Advertisement

Drugs

, Volume 75, Issue 13, pp 1535–1546 | Cite as

13-Valent Pneumococcal Conjugate Vaccine: A Review of Its Use in Adults

  • Greg L. PloskerEmail author
Adis Drug Evaluation

Abstract

The 13-valent pneumococcal conjugate vaccine (Prevenar 13®, Prevnar 13®) [PCV13] consists of 13 serotype-specific polysaccharides of Streptococcus pneumoniae (pneumococcus), each covalently conjugated to a non-toxic immunogenic carrier protein. PCV13 has a well established immunogenicity and tolerability profile in adults, particularly those ≥50 years of age. Results of CAPiTA, a randomized, double-blind, placebo-controlled trial in >84,000 older adults aged ≥65 years, showed that PCV13 was effective in preventing vaccine-type pneumococcal community-acquired pneumonia (CAP), vaccine-type pneumococcal nonbacteraemic (noninvasive) CAP and vaccine-type invasive pneumococcal disease (IPD). These findings, along with changes in pneumococcal serotype distribution and epidemiology of pneumococcal disease, prompted the US Advisory Committee on Immunization Practices (ACIP) to recommend PCV13 in series with 23-valent pneumococcal polysaccharide vaccine (PPVS23) for all adults aged ≥65 years. PCV13 also has a role in preventing pneumococcal disease (pneumonia and IPD) in younger adults with immunocompromising conditions and potentially in those with other underlying medical conditions that increase the risk of pneumococcal disease.

Keywords

Invasive Pneumococcal Disease Pneumococcal Disease Pneumococcal Pneumonia Inactivate Influenza Vaccine Trivalent Inactivate Influenza Vaccine 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgments

During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes based on any comments received were made by the author on the basis of scientific and editorial merit.

Compliance with Ethical Standards

Funding

The preparation of this review was not supported by any external funding.

Conflicts of interest

Greg Plosker is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.

References

  1. 1.
    Kim DK, Bridges CB, Harriman KH. Advisory Committee on Immunization Practices recommended immunization schedule for adults aged 19 years or older: United States, 2015. Ann Intern Med. 2015;162(3):214–23.CrossRefGoogle Scholar
  2. 2.
    Centers for Disease Control Prevention. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine for adults with immunocompromising conditions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2012;61(40):816–9.Google Scholar
  3. 3.
    World Health Organization. Pneumococcal disease. http://www.who.int/ith/diseases/pneumococcal/en/. Accessed 7 Apr 2015.
  4. 4.
    Lynch JP 3rd, Zhanel GG. Streptococcus pneumoniae: epidemiology and risk factors, evolution of antimicrobial resistance, and impact of vaccines. Curr Opin Pulm Med. 2010;16(3):217–25.PubMedGoogle Scholar
  5. 5.
    Said MA, Johnson HL, Nonyane BA, et al. Estimating the burden of pneumococcal pneumonia among adults: a systematic review and meta-analysis of diagnostic techniques. PLoS One. 2013;8(4):e60273.PubMedCentralCrossRefPubMedGoogle Scholar
  6. 6.
    Lexau CA, Lynfield R, Danila R, et al. Changing epidemiology of invasive pneumococcal disease among older adults in the era of pediatric pneumococcal conjugate vaccine. JAMA. 2005;294(16):2043–51.CrossRefPubMedGoogle Scholar
  7. 7.
    van der Poll T, Opal SM. Pathogenesis, treatment, and prevention of pneumococcal pneumonia. Lancet. 2009;374(9700):1543–56.CrossRefPubMedGoogle Scholar
  8. 8.
    Muhammad RD, Oza-Frank R, Zell E, et al. Epidemiology of invasive pneumococcal disease among high-risk adults since the introduction of pneumococcal conjugate vaccine for children. Clin Infect Dis. 2013;56(5):e59–67.CrossRefPubMedGoogle Scholar
  9. 9.
    Shea KM, Edelsberg J, Weycker D, et al. Rates of pneumococcal disease in adults with chronic medical conditions. Open Forum Infect Dis. 2014;1(1):ofu024.PubMedCentralCrossRefPubMedGoogle Scholar
  10. 10.
    Jackson LA, Neuzil KM, Yu O, et al. Effectiveness of pneumococcal polysaccharide vaccine in older adults. N Engl J Med. 2003;348(18):1747–55.CrossRefPubMedGoogle Scholar
  11. 11.
    Honkanen PO, Keistinen T, Miettinen L, et al. Incremental effectiveness of pneumococcal vaccine on simultaneously administered influenza vaccine in preventing pneumonia and pneumococcal pneumonia among persons aged 65 years or older. Vaccine. 1999;17(20–21):2493–500.CrossRefPubMedGoogle Scholar
  12. 12.
    Huss A, Scott P, Stuck AE, et al. Efficacy of pneumococcal vaccination in adults: a meta-analysis. CMAJ. 2009;180(1):48–58.PubMedCentralCrossRefPubMedGoogle Scholar
  13. 13.
    Mangtani P, Cutts F, Hall AJ. Efficacy of polysaccharide pneumococcal vaccine in adults in more developed countries: the state of the evidence. Lancet Infect Dis. 2003;3(2):71–8.CrossRefPubMedGoogle Scholar
  14. 14.
    Conaty S, Watson L, Dinnes J, et al. The effectiveness of pneumococcal polysaccharide vaccines in adults: a systematic review of observational studies and comparison with results from randomised controlled trials. Vaccine. 2004;22(23–24):3214–24.CrossRefPubMedGoogle Scholar
  15. 15.
    Moberley S, Holden J, Tatham DP, et al. Vaccines for preventing pneumococcal infection in adults. Cochrane Database Syst Rev. 2013;1:Cd000422.PubMedGoogle Scholar
  16. 16.
    Russell KL, Baker CI, Hansen C, et al. Lack of effectiveness of the 23-valent polysaccharide pneumococcal vaccine in reducing all-cause pneumonias among healthy young military recruits: a randomized, double-blind, placebo-controlled trial. Vaccine. 2015;33(9):1182–7.CrossRefPubMedGoogle Scholar
  17. 17.
    Leventer-Roberts M, Feldman BS, Brufman I, et al. Effectiveness of 23-valent pneumococcal polysaccharide vaccine against invasive disease and hospital-treated pneumonia among people aged ≥65 years: a retrospective case-control study. Clin Infect Dis. 2015. doi: 10.1093/cid/civ096.
  18. 18.
    Jackson LA, Janoff EN. Pneumococcal vaccination of elderly adults: new paradigms for protection. Clin Infect Dis. 2008;47(10):1328–38.CrossRefPubMedGoogle Scholar
  19. 19.
    Leinonen M, Sakkinen A, Kalliokoski R, et al. Antibody response to 14-valent pneumococcal capsular polysaccharide vaccine in pre-school age children. Pediatr Infect Dis. 1986;5(1):39–44.CrossRefPubMedGoogle Scholar
  20. 20.
    Goldblatt D. Conjugate vaccines. Clin Exp Immunol. 2000;119(1):1–3.PubMedCentralCrossRefPubMedGoogle Scholar
  21. 21.
    Pfizer Inc. Prevnar 13 (pneumococcal 13-valent conjugate vaccine): US prescribing information. 2015. http://labeling.pfizer.com/showlabeling.aspx?id=501. Accessed 27 July 2015.
  22. 22.
    Prevenar 13 suspension for injection: summary of product characteristics (updated 10 Mar 2015). https://www.medicines.org.uk/emc/history/22689. Accessed 27 July 2015.
  23. 23.
    Sanford M. Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed): in older adults. Drugs. 2012;72(9):1243–55.CrossRefPubMedGoogle Scholar
  24. 24.
    Jackson LA, Gurtman A, Rice K, et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults 70 years of age and older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Vaccine. 2013;31(35):3585–93.CrossRefPubMedGoogle Scholar
  25. 25.
    Schwarz TF, Flamaing J, Rumke 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. 2011;29(32):5195–202.CrossRefPubMedGoogle Scholar
  26. 26.
    Greenberg RN, Gurtman A, Frenck RW, et al. Sequential administration of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults 60–64 years of age. Vaccine. 2014;32(20):2364–74.CrossRefPubMedGoogle Scholar
  27. 27.
    Jackson LA, Gurtman A, van Cleeff M, et al. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine compared to a 23-valent pneumococcal polysaccharide vaccine in pneumococcal vaccine-naive adults. Vaccine. 2013;31(35):3577–84.CrossRefPubMedGoogle Scholar
  28. 28.
    Frenck RW Jr, Gurtman A, Rubino J, et al. Randomized, controlled trial of a 13-valent pneumococcal conjugate vaccine administered concomitantly with an influenza vaccine in healthy adults. Clin Vaccine Immunol. 2012;19(8):1296–303.PubMedCentralCrossRefPubMedGoogle Scholar
  29. 29.
    Jackson LA, Gurtman A, van Cleeff M, et al. Influence of initial vaccination with 13-valent pneumococcal conjugate vaccine or 23-valent pneumococcal polysaccharide vaccine on anti-pneumococcal responses following subsequent pneumococcal vaccination in adults 50 years and older. Vaccine. 2013;31(35):3594–602.CrossRefPubMedGoogle Scholar
  30. 30.
    Tinoco JC, Juergens C, Ruiz Palacios GM, et al. Open-label trial of immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine in adults ≥50 years of age in Mexico. Clin Vaccine Immunol. 2015;22(2):185–92.PubMedCentralCrossRefPubMedGoogle Scholar
  31. 31.
    Glesby MJ, Watson W, Brinson C, et al. Immunogenicity and safety of 13-valent pneumococcal conjugate vaccine in HIV-infected adults previously vaccinated with pneumococcal polysaccharide vaccine. J Infect Dis. 2015;212(1):18–27.CrossRefPubMedGoogle Scholar
  32. 32.
    Bhorat AE, Madhi SA, Laudat F, et al. Immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine in HIV-infected individuals naive to pneumococcal vaccination. AIDS. 2015;29:1345–54.PubMedCentralCrossRefPubMedGoogle Scholar
  33. 33.
    Bonten MJM, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults [plus supplementary appendix]. N Engl J Med. 2015;372(12):1114–25.CrossRefPubMedGoogle Scholar
  34. 34.
    Plosker GL. 13-valent pneumococcal conjugate vaccine: a review of its use in infants, children, and adolescents. Paediatr Drugs. 2013;15(5):403–23.CrossRefPubMedGoogle Scholar
  35. 35.
    Simonsen L, Taylor RJ, Schuck-Paim C, et al. Effect of 13-valent pneumococcal conjugate vaccine on admissions to hospital 2 years after its introduction in the USA: a time series analysis. Lancet Respir Med. 2014;2(5):387–94.CrossRefPubMedGoogle Scholar
  36. 36.
    Moore MR, Link-Gelles R, Schaffner W, et al. Effect of use of 13-valent pneumococcal conjugate vaccine in children on invasive pneumococcal disease in children and adults in the USA: analysis of multisite, population-based surveillance. Lancet Infect Dis. 2015;15(3):301–9.CrossRefPubMedGoogle Scholar
  37. 37.
    von Gottberg A, de Gouveia L, Tempia S, et al. Effects of vaccination on invasive pneumococcal disease in South Africa. N Engl J Med. 2014;371(20):1889–99.CrossRefGoogle Scholar
  38. 38.
    Harboe ZB, Dalby T, Weinberger DM, et al. Impact of 13-valent pneumococcal conjugate vaccination in invasive pneumococcal disease incidence and mortality. Clin Infect Dis. 2014;59(8):1066–73.CrossRefPubMedGoogle Scholar
  39. 39.
    Regev-Yochay G, Paran Y, Bishara J, et al. Early impact of PCV7/PCV13 sequential introduction to the national pediatric immunization plan, on adult invasive pneumococcal disease: a nationwide surveillance study. Vaccine. 2015;33(9):1135–42.CrossRefPubMedGoogle Scholar
  40. 40.
    Guevara M, Ezpeleta C, Gil-Setas A, et al. Reduced incidence of invasive pneumococcal disease after introduction of the 13-valent conjugate vaccine in Navarre, Spain, 2001–2013. Vaccine. 2014;32(22):2553–62.CrossRefPubMedGoogle Scholar
  41. 41.
    Meichtry J, Born R, Küffer M, et al. Serotype epidemiology of invasive pneumococcal disease in Swiss adults: a nationwide population-based study. Vaccine. 2014;32(40):5185–91.CrossRefPubMedGoogle Scholar
  42. 42.
    Bogaert D, De Groot R, Hermans PW. Streptococcus pneumoniae colonisation: the key to pneumococcal disease. Lancet Infect Dis. 2004;4(3):144–54.CrossRefPubMedGoogle Scholar
  43. 43.
    Gounder PP, Bruce MG, Bruden DJT, et al. Effect of the 13-valent pneumococcal conjugate vaccine on nasopharyngeal colonization by Streptococcus pneumoniae—Alaska, 2008–2012. J Infect Dis. 2014;209(8):1251–8.CrossRefPubMedGoogle Scholar
  44. 44.
    van Hoek AJ, Sheppard CL, Andrews NJ, et al. Pneumococcal carriage in children and adults two years after introduction of the thirteen valent pneumococcal conjugate vaccine in England. Vaccine. 2014;32(34):4349–55.CrossRefPubMedGoogle Scholar
  45. 45.
    Schwarz TF, Pauksens K, Juergens C, et al. Safety of a 13-valent pneumococcal conjugate vaccine in elderly adults previously immunized with a 23-valent pneumococcal polysaccharide vaccine: an open-label trial. World J Vaccines. 2013;3(4):123–9.CrossRefGoogle Scholar
  46. 46.
    Jiang Y, Gauthier A, Annemans L, et al. A public health and budget impact analysis of vaccinating at-risk adults and the elderly against pneumococcal diseases in Germany. Expert Rev Pharmacoecon Outcomes Res. 2012;12(5):631–43.CrossRefPubMedGoogle Scholar
  47. 47.
    Kuhlmann A, Theidel U, Pletz MW, et al. Potential cost-effectiveness and benefit-cost ratios of adult pneumococcal vaccination in Germany. Health Econ Rev. 2012;2(1):4.PubMedCentralCrossRefPubMedGoogle Scholar
  48. 48.
    Liguori G, Parlato A, Zamparelli AS, et al. Adult immunization with 13-valent pneumococcal vaccine in Campania region, South Italy: an economic evaluation. Hum Vaccines Immunother. 2014;10(2):492–7.CrossRefGoogle Scholar
  49. 49.
    Pradas R, Gil de Miguel A, Alvaro A, et al. Budget impact analysis of a pneumococcal vaccination programme in the 65-year-old Spanish cohort using a dynamic model. BMC Infect Dis. 2013;13:175.PubMedCentralCrossRefPubMedGoogle Scholar
  50. 50.
    Rozenbaum MH, van Hoek AJ, Fleming D, et al. Vaccination of risk groups in England using the 13 valent pneumococcal conjugate vaccine: economic analysis. BMJ. 2012;345:e6879.PubMedCentralCrossRefPubMedGoogle Scholar
  51. 51.
    Rozenbaum MH, Hak E, van der Werf TS, et al. Results of a cohort model analysis of the cost-effectiveness of routine immunization with 13-valent pneumococcal conjugate vaccine of those aged ≥65 years in the Netherlands. Clin Ther. 2010;32(8):1517–32.CrossRefPubMedGoogle Scholar
  52. 52.
    Chen J, O’Brien MA, Yang HK, et al. Cost-effectiveness of pneumococcal vaccines for adults in the United States. Adv Ther. 2014;31(4):392–409.PubMedCentralCrossRefPubMedGoogle Scholar
  53. 53.
    Cho B-H, Stoecker C, Link-Gelles R, et al. Cost-effectiveness of administering 13-valent pneumococcal conjugate vaccine in addition to 23-valent pneumococcal polysaccharide vaccine to adults with immunocompromising conditions. Vaccine. 2013;31(50):6011–21.CrossRefPubMedGoogle Scholar
  54. 54.
    Smith KJ, Wateska AR, Nowalk M, et al. Cost-effectiveness of adult vaccination strategies using pneumococcal conjugate vaccine compared with pneumococcal polysaccharide vaccine. JAMA. 2012;307(8):804–12.PubMedCentralCrossRefPubMedGoogle Scholar
  55. 55.
    Smith KJ, Wateska AR, Nowalk MP, et al. Modeling of cost effectiveness of pneumococcal conjugate vaccination strategies in U.S. older adults. Am J Prev Med. 2013;44(4):373–81.PubMedCentralCrossRefPubMedGoogle Scholar
  56. 56.
    Smith KJ, Nowalk MP, Raymund M, et al. Cost-effectiveness of pneumococcal conjugate vaccination in immunocompromised adults. Vaccine. 2013;31(37):3950–6.PubMedCentralCrossRefPubMedGoogle Scholar
  57. 57.
    Weycker D, Sato R, Strutton D, et al. Public health and economic impact of 13-valent pneumococcal conjugate vaccine in US adults aged ≥50 years. Vaccine. 2012;30(36):5437–44.CrossRefPubMedGoogle Scholar
  58. 58.
    Tomczyk S, Bennett NM, Stoecker C, et al. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2014;63(37):822–5.PubMedGoogle Scholar
  59. 59.
    Sherwin RL, Gray S, Alexander R, et al. Distribution of 13-valent pneumococcal conjugate vaccine Streptococcus pneumoniae serotypes in US adults aged ≥50 years with community-acquired pneumonia. J Infect Dis. 2013;208(11):1813–20.CrossRefPubMedGoogle Scholar
  60. 60.
    Grijalva CG, Wunderink RG, Williams D, et al. Distribution of pneumococcal serotypes detected through urine analysis among US adults hospitalized with pneumonia after introduction of PCV13 [abstract no. ISPPD-0225]. Pneumonia. 2014;3:251.Google Scholar
  61. 61.
    Bewick T, Sheppard C, Greenwood S, et al. Serotype prevalence in adults hospitalised with pneumococcal non-invasive community-acquired pneumonia. Thorax. 2012;67(6):540–5.CrossRefPubMedGoogle Scholar
  62. 62.
    Payeras A, Villoslada A, Garau M, et al. Evolution of pneumococcal infections in adult patients during a four-year period after vaccination of a pediatric population with 13-valent pneumococcal conjugate vaccine. Int J Infect Dis. 2015;33:22–7.CrossRefPubMedGoogle Scholar
  63. 63.
    Castiglia P. Recommendations for pneumococcal immunization outside routine childhood immunization programs in Western Europe. Adv Ther. 2014;31(10):1011–44.PubMedCentralCrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2015

Authors and Affiliations

  1. 1.SpringerAucklandNew Zealand

Personalised recommendations