The rationale for use of clinically defined outcomes in assessing the impact of pneumococcal conjugate vaccines against pneumonia

References

• Feikin DR, Scott JA, Gessner BD. Use of vaccines as probes to define disease burden. Lancet. 2014;383:1762–1770.
   PubMed Web of Science ®Google Scholar
• Gessner BD, Feikin DR. Vaccine preventable disease incidence as a complement to vaccine efficacy for setting vaccine policy. Vaccine. 2014;32:3133–3138.
   PubMed Web of Science ®Google Scholar
• Gessner BD, Sutanto A, Linehan M, et al. Incidences of vaccine-preventable Haemophilus influenzae type b pneumonia and meningitis in Indonesian children: hamlet-randomised vaccine-probe trial. Lancet. 2005;365:43–52.
   PubMed Web of Science ®Google Scholar
• Cutts FT, Zaman SM, Enwere G, et al. Efficacy of nine-valent pneumococcal conjugate vaccine against pneumonia and invasive pneumococcal disease in The Gambia: randomised, double-blind, placebo-controlled trial. Lancet. 2005;365:1139–1146.
   PubMed Web of Science ®Google Scholar
• Palmu AA, Jokinen J, Nieminen H, et al. Vaccine-preventable disease incidence of pneumococcal conjugate vaccine in the Finnish invasive pneumococcal disease vaccine trial. Vaccine. 2018;36:1816–1822.
   PubMed Web of Science ®Google Scholar
• Gessner BD, Jiang Q, Van Werkhoven CH, et al. A public health evaluation of 13-valent pneumococcal conjugate vaccine impact on adult disease outcomes from a randomized clinical trial in the Netherlands. Vaccine. 2019;37:5777–5787.
   PubMed Web of Science ®Google Scholar
• Leino T, Ollgren J, Salo H, et al. First year experience of rotavirus immunisation programme in Finland. Vaccine. 2021;31:176–182.
   Web of Science ®Google Scholar
• Panozzo CA, Becker-Dreps S, Pate V, et al. Direct, indirect, total, and overall effectiveness of the rotavirus vaccines for the prevention of gastroenteritis hospitalizations in privately insured US children, 2007-2010. Am J Epidemiol. 2014;179:895–909.
   PubMed Web of Science ®Google Scholar
• Nunes MC, Cutland CL, Jones S, et al. Efficacy of maternal influenza vaccination against all-cause lower respiratory tract infections in young infants: results from a randomized controlled trial. Clin Infect Dis. 2017;65:1066–1071.
   PubMed Web of Science ®Google Scholar
• RTS,S Clinical Trials Partnership. Efficacy and safety of RTS,S/AS01. malaria vaccine with or without a booster dose in infants and children in Africa: final results of a phase 3, individually randomised, controlled trial. Lancet. 2015;386:31–45.
   PubMed Web of Science ®Google Scholar
• Lucero MG, Dulalia VE, Nillos LT, et al. Pneumococcal conjugate vaccines for preventing vaccine-type invasive pneumococcal disease and x-ray defined pneumonia in children less than two years of age (review). Cochrane Database Syst Rev. 2009;4:CD004977.
   PubMed Web of Science ®Google Scholar
• Madhi SA, Kuwanda L, Cutland C, et al. The impact of a 9-valent pneumococcal conjugate vaccine on the public health burden of pneumonia in HIV-infected and -uninfected children. Clin Infect Dis. 2005;40:1511–1518.
   PubMed Web of Science ®Google Scholar
• Black SB, Shinefield HR, Ling S, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children younger than five years of age for prevention of pneumonia. Pediatr Infect Dis J. 2002;21:810–815.
   PubMed Web of Science ®Google Scholar
• US Centers for Disease Control and Prevention. Prevention of pneumococcal disease among infants and children – use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine: recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb Mort Wkly Rep. 2010;59(RR–11):1–15.
   PubMedGoogle Scholar
• Bonten MJ, Huijts SM, Bolkenbaas M, et al. Polysaccharide conjugate vaccine against pneumococcal pneumonia in adults. N Engl J Med. 2015;372:1114–1125.
   PubMed Web of Science ®Google Scholar
• 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. 2008;66:378–383.
   PubMed Web of Science ®Google Scholar
• McLaughlin JM, Jiang Q, Isturiz RE, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine against hospitalization for community-acquired pneumonia in older adults: a test-negative design. Clin Infect Dis. 2018;67:1498–1506.
   PubMed Web of Science ®Google Scholar
• van Werkhoven CH, Bolkenbaas M, Huijts SM, et al. Effects of 13-valent pneumococcal conjugate vaccination of adults on lower respiratory tract infections and antibiotic use in primary care: secondary analysis of a double-blind randomized placebo-controlled study. Clin Microbiol Infect. 2020.
   Web of Science ®Google Scholar
• Lessa F, Spiller M Effectiveness of PCV13 in adults hospitalized with pneumonia using Centers for Medicare & Medicaid Services data, 2014-2017. Presented to the Advisory Committee on Immunization Practices, February 27-28, 2019 and June 26-27, 2019. [cited 2020 Oct 13]. Available from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-02/Pneumococcal-3-Lessa-508.pdf/
   Google Scholar
• Lessa FC, Spiller M, Wu X, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine in US adults hospitalized with pneumonia, 2014-2017. Poster 2718, presented at ID Week, 2019, Washington DC.
   Google Scholar
• Kolditz M, Schmitt J, Pletz MW, et al. Impact of the 13-valent pneumococcal conjugate vaccine on incidence of all-cause pneumonia in adults aged ≥60 years – a population-based retrospective cohort study. Clin Infect Dis. 2019;68:2117–2119.
   PubMed Web of Science ®Google Scholar
• Isturiz RE, Ramirez J, Self WH, et al. Pneumococcal epidemiology among US adults hospitalized for community-acquired pneumonia. Vaccine. 2019;37:3352–3361.
   PubMed Web of Science ®Google Scholar
• Forstner C, Kolditz M, Kesselmeier M, et al. Pneumococcal conjugate serotype distribution and predominating role of serotype 3 in German adults with community-acquired pneumonia. Vaccine. 2020;38:1129–1136.
   PubMed Web of Science ®Google Scholar
• Pride MW, Huijts SM, Wu K, et al. Validation of an immunodiagnostic assay for detection of Streptococcus pneumoniae serotype-specific polysaccharides in human urine. Clin Vaccine Immunol. 2012;19:1131–1141.
   PubMed Web of Science ®Google Scholar
• Eletu SD, Sheppard CL, Thomas E, et al. Development of an extended-specificity multiplex immunoassay for detection of Streptococcus pneumoniae serotype-specific antigen in urine by use of human monoclonal antibodies. Clin Vaccine Immunol. 2017;24:e00262–17.
   PubMedGoogle Scholar
• Kalina WV, Souza V, Wu K, et al. Qualification and clinical validation of an immunodiagnostic assay for detecting 11 additional S. pneumoniae serotype-specific polysaccharides in human urine. Clin Infect Dis. 2020;71:e430–8.
   PubMed Web of Science ®Google Scholar
• 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:e60273.
   PubMed Web of Science ®Google Scholar
• Hagaman JT, Rouan GW, Shipley RT, et al. Admission chest radiograph lacks sensitivity in the diagnosis of community acquired pneumonia. Am J Med Sci. 2009;337:236–240.
   PubMed Web of Science ®Google Scholar
• Albaum MN, Hill LC, Murphy M, et al. Interobserver reliability of the chest radiograph in community-acquired pneumonia. PORT Investigators. Chest. 1996;110:343–350.
   PubMed Web of Science ®Google Scholar
• Ben-Shimol S, Dagan R, Givon-Lavi N, et al. Use of chest radiography examination as a probe for pneumococcal conjugate vaccine impact on lower respiratory tract infections in young children. Clin Infect Dis. 2020;71:177–187.
   PubMed Web of Science ®Google Scholar
• Saukkoriipi A, Palmu AA, Jokinen J, et al. Effect of antimicrobial use on pneumococcal diagnostic tests in elderly patients with community-acquired pneumonia. Eur J Clin Microbiol Infect Dis. 2015;34:697–704.
   PubMed Web of Science ®Google Scholar
• Froes F, Roche N, Blasi F. Pneumococcal vaccination and chronic respiratory diseases. Int J Chron Obstruct Pulmon Dis. 2017;12:3457–3468.
   PubMed Web of Science ®Google Scholar
• Madhi SA, Klugman KP. A role for Streptococcus pneumoniae in virus-associated pneumonia. Nat Med. 2004;10:811–813.
   PubMed Web of Science ®Google Scholar
• Karppinen S, Toivonen L, Schuez-Havupalo L, et al. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PhiD-CV10) against all respiratory tract infections in children under two years of age. Vaccine. 2019;37:2935–2941.
   PubMed Web of Science ®Google Scholar
• Huijts SM, Coenjaerts FEJ, Bolkenbaas M, et al. The impact of 13-valent pneumococcal conjugate vaccination on virus-associated community-acquired pneumonia in elderly: exploratory analysis of the CAPiTA trial. Clin Microbiol Infect. 2018;24:764–770.
   PubMed Web of Science ®Google Scholar
• Nunes M, Cutland C, Klugman KP, et al. Pneumococcal conjugate vaccine protection against coronaviruses-associated pneumonia hospitalization in children living with and without HIV. mBio. 2021;12:e02347–20.
   PubMed Web of Science ®Google Scholar
• Howard LM, Zhu Y, Griffin MR, et al. Nasopharyngeal pneumococcal density during asymptomatic respiratory virus infection and risk for subsequent acute respiratory illness. Emerg Infect Dis. 2019;25:2040–2047.
   PubMed Web of Science ®Google Scholar
• Carniel BF, Marcon F, Rylance J, et al. Pneumococcal colonization impairs nasal and lung mucosal immune responses to live attenuated influenza vaccination in adults. medRxiv 2020.
   Google Scholar
• Gessner BD, Jiang Q, van Werkhoven CH, et al. A post-hoc analysis of serotype-specific vaccine efficacy of 13-valent pneumococcal conjugate vaccine against clinical community acquired pneumonia from a randomized clinical trial in the Netherlands. Vaccine. 2019;37:4147–4154.
   PubMed Web of Science ®Google Scholar
• Matanock A Evidence to recommendations and GRADE for PCV13 use among immunocompetent adults ≥65 years old. Presented to the Advisory Committee on Immunization Practices, February 27-28, 2019 and June 26-27, 2019 [cited 2020 Oct 13]. Available from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-02/Pneumococcal-5-Matanock-508.pdf
   Google Scholar
• Djennad A, Ramsay ME, Pebody R, et al. Effectiveness of 23-valent polysaccharide pneumococcal vaccine and changes in invasive pneumococcal disease incidence from 2000 to 2017 in those aged 65 and over in England and Wales. E Clin Med. 2019;6:42–50.
   Google Scholar
• Hanquet G, Krizova P, Valentiner-Branth P, et al. Effect of childhood pneumococcal conjugate vaccination on invasive disease in older adults of 10 European countries: implications for adult vaccination. Thorax. 2019;74:473–482.
   PubMed Web of Science ®Google Scholar
• Regev-Yochay G, Chowers M, Chazan B, et al. Distribution of 13-valent pneumococcal conjugate vaccine serotype Streptococcus pneumoniae in adults 50 years and older presenting with community-acquired pneumonia in Israel. Hum Vaccines Immunother. 2018;14:2527–2532.
   PubMed Web of Science ®Google Scholar
• LeBlanc JJ, ElSherif M, Ye L, et al. Streptococcus pneumoniae serotype 3 is masking PCV13-mediated immunity in Canadian adults hospitalized with community acquired pneumonia: a study from the Serious Outcomes Surveillance (SOS) Network of the Canadian immunization research network (CIRN). Vaccine. 2019;37:5466–5473.
   PubMed Web of Science ®Google Scholar
• Theilacker C, Hansen KB, Runow E, et al. Pneumococcal serotype distribution in adults hospitalized with radiologically-confirmed community-acquired pneumonia in Malmö, Sweden [online ePoster/abstract 904]. ISPPD-12 2020 Digital Library. [cited 2020 Oct 13]. Available from: https://cslide.ctimeetingtech.com/isppd20/attendee/eposter/poster/904
   Google Scholar
• Pick H, Daniel P, Rodrigo C, et al. Pneumococcal serotype trends, surveillance and risk factors in UK adult pneumonia, 2013-18. Thorax. 2020;75:38–49.
   PubMed Web of Science ®Google Scholar
• Southern J, Andrews N, Sandu P, et al. Pneumococcal carriage in children and their household contacts six years after introduction of the 13-valent pneumococcal conjugate vaccine in England. PLoS One. 2018;13:e0195799.
   PubMed Web of Science ®Google Scholar
• Grant LR, Hammitt LL, O’Brien SE, et al. Impact of the 13-valent pneumococcal conjugate vaccine on pneumococcal carriage among American Indians. Pediatr Infect Dis J. 2016;35:907–914.
   PubMed Web of Science ®Google Scholar
• Dube FS, Ramjith J, Gardner-Lubbe S, et al. Streptococcus pneumoniae in a South African birth cohort post −13-valent pneumococcal conjugate vaccine implementation. Sci Rep. 2018;8:12497.
   PubMed Web of Science ®Google Scholar
• Chiavenna C, Presanis AM, Charlett A, et al. Estimating age-stratified influenza-associated invasive pneumococcal disease in England: a time-series model based on population surveillance data. PLoS Med. 2019;16:e1002829.
   PubMed Web of Science ®Google Scholar
• Arguedas A, Trzcinski K, O’Brien KL, et al. Upper respiratory tract colonization with Streptococcus pneumoniae in adults. Expert Rev Vaccines. 2020;19:353–366.
   PubMed Web of Science ®Google Scholar
• Smith EL, Wheeler I, Adler H, et al. Upper airways colonization of Streptococcus pneumoniae in adults aged 60 years and older: a systematic review of prevalence and individual participant data meta-analysis of risk factors. J Infect. 2020;81:540–548.
   PubMed Web of Science ®Google Scholar
• Leidner AJ Overview of three economic analyses of pneumococcal vaccinations at age 65. Presented to the Advisory Committee on Immunization Practices, February 27-28, 2019 and June 26-27, 2019 [cited 2020 Oct 13]. Available from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2019-02/Pneumococcal-4-Leidner-508.pdf
   Google Scholar
• Stoecker C, Kobayashi M, Matanock A, et al. Cost-effectiveness of continuing pneumococcal conjugate vaccination at age 65 in the context of indirect effects from the childhood immunization program. Vaccine. 2020;38:1770–1777.
   PubMed Web of Science ®Google Scholar
• Falkenhorst G, Remschmidt C, Harder T, et al. Background paper to the updated pneumococcal vaccination recommendation for older adults in Germany. Bundesgesundheitsblatt Gesundheitsforschung Gesunheitsschutz. 2016;59:1623–1657.
   PubMed Web of Science ®Google Scholar
• McLaughlin JM, Jiang Q, Gessner BD, et al. Pneumococcal conjugate vaccine against serotype 3 pneumococcal pneumonia in adults: a systematic review and pooled analysis. Vaccine. 2019;37:6310–6316.
   PubMed Web of Science ®Google Scholar
• Sings HL, De Wals P, Gessner BD, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine against invasive disease caused by serotype 3 in children: a systematic review and meta-analysis of observational studies. Clin Infect Dis. 2019;68:2135–2143.
   PubMed Web of Science ®Google Scholar
• Sings HL, Gessner BD, Wasserman M, et al. Pneumococcal conjugate vaccine impact on serotype 3: a review of surveillance data. Infect Dis Ther. 2021. In press.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. European public assessment report Prevenar 13, Appendix: summary of product characteristics. [cited 2020 Oct 13]. Available from: https://www.ema.europa.eu/en/documents/product-information/prevenar-13-epar-product-information_en.pdf
   Google Scholar
• European Medicines Agency. European public assessment report Synflorix, Appendix: summary of product characteristics. [cited 2020 Oct 13]. Available from: https://www.ema.europa.eu/en/documents/product-information/synflorix-epar-product-information_en.pdf
   Google Scholar
• Tregnaghi MW, Saez-Llorens X, Lopez P, et al. Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PhiD-CV) in young Latin American children: a double-blind randomized controlled trial. PloS Med. 2014;11:e1001657.
   PubMed Web of Science ®Google Scholar
• US Food and Drug Administration. Package insert Prevnar 13. [cited 2020 Oct 13]. Available from: https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert——Prevnar-13.pdf
   Google Scholar
• New Zealand Data Sheet for Prevenar 13. [cited 2020 Oct 13]. Available from: https://www.medsafe.govt.nz/profs/Datasheet/p/prevenar13inj.pdf
   Google Scholar
• Australian Product Information for Prevenar 13. [cited 2020 Oct 13]. Available from https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-07066-3&d=202012291016933
   Google Scholar
• Melegaro A, Edmunds WJ. Cost-effectiveness analysis of pneumococcal conjugate vaccination in England and Wales. Vaccine. 2004;22:4203–4214.
   PubMed Web of Science ®Google Scholar
• van Hoek AJ, Choi YH, Trotter C, et al. The cost-effectiveness of a 13-valent pneumococcal conjugate vaccination for infants in England. Vaccine. 2012;30:7205–7213.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Pneumococcal conjugate vaccines in infants and children under 5 years of age: WHO position paper – february 2019. Wkly Epidemiol Rep. 2019;94:85–104.
   Google Scholar
• Patterson S, Webber C, Patton M, et al. A post hoc assessment of duration of protection in CAPiTA (Community Acquired Pneumonia Immunization Trial in Adults). Trials Vaccine. 2016;5:92–96.
   Google Scholar
• Theilacker C, Vyse A, Jodar L, et al. Evaluations of the public health impact of adult vaccination with pneumococcal vaccines should include reductions in all-cause pneumonia. Clin Infect Dis. 2020;70:2456–2457.
   PubMed Web of Science ®Google Scholar
• van Werkhoven CH, Huijits SM, Paling FP, et al. The scrutiny of identifying community-acquired pneumonia episodes quantified bias in absolute effect estimation in a population-based pneumococcal vaccination trial. J Clin Epidemiol. 2016;69:185–192.
   PubMed Web of Science ®Google Scholar
• Kwong JC, Schwartz KL, Campitelli MA, et al. Acute myocardial infarction after laboratory-confirmed influenza infection. N Engl J Med. 2018;378:345–353.
   PubMed Web of Science ®Google Scholar
• Aliberti S, Ramirez JA. Cardiac diseases complicating community-acquired pneumonia. Curr Opin Infect Dis. 2014;27:295–301.
   PubMed Web of Science ®Google Scholar
• Bloom DE, Fan VY, Sevilla JP. The broad socioeconomic benefits of vaccination. Sci Transl Med. 2018;10: pii:eaaj2345.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Immunization today and in the next decade: developing together the vision and strategy for immunization 2021-2030. Draft zero. [cited 2020 Oct 13]. Available from: https://www.who.int/immunization/ia2030_Draft_Zero.pdf?ua=1
   Google Scholar