A systematic review of invasive pneumococcal disease vaccine failures and breakthrough with higher-valency pneumococcal conjugate vaccines in children

References

• World Health Organization. Pneumococcal conjugate vaccines in infants and children under 5 years of age: WHO position paper – february 2019. Wkly Epidemiol Rec. 2019;94(8):85–104.
   Google Scholar
• Cohen O, Knoll M, O’Brien K, et al. Pneumococcal conjugate vaccine (PCV) product assessment. [Cited 2021 Jan 19] Available from: https://www.jhsph.edu/ivac/wp-content/uploads/2018/05/pcv-product-assessment-april-25-2017.pdf.
   Google Scholar
• Poolman JT, Peeters CCAM, van Den Dobbelsteen GPJM. The history of pneumococcal conjugate vaccine development: dose selection. Expert Rev Vaccines. 2013;12(12):1379–1394.
   PubMed Web of Science ®Google Scholar
• Ganaie F, Saad JS, McGee L, et al. A new pneumococcal capsule type, 10D, is the 100th serotype and has a large cps fragment from an oral Streptococcus. mBio. 2020;11(3):e00937–20.
   PubMed Web of Science ®Google Scholar
• De Wals P, Lefebvre B, Markowski F, et al. Impact of 2+1 pneumococcal conjugate vaccine program in the province of Quebec, Canada. Vaccine. 2014;32(13):1501–1506.
   PubMed Web of Science ®Google Scholar
• Deceuninck G, De Serres G, Boulianne N, et al. Effectiveness of three pneumococcal conjugate vaccines to prevent invasive pneumococcal disease in Quebec, Canada. Vaccine. 2015;33(23):2684–2689.
   PubMed Web of Science ®Google Scholar
• Domingues CMAS, Verani JR, Montenegro Renoiner EI, et al. Effectiveness of ten-valent pneumococcal conjugate vaccine against invasive pneumococcal disease in Brazil: a matched case-control study. Lancet Respir Med. 2014;2(6):464–471.
   PubMed Web of Science ®Google Scholar
• Jokinen J, Rinta-Kokko H, Siira L, et al. Impact of ten-valent pneumococcal conjugate vaccination on invasive pneumococcal disease in Finnish children–a population-based study. PLoS One. 2015;10(3):e0120290.
   PubMed Web of Science ®Google Scholar
• Verani JR, Domingues CMAS, de Moraes JC. Indirect cohort analysis of 10-valent pneumococcal conjugate vaccine effectiveness against vaccine-type and vaccine-related invasive pneumococcal disease. Vaccine. 2015;33(46):6145–6148.
   PubMed Web of Science ®Google Scholar
• Prymula R, Schuerman L. 10-valent pneumococcal nontypeable Haemophilus influenzae PD conjugate vaccine: synflorix. Expert Rev Vaccines. 2009;8(11):1479–1500.
   PubMed Web of Science ®Google Scholar
• Cohen O, Knoll M, O’Brien K, et al. Pneumococcal conjugate vaccine (PCV) review of impact evidence (PRIME): summary of findings from systematic review, October 2017. [ Cited 2021 19 January] Available from: https://www.who.int/immunization/sage/meetings/2017/october/3_FULL_PRIME_REPORT_2017Sep26.pdf?ua=1.
   Google Scholar
• Cohen R, Cohen JF, Chalumeau M, et al. Impact of pneumococcal conjugate vaccines for children in high- and non-high-income countries. Expert Rev Vaccines. 2017;16(6):625–640.
   PubMed Web of Science ®Google Scholar
• de Oliveira LH, Camacho LAB, Coutinho ESF, et al., Impact and effectiveness of 10 and 13-valent pneumococcal conjugate vaccines on hospitalization and mortality in children aged less than 5 years in Latin American countries: a systematic review. PLoS One. 2016;11(12):e0166736.
   PubMed Web of Science ®Google Scholar
• Mrkvan T, Pelton SI, Ruiz-Guinazu J, et al. Effectiveness and impact of the 10-valent pneumococcal conjugate vaccine, PHiD-CV: review of clinical trials and post-marketing experience. Expert Rev Vaccines. 2018;17(9):797–818.
   PubMed Web of Science ®Google Scholar
• Ngocho JS, Magoma B, Olomi GA, et al. Effectiveness of pneumococcal conjugate vaccines against invasive pneumococcal disease among children under five years of age in Africa: a systematic review. PLoS One. 2019;14(2):e0212295.
   PubMed Web of Science ®Google Scholar
• Naucler P, Galanis I, Morfeldt E, et al., Comparison of the impact of pneumococcal conjugate vaccine 10 or pneumococcal conjugate vaccine 13 on invasive pneumococcal disease in equivalent populations. Clin Infect Dis. 2017;65(11):1780–1789.
   PubMed Web of Science ®Google Scholar
• Balsells E, Guillot L, Nair H, et al. Serotype distribution of Streptococcus pneumoniae causing invasive disease in children in the post-PCV era: a systematic review and meta-analysis. PLoS One. 2017;12(5):e0177113.
   PubMed Web of Science ®Google Scholar
• Izurieta P, Bahety P, Adegbola R, et al. Public health impact of pneumococcal conjugate vaccine infant immunization programs: assessment of invasive pneumococcal disease burden and serotype distribution. Expert Rev Vaccines. 2018;17(6):479–493.
   PubMed Web of Science ®Google Scholar
• Oligbu G, Hsia Y, Folgori L, et al., Pneumococcal conjugate vaccine failure in children: a systematic review of the literature. Vaccine. 2016;34(50):6126–6132.
   PubMed Web of Science ®Google Scholar
• Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.
   PubMed Web of Science ®Google Scholar
• Sterne JA, Hernan MA, Reeves BC, et al. ROBINS-I: a tool for assessing risk of bias in non-randomised studies of interventions. BMJ. 2016;355:i4919.
   PubMed Web of Science ®Google Scholar
• Grant LR, O’Brien SE, Burbidge P, et al. Comparative immunogenicity of 7 and 13-valent pneumococcal conjugate vaccines and the development of functional antibodies to cross-reactive serotypes. PLoS One. 2013;8(9):e74906.
   PubMed Web of Science ®Google Scholar
• Agier MS, Marchand S, Paret N, et al. [Post-licensure safety surveillance for Prevenar 13((R)) in France]. Arch Pediatr. 2017;24(5):439–444.
   PubMed Web of Science ®Google Scholar
• Almeida AF, Sobrinho-Simoes J, Ferraz C, et al. Pneumococcal pneumonia vaccine breakthroughs and failures after 13-valent pneumococcal conjugated vaccine. Eur J Public Health. 2016;26(5):887–889.
   PubMed Web of Science ®Google Scholar
• Andrews N, Kent A, Amin-Chowdhury Z, et al. Effectiveness of the seven-valent and thirteen-valent pneumococcal conjugate vaccines in England: the indirect cohort design, 2006–2018. Vaccine. 2019;37(32):4491–4498.
   PubMed Web of Science ®Google Scholar
• Antachopoulos C, Tsolia MN, Tzanakaki G, et al. Parapneumonic pleural effusions caused by Streptococcus pneumoniae serotype 3 in children immunized with 13-valent conjugated pneumococcal vaccine. Pediatr Infect Dis J. 2014;33(1):81–83.
   PubMed Web of Science ®Google Scholar
• Asner SA, Agyeman PKA, Gradoux E, et al. Burden of Streptococcus pneumoniae sepsis in children after introduction of pneumococcal conjugate vaccines: a prospective population-based cohort study. Clin Infect Dis. 2019;69(9):1574–1580.
   PubMed Web of Science ®Google Scholar
• Blyth CC, Jayasinghe S, Andrews RM. A rationale for change: an increase in Invasive Pneumococcal Disease in fully vaccinated children. Clin Infect Dis. 2020;70(4):680–683.
   PubMed Web of Science ®Google Scholar
• Cohen C, Von Mollendorf C, de Gouveia L, et al. Effectiveness of the 13-valent pneumococcal conjugate vaccine against invasive pneumococcal disease in South African children: a case-control study. Lancet Glob Health. 2017;5(3):e359–e369.
   PubMed Web of Science ®Google Scholar
• De Wals P, Lefebvre B, Deceuninck G, et al., Incidence of invasive pneumococcal disease before and during an era of use of three different pneumococcal conjugate vaccines in Quebec. Vaccine. 2018;36(3):421–426.
   PubMed Web of Science ®Google Scholar
• Diawara I, Zerouali K, Katfy K, et al. Invasive pneumococcal disease among children younger than 5 years of age before and after introduction of pneumococcal conjugate vaccine in Casablanca, Morocco. Int J Infect Dis. 2015;40:95–101.
   PubMed Web of Science ®Google Scholar
• Dominguez A, Ciruela P, Hernandez S, et al. Effectiveness of the 13-valent pneumococcal conjugate vaccine in preventing invasive pneumococcal disease in children aged 7–59 months. A matched case-control study. PLoS One. 2017;12(8):e0183191.
   PubMed Web of Science ®Google Scholar
• Godot C, Levy C, Varon E, et al. Pneumococcal meningitis vaccine breakthroughs and failures after routine 7-valent and 13-valent pneumococcal conjugate vaccination in children in France. Pediatr Infect Dis J. 2015;34(10):e260–263.
   PubMed Web of Science ®Google Scholar
• Guevara M, Barricarte A, Torroba L, et al. Direct, indirect and total effects of 13-valent pneumococcal conjugate vaccination on invasive pneumococcal disease in children in Navarra, Spain, 2001 to 2014: cohort and case-control study. Euro Surveill. 2016;21(14):30186.
   Google Scholar
• 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):1066–1073.
   PubMed Web of Science ®Google Scholar
• Jayasinghe S, Chiu C, Quinn H, et al. Effectiveness of 7- and 13-valent pneumococcal conjugate vaccines in a schedule without a booster dose: a 10-year observational study. Clin Infect Dis. 2018;67(3):367–374.
   PubMed Web of Science ®Google Scholar
• Latasa P, Ordobas M, Garrido-Estepa M, et al. Effectiveness of different vaccine schedules for heptavalent and 13-valent conjugate vaccines against pneumococcal disease in the Community of Madrid. Vaccine. 2017;35(40):5381–5387.
   PubMed Web of Science ®Google Scholar
• Mackenzie GA, Hill PC, Jeffries DJ, et al. Effect of the introduction of pneumococcal conjugate vaccination on invasive pneumococcal disease in The Gambia: a population-based surveillance study. Lancet Infect Dis. 2016;16(6):703–711.
   PubMed Web of Science ®Google Scholar
• Madhi F, Godot C, Bidet P, et al. Serotype 3 pneumococcal pleural empyema in an immunocompetent child after 13-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014;33(5):545–546.
   PubMed Web of Science ®Google Scholar
• Mereckiene J, Fitzgerald M, Cotter S, et al. Invasive pneumococcal disease (IPD) and effect of pneumococcal conjugate vaccines in Ireland in 2008–2013. European Scientific Conference on Applied Infectious Disease Epidemiology; 2014;Stockholm, Sweden.
   Google Scholar
• Moore MR, Link-Gelles R, Schaffner W, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine for prevention of invasive pneumococcal disease in children in the USA: a matched case-control study. Lancet Respir Med. 2016;4(5):399–406.
   PubMed Web of Science ®Google Scholar
• Novak D, Lundgren A, Westphal S, et al. Two cases of hemolytic uremic syndrome caused by Streptococcus pneumoniae serotype 3, one being a vaccine failure. Scand J Infect Dis. 2013;45(5):411–414.
   PubMed Web of Science ®Google Scholar
• Okonji Z, Kozakova J. Molecular characterization of Streptococcus pneumoniae isolates recovered from cases of pneumococcal vaccine failure in children under five years of age in the Czech Republic in 2012–2014. Epidemiol Mikrobiol Imunol. 2018;67(3):99–103.
   PubMed Web of Science ®Google Scholar
• Ong R, Tan N, Chong C, et al. Pediatric invasive pneumococcal disease associated with pneumococcal conjugate vaccine failures in Singapore: a case series. 33rd Annual Meeting of the European Society for Paediatric Infectious Diseases; 2015;Leipzig, Germany.
   Google Scholar
• Sutcu M, Akturk H, Karagozlu F, et al. Empyema due to Streptococcus pneumoniae serotype 9V in a child immunized with 13-valent conjugated pneumococcal vaccine. Balkan Med J. 2017;34(1):74–77.
   PubMed Web of Science ®Google Scholar
• van der Linden M, Falkenhorst G, Perniciaro S, et al. Effectiveness of pneumococcal conjugate vaccines (PCV7 and PCV13) against invasive pneumococcal disease among children under two years of age in Germany. PLoS One. 2016;11(8):e0161257.
   PubMed Web of Science ®Google Scholar
• Corcoran M, Mereckiene J, Cotter S, et al. Invasive Streptococcus pneumoniae infections and vaccine failures in children in Ireland from the postvaccine era from 2007 to 2018. Pediatr Infect Dis J. 2020;39(4):339–344.
   PubMed Web of Science ®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(6):e1001657.
   PubMed Web of Science ®Google Scholar
• Palmu AA, Jokinen J, Borys D, et al. Effectiveness of the ten-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against invasive pneumococcal disease: a cluster randomised trial. Lancet. 2013;381(9862):214–222.
   PubMed Web of Science ®Google Scholar
• Hausdorff WP, Bryant J, Paradiso PR, et al. Which pneumococcal serogroups cause the most invasive disease: implications for conjugate vaccine formulation and use, part I. Clin Infect Dis. 2000;30(1):100–121.
   PubMed Web of Science ®Google Scholar
• 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. 2010;7(10):e1000348.
   PubMed Web of Science ®Google Scholar
• Oligbu G, Collins S, Andrews N, et al. Characteristics and serotype distribution of childhood cases of invasive pneumococcal disease following pneumococcal conjugate vaccination in England and Wales, 2006–2014. Clin Infect Dis. 2017;65(7):1191–1198.
   PubMed Web of Science ®Google Scholar
• Australian Government Department of Health. Australian Technical Advisory Group on Immunisation. Public consultation on the infant pneumococcal vaccination schedule. [cited 2021 Mar 9]. Available from: https://consultations.health.gov.au/ohp-immunisation-branch/infant-pneumococcal-vaccination-schedule-recommend/supporting_documents/Public%20Consultation%20Document%20%20Infant%20Pneumococcal%20Vaccination%20Schedule%20Recommendations.pdf.
   Google Scholar
• Conklin L, Loo JD, Kirk J, et al. Systematic review of the effect of pneumococcal conjugate vaccine dosing schedules on vaccine-type invasive pneumococcal disease among young children. Pediatr Infect Dis J. 2014;33(Suppl 2):S109–118.
   PubMed Web of Science ®Google Scholar
• Adebanjo TA, Pondo T, Yankey D, et al. Pneumococcal Conjugate Vaccine Breakthrough Infections: 2001–2016. Pediatrics. 2020;145(3):e20190836.
   Web of Science ®Google Scholar
• Hernández S, Moraga-Llop F, Díaz A, et al. Failures of 13-Valent Conjugated Pneumococcal Vaccine in Age-Appropriately Vaccinated Children 2–59 Months of Age, Spain. Emerg Infect Dis. 2020;26(6):1147–1155.
   PubMed Web of Science ®Google Scholar
• Andrews NJ, Waight PA, Burbidge P, et al. Serotype-specific effectiveness and correlates of protection for the 13-valent pneumococcal conjugate vaccine: a postlicensure indirect cohort study. Lancet Infect Dis. 2014;14(9):839–846.
   PubMed Web of Science ®Google Scholar
• Weinberger R, van der Linden M, Imohl M, et al. Vaccine effectiveness of PCV13 in a 3+1 vaccination schedule. Vaccine. 2016;34(18):2062–2065.
   PubMed Web of Science ®Google Scholar
• Linley E, Bell A, Gritzfeld JF, et al. Should pneumococcal serotype 3 be included in serotype-specific immunoassays? Vaccines (Basel). 2019;7(1):4.
   Web of Science ®Google Scholar
• Poolman J, Borrow R. Hyporesponsiveness and its clinical implications after vaccination with polysaccharide or glycoconjugate vaccines. Expert Rev Vaccines. 2011;10(3):307–322.
   PubMed Web of Science ®Google Scholar
• Joint Committee on Vaccination and Immunization (JCVI). Minute of the meeting on 04 October 2017. [Cited 2021 Jan 26] Available from: https://app.box.com/s/iddfb4ppwkmtjusir2tc/file/247634612957.
   Google Scholar
• Public Health England. Pneumococcal vaccination: infant schedule changes from January 2020 letter. [ Cited 2021 26 January] Available from: https://www.gov.uk/government/publications/pneumococcal-vaccination-infant-schedule-changes-from-january-2020-letterr.
   Google Scholar
• Thompson A, Lamberth E, Severs J, et al. Phase 1 trial of a 20-valent pneumococcal conjugate vaccine in healthy adults. Vaccine. 2019;37(42):6201–6207.
   PubMed Web of Science ®Google Scholar
• Greenberg D, Hoover PA, Vesikari T, et al. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Vaccine. 2018;36(45):6883–6891.
   PubMed Web of Science ®Google Scholar
• Feikin DR, Kagucia EW, Loo JD, et al. Serotype-specific changes in invasive pneumococcal disease after pneumococcal conjugate vaccine introduction: a pooled analysis of multiple surveillance sites. PLoS Med. 2013;10(9):e1001517.
   PubMed Web of Science ®Google Scholar
• Hicks LA, Harrison LH, 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. 2007;196(9):1346–1354.
   PubMed Web of Science ®Google Scholar
• 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. 2010;14(3):e197–209.
   PubMed Web of Science ®Google Scholar
• Dagan R, Poolman J, Siegrist CA. Glycoconjugate vaccines and immune interference: a review. Vaccine. 2010;28(34):5513–5523.
   PubMed Web of Science ®Google Scholar
• Weinberger DM, Malley R, Lipsitch M. Serotype replacement in disease after pneumococcal vaccination. Lancet. 2011;378(9807):1962–1973.
   PubMed Web of Science ®Google Scholar
• Scott NR, Mann B, Tuomanen EI, et al. Multi-Valent Protein Hybrid Pneumococcal Vaccines: a Strategy for the Next Generation of Vaccines. Vaccines (Basel). 2021;9(3):209.
   Web of Science ®Google Scholar