Immunogenicity of a 20-valent pneumococcal conjugate vaccine in adults 18 to 64 years old with medical conditions and other factors that increase risk of pneumococcal disease

Charu Sabharwal, Vani Sundaraiyer, Yahong Peng, Lisa Moyer, Todd J Belanger, Bradford D Gessner, Luis Jodar, Kathrin U Jansen, William C Gruber, Daniel A Scott, Wendy Watson, Charu Sabharwal, Vani Sundaraiyer, Yahong Peng, Lisa Moyer, Todd J Belanger, Bradford D Gessner, Luis Jodar, Kathrin U Jansen, William C Gruber, Daniel A Scott, Wendy Watson

Abstract

NCT03760146, NCT03828617.

Keywords: 20-valent; Clinical trial; Streptococcus pneumoniae; at-risk; immunogenicity; invasive pneumococcal disease; pneumococcal conjugate vaccine.

Conflict of interest statement

CS, YP, LM, TB, KUJ, WCG, DAS, BG, LJ, and WW are employees of Pfizer and may hold stock and/or stock options. VS reports no conflict of interest.

Figures

Figure 1.
Figure 1.
Pneumococcal OPA GMTs with 2-sided 95% CIs for the PCV20 serotypes before vaccination and 1 month after PCV20 in participants with ≥1 risk factor*: evaluable immunogenicity population.
Figure 2.
Figure 2.
Pneumococcal OPA GMRs (PCV20/PCV13) with 2-sided 95% CIs for the PCV13 serotypes 1 month after vaccination in participants with ≥1 risk factor*: evaluable immunogenicity population.
Figure 3.
Figure 3.
Pneumococcal OPA GMRs (PCV20/PPSV23) with 2-sided 95% CIs for the 7 additional serotypes 1 month  after vaccination in participants 60–64 years old* with ≥1 risk factor†: evaluable immunogenicity population.
Figure 4.
Figure 4.
Percentage (with 95% CIs) of participants with a ≥4-fold rise in OPA titers from before to 1 month after PCV13 or PCV20 for the PCV20 serotypes in participants with ≥1 risk factor*: evaluable immunogenicity population.

References

    1. World Health Organization . Pneumococcal vaccines WHO position paper—2012. Wkly Epidemiol Rec. 2012;87(14):1–7.
    1. Blasi F, Mantero M, Santus P, Tarsia P.. Understanding the burden of pneumococcal disease in adults. Clin Microbiol Infect. 2012;18(suppl 5):7–14. doi:10.1111/j.1469-0691.2012.03937.x.
    1. Vadlamudi NK, Chen A, Marra F. Impact of 13-valent pneumococcal conjugate vaccine among adults: a systematic review and meta-analysis. Clin Infect Dis. 2018;69(1):34–49. doi:10.1093/cid/ciy872.
    1. Perdrizet J, Wasserman M, Farkouh RA, Chilson E. Estimated pneumococcal disease and economic burden for current and future vaccine serotypes in United States in children under five years of age. Paper presented at: International Symposium on Pneumococci and Pneumococcal Diseases; 2020 Jun 19–23; Toronto, Canada. Digital Library. .
    1. van der Linden M, Imohl M, Perniciaro S. Limited indirect effects of an infant pneumococcal vaccination program in an aging population. PLoS One. 2019;14(8):e0220453. doi:10.1371/journal.pone.0220453.
    1. de Miguel S, Domenech M, Gonzalez-Camacho F, Sempere J, Vicioso D, Sanz JC, Garcia Comas L, Ardanuy C, Fenoll A, Yuste J. Nationwide trends of invasive pneumococcal disease in Spain (2009-2019) in children and adults during the pneumococcal conjugate vaccine era. Clin Infect Dis. 2020;73(11): e3778–e3787. doi:10.1093/cid/ciaa1483.
    1. Moore MR, Link-Gelles R, Schaffner W, Lynfield R, Lexau C, Bennett NM, Petit S, Zansky SM, Harrison LH, Reingold A, et al. Impact of 13-valent pneumococcal conjugate vaccine used in children on invasive pneumococcal disease in children and adults in the United States: analysis of multisite, population-based surveillance. Lancet Infect Dis. 2015;15(3):301–09. doi:10.1016/S1473-3099(14)71081-3.
    1. Hausdorff WP, Hanage WP. Interim results of an ecological experiment - conjugate vaccination against the pneumococcus and serotype replacement. Hum Vaccin Immunother. 2016;12(2):358–74. doi:10.1080/21645515.2015.1118593.
    1. Metcalf BJ, Gertz RE Jr., Gladstone RA, Walker H, Sherwood LK, Jackson D, Li Z, Law C, Hawkins PA, Chochua S, et al. Strain features and distributions in pneumococci from children with invasive disease before and after 13-valent conjugate vaccine implementation in the USA. Clin Microbiol Infect. 2016;22(1):60.e69–60.e29. doi: 10.1016/j.cmi.2015.08.027.
    1. Tomczyk S, Lynfield R, Schaffner W, Reingold A, Miller L, Petit S, Holtzman C, Zansky SM, Thomas A, Baumbach J, et al. Prevention of antibiotic-nonsusceptible invasive pneumococcal disease with the 13-valent pneumococcal conjugate vaccine. Clin Infect Dis. 2016;62(9):1119–25. doi:10.1093/cid/ciw067.
    1. Food and Drug Administration . BLA approval and BLA accelerated approval letter. [accessed 2021 June 18]. .
    1. Essink B, Sabharwal C, Cannon K, Frenck R, Lal H, Xu X, Sundaraiyer V, Peng Y, Moyer L, Pride M, et al. Pivotal phase 3 randomized clinical trial of the safety, tolerability, and immunogenicity of 20-valent pneumococcal conjugate vaccine in adults 18 years and older. Clin Infect Dis. 2022;75(3):390–98. doi:10.1093/cid/ciab990.
    1. Klein NP, Peyrani P, Yacisin K, Caldwell N, Xu X, Scully IL, Scott DA, Jansen KU, Gruber WC, Watson W. A phase 3, randomized, double-blind study to evaluate the immunogenicity and safety of 3 lots of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults 18 through 49 years of age. Vaccine. 2021;39(38):5428–35. doi:10.1016/j.vaccine.2021.07.004.
    1. Grant LR, Slack MPE, Yan Q, Trzcinski K, Barratt J, Sobczyk E, Appleby J, Cane A, Jodar L, Isturiz RE, et al. The epidemiologic and biologic basis for classifying older age as a high-risk, immunocompromising condition for pneumococcal vaccine policy. Expert Rev Vaccines. 2021;20(6):691–705. doi:10.1080/14760584.2021.1921579.
    1. Baxter R, Yee A, Aukes L, Snow V, Fireman B, Atkinson B, Klein NP. Risk of underlying chronic medical conditions for invasive pneumococcal disease in adults. Vaccine. 2016;34(36):4293–97. doi:10.1016/j.vaccine.2016.07.003.
    1. Weycker D, Farkouh RA, Strutton DR, Edelsberg J, Shea KM, Pelton SI. Rates and costs of invasive pneumococcal disease and pneumonia in persons with underlying medical conditions. BMC Health Serv Res. 2016;16(1):182. doi:10.1186/s12913-016-1432-4.
    1. Sabharwal C, Suaya J, Sundaraiyer V, Peng Y, Moyer L. Immunogenicity of a 20-valent pneumococcal conjugate vaccine across age groups in adults 18 years and older. Paper presented at: European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2021; 2021. Jul 9–12; Virtual congress (online).
    1. Kobayashi M, Farrar JL, Gierke R, Britton A, Childs L, Leidner AJ, Campos-Outcalt D, Morgan RL, Long SS, Talbot HK, et al. Use of 15-valent pneumococcal conjugate vaccine and 20-valent pneumococcal conjugate vaccine among U.S. adults: updated recommendations of the Advisory Committee on Immunization Practices - United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(4):109–17. doi:10.15585/mmwr.mm7104a1.
    1. PREVNAR 20- pneumococcal 20-valent conjugate vaccine injection, suspension Wyeth pharmaceutical division of Wyeth Holdings LLC. ; 2021.
    1. Zimmermann P, Curtis N. Factors that influence the immune response to vaccination. Clin Microbiol Rev. 2019;32(2):e00084–00018. doi:10.1128/cmr.00084-18.
    1. Torres A, Blasi F, Dartois N, Akova M. Which individuals are at increased risk of pneumococcal disease and why? Impact of COPD, asthma, smoking, diabetes, and/or chronic heart disease on community-acquired pneumonia and invasive pneumococcal disease. Thorax. 2015;70(10):984–89. doi:10.1136/thoraxjnl-2015-206780.
    1. Arcavi L, Benowitz NL. Cigarette smoking and infection. Arch Intern Med. 2004;164(20):2206–16. doi:10.1001/archinte.164.20.2206.
    1. Fukuda H, Onizuka H, Nishimura N, Kiyohara K. Risk factors for pneumococcal disease in persons with chronic medical conditions: results from the LIFE study. Int J Infect Dis. 2022;116:216–22. doi:10.1016/j.ijid.2021.12.365.
    1. Suaya JA, Jiang Q, Scott DA, Gruber WC, Webber C, Schmoele-Thoma B, Hall-Murray CK, Jodar L, Isturiz RE. Post hoc analysis of the efficacy of the 13-valent pneumococcal conjugate vaccine against vaccine-type community-acquired pneumonia in at-risk older adults. Vaccine. 2018;36(11):1477–83. doi:10.1016/j.vaccine.2018.01.049.
    1. McLaughlin JM, Jiang Q, Isturiz RE, Sings HL, Swerdlow DL, Gessner BD, Carrico RM, Peyrani P, Wiemken TL, Mattingly WA, et al. Effectiveness of 13-valent pneumococcal conjugate vaccine against hospitalization for community-acquired pneumonia in older US adults: a test-negative design. Clin Infect Dis. 2018;67(10):1498–506. doi:10.1093/cid/ciy312.
    1. Lewnard JA, Bruxvoort KJ, Fischer H, Hong VX, Grant LR, Jodar L, Cane A, Gessner BD, Tartof SY. Effectiveness of 13-valent pneumococcal conjugate vaccine against medically-attended lower respiratory tract infection and pneumonia among older adults. Clin Infect Dis. 2022;75(5): 832–41. doi:10.1093/cid/ciab1051.

Source: PubMed

3
Abonner