. Gimenez-Sanchez F, Kieninger DM, Kueper K, et al. Immunogenicity of Infanrix hexa antigens when given concomitantly with 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers. Presented at: the IDSA 47th Annual Meeting; October 29-November 1, 2009; Philadelphia, PA. Abstract 1194.
doi:10.1016/j.ijid.2010.06.006 Preventing pneumococcal disease in adults This discussion is based on a presentation given at a satellite symposium held in Buenos Aires, Argentina, on November 20, 2009, at the 6th World Congress of the World Society for Pediatric Infectious Diseases. Pneumococcal infection accounts for about 500,000 cases of pneumonia each year in the United States and is associated with considerable morbidity and mortality.1 Pneumonia symptoms (i.e., fever, myalgia, dyspnea, cough, and fatigue) tend to persist, with median times to resolution ranging from 3 days for fever to 14 days for cough and fatigue; 35% of patients have ≥1 unresolved symptom at day 28.2 The 30-day mortality rate among patients with pneumococcal pneumonia admitted to the intensive care unit remains high compared with that of patients admitted to the general ward (23% vs 4%, respectively; P < 0.001).3 The 23-valent pneumococcal polysaccharide vaccines (PPSVs) currently available were licensed in 1983, replacing the earlier 14-valent formulation that was licensed in 1977.1 The Centers for Disease Control and Prevention Advisory Committee on Immu-
Highlights of the 6th World Congress of the WSPID / International Journal of Infectious Diseases 14S (2010) e3–e10
18. Hortal M, Sehabiague G, Camou T, et al. Pneumococcal pneumonia in hospitalized Uruguayan children and potential prevention with different vaccine formulations. J Pediatr 2008;152:850–3. 19. Fenoll A, Gimenez MJ, Vicioso MD, et al. Trends of prevalent pneumococcal serotypes among adult invasive isolates pre- and post-licensure of 7-PCV for children in Spain. Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 260. 20. Fenoll A, Aguilar L, Vicioso MD, et al. Serotype 19A prevalence among Spanish Streptococcus pneumoniae invasive isolates (1997–2008) and its susceptibility to penicillin (pen)/cefotaxime (ctx) and erythromycin (ery). Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 213. 21. Brandileone MC, Brandão A, Almeida S, et al. Streptococcus pneumoniae invasive disease in Latin American and Caribbean Region: Laboratorial Surveillance Network (SIREVA II, PAHO/WHO). Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 584. 22. Murad C, Agustian D, de Gouveia L, et al. Serotype distribution and antimicrobial resistance of nasopharyngeal pneumococci among children <5 years with non-severe pneumonia in Bandung, Indonesia, 2002–2003. Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 346. 23. Mendez D, de Bolanos R. Nasopharyngeal carriage of Streptococcus pneumoniae in healthy children attending daycare centers in Panama. Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 271. ˜ R, Quinzada M. Serotype distribution and microbiological susceptibil24. Bolanos ity of Streptococcus pneumoniae causing invasive disease in children <5 years of age in Panama. Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 325. 25. Capeding MR, Brooks D, Hubler R, et al. Active hospital-based epidemiological surveillance of invasive pneumococcal disease (IPD) in children in Muntinlupa, Philippines. Presented at: the 6th World Congress of the World Society for Pediatric Infectious Diseases; November 19–22, 2009; Buenos Aires, Argentina. Abstract 749. 26. Dinleyici EC, Yargic ZA. Current knowledge regarding the investigational 13-valent pneumococcal conjugate vaccine. Expert Rev Vaccines 2009;8: 977–86.
doi:10.1016/j.ijid.2010.06.005 PCV13: proven efficacy and safety This discussion is based on a presentation given at a satellite symposium held in Buenos Aires, Argentina, on November 20, 2009, at the 6th World Congress of the World Society for Pediatric Infectious Diseases. Second-generation pneumococcal conjugate vaccines (PCVs), including 10-valent PCV and 13-valent PCV (PCV13), have recently been licensed in multiple countries worldwide. PCV13 is an oligosaccharide/polysaccharide capsular antigen conjugated with the nontoxic mutant protein CRM197 of diphtheria toxoid, the same carrier protein used in the 7-valent vaccine (PCV7). In addition to the 7 Streptococcus pneumoniae serotypes covered in PCV7 (4, 6B, 9 V, 14, 18C, 19F, and 23F), PCV13 also includes serotypes 1, 3, 5, 6A, 7F, and 19A. The inclusion of serotypes 6A and 19A in PCV13 will provide additional direct pediatric coverage, and serotypes 1, 3, 5, and 7F will provide additional otitis media coverage. Coverage of all of these serotypes will collectively provide generally improved global coverage against invasive pneumococcal disease (IPD). Studies conducted in Italy1 and Spain2 have demonstrated that the immunogenicity of PCV13 in a 2 + 1 schedule is comparable to that of PCV7. PCV7 administered in a 2 + 1 schedule has documented efficacy against IPD.3 Because PCV13 is designed to be interchangeable with PCV7 at any point in the immunization schedule, countries that are using PCV7 in the 2 + 1 schedule should be able to transition directly to PCV13. Furthermore, PCV13 was found to be noninferior to PCV7 when given concomitantly with most of the standard pediatric vaccines (Table 1), and it did not adversely affect the safety and/or immune responses of any of the coadministered vaccines.4–8
Table 1 Standard pediatric vaccines compatible with PCV13.4–8 Diphtheria Tetanus Acellular or whole cell pertussis Haemophilus influenzae type b Inactivated poliomyelitis Hepatitis B Meningococcal serogroup C Measles, mumps, and rubella Varicella PCV13 = 13-valent pneumococcal conjugate vaccine.
References 1. Esposito S, Tansey S, Thompson A, et al. Safety and immunologic non-inferiority of 13-valent pneumococcal conjugate vaccine given as a 3-dose series with routine vaccines in healthy children. Presented at: the 27th Annual Meeting of the European Society for Paediatric Infectious Diseases; June 9–13, 2009; Brussels, Belgium. 2. Diez-Domingo J, Gurtman A, Bernaola E, et al. Safety and immunogenicity of 13valent pneumococcal conjugate vaccine in healthy infants and toddlers receiving routine vaccinations in Spain. Presented at: the 27th Annual Meeting of the European Society for Paediatric Infectious Diseases; June 9–13, 2009; Brussels, Belgium. 3. Vestrheim DF, Løvoll O, Aaberge IS, et al. Effectiveness of a 2 + 1 dose schedule pneumococcal conjugate vaccination programme on invasive pneumococcal disease among children in Norway. Vaccine 2008;26:3277–81. 4. Kieninger DM, Kueper K, Steul K, et al. Safety and immunologic non-inferiority of 13-valent pneumococcal conjugate vaccine compared to 7-valent pneumococcal conjugate vaccine given with routine vaccines in healthy infants. Presented at: the 48th Annual ICAAC/IDSA 46th Annual Meeting; October 25–28, 2008; Washington, DC. 5. Klinger C, Snape MD, John T, et al. Immunogenicity of DTaP-IPV-Hib and MenC vaccines in the UK when administered with a 13-valent pneumococcal conjugate vaccine. Presented at: the 48th Annual ICAAC/IDSA 46th Annual Meeting; October 25–28, 2008; Washington, DC. 6. Grimprel E, Scott D, Laudat F, Baker S, Gruber W; for the PCV13 Multicenter Study Group. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccination to healthy infants in France. Presented at: the 48th Annual ICAAC/IDSA 46th Annual Meeting; October 25–28, 2008; Washington, DC. 7. Bryant KA, Gurtman A, Girgenti D, et al. Antibody responses to routine pediatric vaccines when administered with 13-valent pneumococcal conjugate vaccine. Presented at: the IDSA 47th Annual Meeting; October 29-November 1, 2009; Philadelphia, PA. Abstract 1195. 8. Gimenez-Sanchez F, Kieninger DM, Kueper K, et al. Immunogenicity of Infanrix hexa antigens when given concomitantly with 13-valent pneumococcal conjugate vaccine in healthy infants and toddlers. Presented at: the IDSA 47th Annual Meeting; October 29-November 1, 2009; Philadelphia, PA. Abstract 1194.
doi:10.1016/j.ijid.2010.06.006 Preventing pneumococcal disease in adults This discussion is based on a presentation given at a satellite symposium held in Buenos Aires, Argentina, on November 20, 2009, at the 6th World Congress of the World Society for Pediatric Infectious Diseases. Pneumococcal infection accounts for about 500,000 cases of pneumonia each year in the United States and is associated with considerable morbidity and mortality.1 Pneumonia symptoms (i.e., fever, myalgia, dyspnea, cough, and fatigue) tend to persist, with median times to resolution ranging from 3 days for fever to 14 days for cough and fatigue; 35% of patients have ≥1 unresolved symptom at day 28.2 The 30-day mortality rate among patients with pneumococcal pneumonia admitted to the intensive care unit remains high compared with that of patients admitted to the general ward (23% vs 4%, respectively; P < 0.001).3 The 23-valent pneumococcal polysaccharide vaccines (PPSVs) currently available were licensed in 1983, replacing the earlier 14-valent formulation that was licensed in 1977.1 The Centers for Disease Control and Prevention Advisory Committee on Immu-