Predicting effectiveness of the V114 vaccine against invasive pneumococcal disease in children

References

• Tan TQ. Pediatric invasive pneumococcal disease in the United States in the era of pneumococcal conjugate vaccines. Clin Microbiol Rev. 2012 Jul;25(3):409–419.
   PubMed Web of Science ®Google Scholar
• O’Brien KL, Wolfson LJ, Watt JP, et al. Burden of disease caused by Streptococcus pneumoniae in children younger than 5 years: global estimates. Lancet. 2009 Sep 12;374(9693):893–902.
   PubMed Web of Science ®Google Scholar
• Scelfo C, Menzella F, Fontana M, et al. Pneumonia and invasive pneumococcal diseases: the role of pneumococcal conjugate vaccine in the era of multi-drug resistance. Vaccines (Basel). 2021 Apr 22;9(5). DOI:10.3390/vaccines9050420.
   PubMed Web of Science ®Google Scholar
• Pilishvili T, Lexau C, Farley MM, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010 Jan 1;201(1):32–41.
   PubMed Web of Science ®Google Scholar
• 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 Mar;15(3):301–309.
   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
• Yildirim I, Hanage WP, Lipsitch M, et al. Serotype specific invasive capacity and persistent reduction in invasive pneumococcal disease. Vaccine. 2010 Dec 16 29(2):283–288.
   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 Oct 29 36(45):6883–6891.
   PubMed Web of Science ®Google Scholar
• Platt HL, Greenberg D, Tapiero B, et al. A phase II trial of safety, tolerability and immunogenicity of V114, a 15-Valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in healthy infants. Pediatr Infect Dis J. 2020 Aug;39(8):763–770.
   PubMed Web of Science ®Google Scholar
• Meulen A S-T, Vesikari T, Malacaman EA, et al. Safety, tolerability and immunogenicity of 15-valent pneumococcal conjugate vaccine in toddlers previously vaccinated with 7-valent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2015 Feb;34(2):186–194.
   PubMed Web of Science ®Google Scholar
• Rid A, Saxena A, Baqui AH, et al. Placebo use in vaccine trials: recommendations of a WHO expert panel. Vaccine. 2014 Aug 20;32(37):4708–4712.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Recommendations for the production and control of pneumococcal conjugate vaccines. WHO Technical Report Series 9272005.
   Google Scholar
• Siber GR, Chang I, Baker S, et al. Estimating the protective concentration of anti-pneumococcal capsular polysaccharide antibodies. Vaccine. 2007 May 10;25(19):3816–3826.
   PubMed Web of Science ®Google Scholar
• Ryman J, Weaver J, Hu T, et al. Predicting vaccine effectiveness against invasive pneumococcal disease in children using immunogenicity data (in press). NPJ Vaccines. Accepted. 2022.
   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 Sep;14(9):839–846.
   PubMed Web of Science ®Google Scholar
• Block SL, Klein NP, Sarpong K, et al. Lot-to-lot consistency, safety, tolerability and immunogenicity of an investigational hexavalent vaccine in US infants. Pediatr Infect Dis J. 2017 Feb;36(2):202–208.
   PubMed Web of Science ®Google Scholar
• A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006). ClinicalTrials.gov ID: NCT01340937. [updated 2018 Nov 15; cited 2022 Feb 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT01340937
   Google Scholar
• A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008). ClinicalTrials.gov ID: NCT02987972. [updated 2019 Oct 23; cited February 8, 2022]. Available from: https://clinicaltrials.gov/ct2/show/NCT02987972
   Google Scholar
• A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION). ClinicalTrials.gov ID: NCT03620162. [updated 2021 Sept 28; updated 2022 Feb 8]. Available from: https://clinicaltrials.gov/ct2/show/NCT03620162
   Google Scholar
• Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-029) (PNEU-PED). ClinicalTrials.gov ID: NCT03893448. [updated 2021 Nov 10; updated Feb 8, 2022]. Available from: https://clinicaltrials.gov/ct2/show/NCT03893448
   Google Scholar
• De Serres G, Pilishvili T, Link-Gelles R, et al. Use of surveillance data to estimate the effectiveness of the 7-valent conjugate pneumococcal vaccine in children less than 5 years of age over a 9 year period. Vaccine. 2012 Jun 8 30(27):4067–4072.
   PubMed Web of Science ®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 May;4(5):399–406.
   PubMed Web of Science ®Google Scholar
• Marchese RD, Puchalski D, Miller P, et al. Optimization and validation of a multiplex, electrochemiluminescence-based detection assay for the quantitation of immunoglobulin G serotype-specific antipneumococcal antibodies in human serum. Clin vaccin immunol. 2009 Mar;16(3):387–396.
   PubMedGoogle Scholar
• Nolan KM, Zhang Y, Antonello JM, et al. Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA. Bioanalysis. 2020 Oct;12(19):1363–1375.
   PubMed Web of Science ®Google Scholar
• Malik T, Elbasha E, Sharomi O. A dynamic model for assessing the impact of universal pneumococcal vaccination. Poster presented at: 12th International Symposium on Pneumococci and Pneumococcal Diseases; Toronto, Ontario, Canada; 2022 Jun 19-23.
   Google Scholar
• Ryman J, Weaver J, Hu T, et al. Predicting vaccine effectiveness and real-world impact of a novel 15-valent pediatric pneumococcal conjugate vaccine (PCV15). Poster presented at: 12th International Symposium on Pneumococci and Pneumococcal Diseases; Toronto, Ontario, Canada; 2022 Jun 19-23.
   Google Scholar
• Ladhani SN, Collins S, Djennad A, et al. Rapid increase in non-vaccine serotypes causing invasive pneumococcal disease in England and Wales, 2000-17: a prospective national observational cohort study. Lancet Infect Dis. 2018 Apr;18(4):441–451.
   PubMed Web of Science ®Google Scholar
• Zintgraff J, Gagetti P, Napoli D, et al. Invasive Streptococcus pneumoniae isolates from pediatric population in argentina for the period 2006-2019. Temporal progression of serotypes distribution and antibiotic resistance. Vaccine. 2022 Jan 24;40(3):459–470.
   PubMed Web of Science ®Google Scholar
• de Miguel S, Domenech M, Gonzalez-Camacho F, et al. Nationwide trends of invasive pneumococcal disease in spain from 2009 through 2019 in children and adults during the pneumococcal conjugate vaccine era. Clin Infect Dis. 2021 Dec 6;73(11):e3778–e3787.
   PubMed Web of Science ®Google Scholar
• Nanduri SA, Petit S, Smelser C, et al. Epidemiology of invasive early-Onset and late-Onset group B streptococcal disease in the United States, 2006 to 2015: multistate laboratory and population-Based surveillance. JAMA Pediatr. 2019 Mar 1;173(3):224–233.
   PubMed Web of Science ®Google Scholar
• Varghese J, Chochua S, Tran T, et al. Multistate population and whole genome sequence-based strain surveillance of invasive pneumococci recovered in the USA during 2017. Clin Microbiol Infect. 2020 Apr;26(4):512 e1–512 e10.
   PubMed Web of Science ®Google Scholar
• De Miguel S, Latasa P, Yuste J, et al. Age-dependent serotype-associated case-fatality rate in invasive pneumococcal disease in the autonomous community of Madrid between 2007 and 2020. Microorganisms. 2021 Nov 3;9(11):2286.
   PubMed Web of Science ®Google Scholar
• Lapidot R, Shea KM, Yildirim I, et al. Characteristics of serotype 3 invasive pneumococcal disease before and after universal childhood immunization with PCV13 in Massachusetts. Pathogens. 2020 May 21;9(5):396.
   Web of Science ®Google Scholar
• Adebanjo TA, Pondo T, Yankey D, et al. Pneumococcal conjugate vaccine breakthrough infections: 2001-2016. Pediatrics. 2020 Mar;145(3). DOI:10.1542/peds.2019-0836.
   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
• Savulescu C, Krizova P, Valentiner-Branth P, et al. Effectiveness of 10 and 13-valent pneumococcal conjugate vaccines against invasive pneumococcal disease in European children: spIDnet observational multicentre study. Vaccine. 2022 Jun 23;40(29):3963–3974.
   PubMed Web of Science ®Google Scholar
• Rupp R, Hurley D, Grayson S, et al. A dose ranging study of 2 different formulations of 15-valent pneumococcal conjugate vaccine (PCV15) in healthy infants. Hum Vaccin Immunother. 2019;15(3):549–559.
   PubMed Web of Science ®Google Scholar
• Amin-Chowdhury Z, Groves N, Sheppard CL, et al. Invasive pneumococcal disease due to 22F and 33F in England: a tail of two serotypes. Vaccine. 2021 Apr 1;39(14):1997–2004.
   PubMed Web of Science ®Google Scholar
• Golden AR, Fear T, Baxter M, et al. Invasive pneumococcal disease caused by serotypes 22F and 33F in Canada: the SAVE study 2011-2018. Diagn Microbiol Infect Dis. 2021 Oct;101(2):115447.
   PubMed Web of Science ®Google Scholar
• Sempere J, de Miguel S, González-Camacho F, et al. Clinical relevance and molecular pathogenesis of the emerging serotypes 22F and 33F of Streptococcus pneumoniae in Spain. Front Microbiol. 2020;11:309.
   PubMed Web of Science ®Google Scholar
• Hu T, Weiss T, Owusu-Edusei K, et al. Health and economic burden associated with 15-valent pneumococcal conjugate vaccine serotypes in children in the United States. J Med Econ. 2020 Dec;23(12):1653–1660.
   PubMed Web of Science ®Google Scholar
• Hu T, Weiss T, Bencina G, et al. Health and economic burden of invasive pneumococcal disease associated with 15-valent pneumococcal conjugate vaccine serotypes in children across eight European countries. J Med Econ. 2021 Jan-Dec;24(1):1098–1107.
   PubMed Web of Science ®Google Scholar
• Wasserman MD, Perdrizet J, Grant L, et al. Clinical and economic burden of pneumococcal disease due to serotypes contained in current and investigational pneumococcal conjugate vaccines in children under five years of age. Infect Dis Ther. 2021 Dec;10(4):2701–2720.
   PubMed Web of Science ®Google Scholar