218
Views
18
CrossRef citations to date
0
Altmetric
Vaccine Profile

Pneumococcal 13-valent conjugate vaccine for the prevention of invasive pneumococcal disease in children and adults

, , &
Pages 889-902 | Published online: 09 Jan 2014

References

  • Mulholland K. Global burden of acute respiratory infections in children: implications for interventions. Pediatr. Pulmonol. 36(6), 469–474 (2003).
  • O’Brien KL, Wolfson LJ, Watt JP et al.; Hib and Pneumococcal Global Burden of Disease Study Team. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet 374(9693), 893–902 (2009).
  • Johnson HL, Deloria-Knoll M, Levine OS et al. Systematic evaluation of serotypes causing invasive pneumococcal disease among children under five: the pneumococcal global serotype project. PLoS Med. 7(10), e1000348 (2010).
  • Melegaro A, Edmunds WJ, Pebody R, Miller E, George R. The current burden of pneumococcal disease in England and Wales. J. Infect. 52(1), 37–48 (2006).
  • Isaacman DJ, McIntosh ED, Reinert RR. Burden of invasive pneumococcal disease and serotype distribution among Streptococcus pneumoniae isolates in young children in Europe: impact of the 7-valent pneumococcal conjugate vaccine and considerations for future conjugate vaccines. Int. J. Infect. Dis. 14(3), e197–e209 (2010).
  • Tocheva AS, Jefferies JM, Rubery H et al. Declining serotype coverage of new pneumococcal conjugate vaccines relating to the carriage of Streptococcus pneumoniae in young children. Vaccine 29(26), 4400–4404 (2011).
  • Hanage WP, Bishop CJ, Huang SS et al. Carried pneumococci in Massachusetts children: the contribution of clonal expansion and serotype switching. Pediatr. Infect. Dis. J. 30(4), 302–308 (2010).
  • Granat SM, Mia Z, Ollgren J et al. Longitudinal study on pneumococcal carriage during the first year of life in Bangladesh. Pediatr. Infect. Dis. J. 26(4), 319–324 (2007).
  • Bouskraoui M, Soraa N, Zahlane K et al. [Study of nasopharyngeal colonization by Streptococcus pneumoniae and its antibiotics resistance in healthy children less than 2 years of age in the Marrakech region (Morocco)]. Arch. Pediatr. 18(12), 1265–1270 (2011).
  • Stein KE. Thymus-independent and thymus-dependent responses to polysaccharide antigens. J. Infect. Dis. 165(Suppl. 1), S49–S52 (1992).
  • Insel RA, Anderson PW. Oligosaccharide-protein conjugate vaccines induce and prime for oligoclonal IgG antibody responses to the Haemophilus influenzae b capsular polysaccharide in human infants. J. Exp. Med. 163(2), 262–269 (1986).
  • Miller E, Andrews NJ, Waight PA, Slack MP, George RC. Herd immunity and serotype replacement 4 years after seven-valent pneumococcal conjugate vaccination in England and Wales: an observational cohort study. Lancet Infect. Dis. 11(10), 760–768 (2011).
  • Whitney CG, Pilishvili T, Farley MM et al. Effectiveness of seven-valent pneumococcal conjugate vaccine against invasive pneumococcal disease: a matched case-control study. Lancet 368(9546), 1495–1502 (2006).
  • Rosen JB, Thomas AR, Lexau CA et al.; CDC Emerging Infections Program Network. Geographic variation in invasive pneumococcal disease following pneumococcal conjugate vaccine introduction in the United States. Clin. Infect. Dis. 53(2), 137–143 (2011).
  • Talbird SE, Taylor TN, Knoll S, Frostad CR, García Martí S. Outcomes and costs associated with PHiD-CV, a new protein D conjugate pneumococcal vaccine, in four countries. Vaccine 28(Suppl. 6), G23–G29 (2010).
  • De Wals P, Black S, Borrow R, Pearce D. Modeling the impact of a new vaccine on pneumococcal and nontypable Haemophilus influenzae diseases: a new simulation model. Clin. Ther. 31(10), 2152–2169 (2009).
  • Prymula R, Peeters P, Chrobok V et al. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet 367(9512), 740–748 (2006).
  • CDC. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children – Advisory Committee on Immunization Practices (ACIP). MMWR Morb. Mortal. Wkly Rep. 59(9), 258–261 (2010).
  • Jensch I, Gámez G, Rothe M et al. PavB is a surface-exposed adhesin of Streptococcus pneumoniae contributing to nasopharyngeal colonization and airways infections. Mol. Microbiol. 77(1), 22–43 (2010).
  • Hausdorff WP, Feikin DR, Klugman KP. Epidemiological differences among pneumococcal serotypes. Lancet Infect. Dis. 5(2), 83–93 (2005).
  • Jacobs MR, Good CE, Bajaksouzian S, Windau AR. Emergence of Streptococcus pneumoniae serotypes 19A, 6C, and 22F and serogroup 15 in Cleveland, Ohio, in relation to introduction of the protein-conjugated pneumococcal vaccine. Clin. Infect. Dis. 47(11), 1388–1395 (2008).
  • Pillai DR, Shahinas D, Buzina A et al. Genome-wide dissection of globally emergent multi-drug resistant serotype 19A Streptococcus pneumoniae. BMC Genomics 10, 642 (2009).
  • Cooper D, Yu X, Sidhu M, Nahm MH, Fernsten P, Jansen KU. The 13-valent pneumococcal conjugate vaccine (PCV13) elicits cross-functional opsonophagocytic killing responses in humans to Streptococcus pneumoniae serotypes 6C and 7A. Vaccine 29(41), 7207–7211 (2011).
  • Nahm MH, Lin J, Finkelstein JA, Pelton SI. Increase in the prevalence of the newly discovered pneumococcal serotype 6C in the nasopharynx after introduction of pneumococcal conjugate vaccine. J. Infect. Dis. 199(3), 320–325 (2009).
  • Tocheva AS, Jefferies JM, Christodoulides M, Faust SN, Clarke SC. Increase in serotype 6C pneumococcal carriage, United Kingdom. Emerging Infect. Dis. 16(1), 154–155 (2010).
  • Miller E, Andrews NJ, Waight PA, Slack MP, George RC. Effectiveness of the new serotypes in the 13-valent pneumococcal conjugate vaccine. Vaccine 29(49), 9127–9131 (2011).
  • Attal S, Bingen E, Bonnet E et al. Impact of 13-valent pneumococcal conjugate vaccine (PCV13) on nasopharyngeal (NP) flora in children with acute otitis media (AOM). Presented at: 51st International conference on Antimicrobial Agents and Chemotherapy (ICAAC), Chicago, IL, USA, 17–20 September 2011.
  • Balicer RD, Zarka S, Levine H et al. Control of Streptococcus pneumoniae serotype 5 epidemic of severe pneumonia among young army recruits by mass antibiotic treatment and vaccination. Vaccine 28(34), 5591–5596 (2010).
  • Gupta A, Khaw FM, Stokle EL et al. Outbreak of Streptococcus pneumoniae serotype 1 pneumonia in a United Kingdom school. BMJ 337, a2964 (2008).
  • Hausdorff WP, Bryant J, Paradiso PR, Siber GR. Which pneumococcal serogroups cause the most invasive disease: implications for conjugate vaccine formulation and use, part I. Clin. Infect. Dis. 30(1), 100–121 (2000).
  • Hausdorff WP. The roles of pneumococcal serotypes 1 and 5 in paediatric invasive disease. Vaccine 25(13), 2406–2412 (2007).
  • Gadzinowski J, Albrecht P, Hasiec B et al. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine 29(16), 2947–2955 (2011).
  • Yeh SH, Gurtman A, Hurley DC et al.; 004 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in infants and toddlers. Pediatrics 126(3), e493–e505 (2010).
  • Frenck R Jr, Thompson A, Yeh SH et al.; 3011 Study Group. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in children previously immunized with 7-valent pneumococcal conjugate vaccine. Pediatr. Infect. Dis. J. 30(12), 1086–1091 (2011).
  • Grimprel E, Laudat F, Patterson S et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine (PCV13) when given as a toddler dose to children immunized with PCV7 as infants. Vaccine 29(52), 9675–9683 (2011).
  • Schwarz TF, Flamaing J, Rümke HC et al. A randomized, double-blind trial to evaluate immunogenicity and safety of 13-valent pneumococcal conjugate vaccine given concomitantly with trivalent influenza vaccine in adults aged =65 years. Vaccine 29(32), 5195–5202 (2011).
  • Kieninger DM, Kueper K, Steul K et al.; 006 study group. Safety, tolerability, and immunologic noninferiority of a 13-valent pneumococcal conjugate vaccine compared to a 7-valent pneumococcal conjugate vaccine given with routine pediatric vaccinations in Germany. Vaccine 28(25), 4192–4203 (2010).
  • Huang LM, Lin TY, Juergens C. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine given with routine pediatric vaccines in Taiwan. Vaccine 30(12), 2054–2059 (2012).
  • Snape MD, Klinger CL, Daniels ED et al. Immunogenicity and reactogenicity of a 13-valent-pneumococcal conjugate vaccine administered at 2, 4, and 12 months of age: a double-blind randomized active-controlled trial. Pediatr. Infect. Dis. J. 29(12), e80–e90 (2010).
  • Nunes MC, Madhi SA. Review on the immunogenicity and safety of PCV-13 in infants and toddlers. Expert Rev. Vaccines 10(7), 951–980 (2011).
  • Gurtman A, Tansey SP, Thompson A et al. Safety of 13-valent pneumococcal conjugate vaccine in infants and children: meta-analysis of 13 clinical trials in 9 countries. Presented at: 28th European Society for Pediatric Infectious Diseases (ESPID) Annual Meeting, Nice, France, 4–8 May 2010.
  • Jódar L, Butler J, Carlone G et al. Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants. Vaccine 21(23), 3265–3272 (2003).
  • Feavers I, Knezevic I, Powell M, Griffiths E. Challenges in the evaluation and licensing of new pneumococcal vaccines, 7-8 July 2008, Ottawa, Canada. Vaccine 27(28), 3681–3688 (2009).
  • Huss A, Scott P, Stuck AE, Trotter C, Egger M. Efficacy of pneumococcal vaccination in adults: a meta-analysis. CMAJ 180(1), 48–58 (2009).
  • Lode H, Schmoele-Thoma B, Gruber et al. Dose-ranging study of a single injection of pneumococcal conjugate vaccine (1 ×, 2 ×, or 4 ×) in healthy subjects aged 70 years or older. Vaccine 29(31), 4940–4946 (2011).
  • Goldblatt D, Southern J, Andrews N et al. The immunogenicity of 7-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in adults aged 50-80 years. Clin. Infect. Dis. 49(9), 1318–1325 (2009).
  • Dransfield MT, Nahm MH, Han MK et al.; COPD Clinical Research Network. Superior immune response to protein-conjugate versus free pneumococcal polysaccharide vaccine in chronic obstructive pulmonary disease. Am. J. Respir. Crit. Care Med. 180(6), 499–505 (2009).
  • Scott DA, Komjathy SF, Hu BT et al. Phase 1 trial of a 13-valent pneumococcal conjugate vaccine in healthy adults. Vaccine 25(33), 6164–6166 (2007).
  • Jackson LA, Neuzil KM, Nahm MH et al. Immunogenicity of varying dosages of 7-valent pneumococcal polysaccharide-protein conjugate vaccine in seniors previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine 25(20), 4029–4037 (2007).
  • Musher DM, Manof SB, Liss C et al. Safety and antibody response, including antibody persistence for 5 years, after primary vaccination or revaccination with pneumococcal polysaccharide vaccine in middle-aged and older adults. J. Infect. Dis. 201(4), 516–524 (2010).
  • Musher DM, Rueda AM, Nahm MH, Graviss EA, Rodriguez-Barradas MC. Initial and subsequent response to pneumococcal polysaccharide and protein-conjugate vaccines administered sequentially to adults who have recovered from pneumococcal pneumonia. J. Infect. Dis. 198(7), 1019–1027 (2008).
  • de Roux A, Schmöle-Thoma B, Schmöele-Thoma B et al. Comparison of pneumococcal conjugate polysaccharide and free polysaccharide vaccines in elderly adults: conjugate vaccine elicits improved antibacterial immune responses and immunological memory. Clin. Infect. Dis. 46(7), 1015–1023 (2008).
  • Jackson L, Gurtman A, van Cleeff M et al. 13-valent pneumococcal conjugate vaccine (PCV13) enhances the response to subsequent PCV13 and 23-valent pneumococcal polysaccharide (PPSV23) vaccinations in adults 50 years and older. Presented at: Infectious Disease Society of America (IDSA) Annual Meeting, Boston, MA, USA, 20–23 October 2011.
  • Pilishvili T, Lexau C, Farley MM et al.; Active Bacterial Core Surveillance/Emerging Infections Program Network. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J. Infect. Dis. 201(1), 32–41 (2010).
  • Jansen AG, Rodenburg GD, de Greeff SC et al. Invasive pneumococcal disease in the Netherlands: syndromes, outcome and potential vaccine benefits. Vaccine 27(17), 2394–2401 (2009).
  • Weycker D, Strutton D, Edelsberg J, Sato R, Jackson LA. Clinical and economic burden of pneumococcal disease in older US adults. Vaccine 28(31), 4955–4960 (2010).
  • French N, Gordon SB, Mwalukomo Tet al. A trial of a 7-valent pneumococcal conjugate vaccine in HIV-infected adults. N. Engl. J. Med. 362(9), 812–822 (2010).
  • Goldblatt D, Southern J, Ashton L et al. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. Pediatr. Infect. Dis. J. 25(4), 312–319 (2006).
  • WHO. Pneumococcal conjugate vaccine for childhood immunization – WHO position paper. Wkly Epidemiol. Rec., 82(12), 93–104 (2007).
  • Jackson LA, Janoff EN. Pneumococcal vaccination of elderly adults: new paradigms for protection. Clin. Infect. Dis. 47(10), 1328–1338 (2008).
  • Gimenez-Sanchez F, Kieninger DM, Kueper K et al.; 501 and 006 study groups. Immunogenicity of a combination vaccine containing diphtheria toxoid, tetanus toxoid, three-component acellular pertussis, hepatitis B, inactivated polio virus, and Haemophilus influenzae type b when given concomitantly with 13-valent pneumococcal conjugate vaccine. Vaccine 29(35), 6042–6048 (2011).
  • Miller E, Andrews N, Waight P et al. Safety and immunogenicity of coadministering a combined meningococcal serogroup C and Haemophilus influenzae type b conjugate vaccine with 7-valent pneumococcal conjugate vaccine and measles, mumps, and rubella vaccine at 12 months of age. Clin. Vaccine Immunol. 18(3), 367–372 (2011).
  • Esposito S, Tansey S, Thompson A et al. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine compared to those of a 7-valent pneumococcal conjugate vaccine given as a three-dose series with routine vaccines in healthy infants and toddlers. Clin. Vaccine Immunol. 17(6), 1017–1026 (2010).
  • Rubin JL, McGarry LJ, Strutton DR et al. Public health and economic impact of the 13-valent pneumococcal conjugate vaccine (PCV13) in the United States. Vaccine 28(48), 7634–7643 (2011).
  • Boccalini S, Azzari C, Resti M et al. Economic and clinical evaluation of a catch-up dose of 13-valent pneumococcal conjugate vaccine in children already immunized with three doses of the 7-valent vaccine in Italy. Vaccine 29(51), 9521–9528 (2011).
  • Strutton DR, Farkouh RA, Earnshaw SR et al. Cost-effectiveness of 13-valent pneumococcal conjugate vaccine: Germany, Greece, and The Netherlands. J. Infect. 64(1), 54–67 (2012).
  • Robberstad B, Frostad CR, Akselsen PE, Kværner KJ, Berstad AK. Economic evaluation of second generation pneumococcal conjugate vaccines in Norway. Vaccine 29(47), 8564–8574 (2011).
  • Urueña A, Pippo T, Betelu MS et al. Cost–effectiveness analysis of the 10- and 13-valent pneumococcal conjugate vaccines in Argentina. Vaccine 29(31), 4963–4972 (2011).
  • Giglio N, Micone P, Gentile A. The pharmacoeconomics of pneumococcal conjugate vaccines in Latin America. Vaccine 29(Suppl. 3), C35–C42 (2011).
  • Kim SY, Lee G, Goldie SJ. Economic evaluation of pneumococcal conjugate vaccination in The Gambia. BMC Infect. Dis. 10, 260 (2010).
  • Jackson LA, Neuzil KM, Yu O et al.; Vaccine Safety Datalink. Effectiveness of pneumococcal polysaccharide vaccine in older adults. N. Engl. J. Med. 348(18), 1747–1755 (2003).
  • Smith KJ, Wateska AR, Nowalk MP, Raymund M, Nuorti JP, Zimmerman RK. Cost–effectiveness of adult vaccination strategies using pneumococcal conjugate vaccine compared with pneumococcal polysaccharide vaccine. JAMA 307(8), 804–812 (2012).
  • Black SBM, Shinefield HRM, Ling SMM et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Pediatr. Infect. Dis. J. 21(9), 810–815 (2002).
  • Hak E, Grobbee DE, Sanders EA et al. Rationale and design of CAPITA: a RCT of 13-valent conjugated pneumococcal vaccine efficacy among older adults. Neth. J. Med. 66(9), 378–383 (2008).
  • CDC. Invasive pneumococcal disease and 13-valent pneumococcal conjugate vaccine (PCV13) coverage among children aged </=59 months – selected U.S. regions, 2010–2011. MMWR Morb. Mortal. Wkly Rep. 60, 1477–1481 (2011).
  • Imöhl M, Rückinger S, Linden MVD, Kries RV. First Effects of Immunization with Higher Valent Pneumococcal Conjugate Vaccines in German Children on Numbers of Reported Invasive Pneumococcal Disease (IPD) Cases. Presented at: 51st International Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Chicago, IL, USA, 17–20 September 2011.
  • Shea KM, Weycker D, Stevenson AE, Strutton DR, Pelton SI. Modeling the decline in pneumococcal acute otitis media following the introduction of pneumococcal conjugate vaccines in the US. Vaccine 29(45), 8042–8048 (2011).
  • Brueggemann AB, Peto TE, Crook DW, Butler JC, Kristinsson KG, Spratt BG. Temporal and geographic stability of the serogroup-specific invasive disease potential of Streptococcus pneumoniae in children. J. Infect. Dis. 190(7), 1203–1211 (2004).
  • Flasche S, Van Hoek AJ, Sheasby E et al. Effect of pneumococcal conjugate vaccination on serotype-specific carriage and invasive disease in England: a cross-sectional study. PLoS Med. 8(4), e1001017 (2011).
  • Kaplan SL, Mason EO Jr, Wald ER et al. Decrease of invasive pneumococcal infections in children among 8 children’s hospitals in the United States after the introduction of the 7-valent pneumococcal conjugate vaccine. Pediatrics 113(3 Pt 1), 443–449 (2004).
  • Huang SS, Platt R, Rifas-Shiman SL, Pelton SI, Goldmann D, Finkelstein JA. Post-PCV7 changes in colonizing pneumococcal serotypes in 16 Massachusetts communities, 2001 and 2004. Pediatrics 116(3), e408–e413 (2005).
  • Saaka M, Okoko BJ, Kohberger RC et al. Immunogenicity and serotype-specific efficacy of a 9-valent pneumococcal conjugate vaccine (PCV-9) determined during an efficacy trial in The Gambia. Vaccine 26(29–30), 3719–3726 (2008).
  • Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle N, Pierce N ; Vaccine Trialists Group. A trial of a 9-valent pneumococcal conjugate vaccine in children with and those without HIV infection. N. Engl. J. Med. 349(14), 1341–1348 (2003).
  • Madhi SA, Adrian P, Kuwanda L, Cutland C, Albrich WC, Klugman KP. Long-term effect of pneumococcal conjugate vaccine on nasopharyngeal colonization by Streptococcus pneumoniae – and associated interactions with Staphylococcus aureus and Haemophilus influenzae colonization – in HIV-infected and HIV-uninfected children. J. Infect. Dis. 196(11), 1662–1666 (2007).
  • Klugman KP, Madhi SA, Adegbola RA, Cutts F, Greenwood B, Hausdorff WP. Timing of serotype 1 pneumococcal disease suggests the need for evaluation of a booster dose. Vaccine 29(18), 3372–3373 (2011).
  • Skinner JM, Indrawati L, Cannon J et al. Pre-clinical evaluation of a 15-valent pneumococcal conjugate vaccine (PCV15-CRM197) in an infant-rhesus monkey immunogenicity model. Vaccine 29(48), 8870–8876 (2011).
  • Hicks L, Harrison L, Flannery B et al. Incidence of pneumococcal disease due to non-pneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, 1998–2004. J. Infect. Dis. 196(9), 1346–1354 (2007).
  • Hogenesch H, Dunham A, Hansen B, Anderson K, Maisonneuve JF, Hem SL. Formulation of a killed whole cell pneumococcus vaccine – effect of aluminum adjuvants on the antibody and IL-17 response. J. Immune Based Ther. Vaccines 9, 5 (2011).
  • Lu Y-J, Leite L, Gonçalves VM et al. GMP-grade pneumococcal whole-cell vaccine injected subcutaneously protects mice from nasopharyngeal colonization and fatal aspiration-sepsis. Vaccine 28(47), 7468–7475 (2011).
  • Moschioni M, De Angelis G, Harfouche C et al. Immunization with the RrgB321 fusion protein protects mice against both high and low pilus-expressing Streptococcus pneumoniae populations. Vaccine 30(7), 1349–1356 (2012).
  • Cao J, Li D, Gong Y et al. Caseinolytic protease: a protein vaccine which could elicit serotype-independent protection against invasive pneumococcal infection. Clin. Exp. Immunol. 156(1), 52–60 (2009).
  • Olafsdottir TA, Lingnau K, Nagy E, Jonsdottir I. Novel protein-based pneumococcal vaccines administered with the Th1-promoting adjuvant IC31 induce protective immunity against pneumococcal disease in neonatal mice. Infect. Immun. 80(1), 461–468 (2012).
  • Murphy TF, Bakaletz LO, Smeesters PR. Microbial interactions in the respiratory tract. Pediatr. Infect. Dis. J. 28(Suppl. 10), S121–S126 (2009).
  • Jefferies JM, Clarke SC, Webb JS, Kraaijeveld AR. Risk of red queen dynamics in pneumococcal vaccine strategy. Trends Microbiol. 19(8), 377–381 (2011).

Websites

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.