1236. Safety and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Healthy Infants in the United States

Abstract

Background A 20-valent pneumococcal conjugate vaccine (PCV20) is being developed to extend protection against pneumococcal disease beyond that of the 13-valent pneumococcal vaccine (PCV13). This is the first safety and immunogenicity study of PCV20 in healthy infants. Methods This randomized, double-blind study enrolled and randomized (1:1) healthy infants ≥ 42 to ≤ 98 days of age to receive a 4-dose series of either PCV20 or PCV13 (control) at 2, 4, 6, and 12 months of age. Local reactions and systemic events were assessed for 7 days after each vaccination; adverse events (AEs) and serious AEs (SAEs) were collected throughout the study. PCV20 immune responses (serotype-specific immunoglobulin G [IgG] and opsonophagocytic activity [OPA]) were measured in sera 1 month after the third infant dose and the fourth dose at 12 months of age. Results There were 460 subjects enrolled, with 416 and 391 subjects receiving 3 and 4 doses, respectively. Local reactions and systemic events were predominantly mild to moderate in severity and similar among vaccine groups. There were no related SAEs or deaths reported. PCV20 elicited IgG responses 1 month after the third dose with boosting after a fourth dose. OPA responses were also observed. Conclusion PCV20 was well tolerated with a safety profile similar to PCV13. PCV20 elicited immune responses to all 20 vaccine serotypes. Disclosures Shelly Senders, MD, Pfizer (Grant/Research Support) Nicola P. Klein, MD, PhD, GSK group of companies (Research Grant or Support)Merck (Grant/Research Support)Pfizer (Grant/Research Support)Protein Science (now SP) (Grant/Research Support)Sanofi Pasteur (Grant/Research Support) Erik Lamberth, MD, Pfizer (Employee) Allison Thompson, MD, Pfizer (Employee) Jelena Drozd, MS, Pfizer (Employee) James Trammel, MS, Pfizer (Employee) Yahong Peng, PhD, Pfizer (Employee, Shareholder) Peter Giardina, PhD, Pfizer (Employee) Kathrin U. Jansen, PhD, Pfizer (Employee, Shareholder) William C. Gruber, MD, Pfizer (Employee, Shareholder) Daniel Scott, MD, Pfizer (Employee, Shareholder) Wendy Watson, MD, Pfizer (Employee, Shareholder)

Phase 3 Safety and Immunogenicity Study of a Three-dose Series of Twenty-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

“…30 IgG GMCs were lower for some serotypes after 2 infant doses in this study compared with 3 infant doses; however, functional antibodies were induced after the infant series for all serotypes, and IgG GMCs were largely similar for both regimens after the toddler dose, supporting effectiveness of both schedules. 30 To reduce the likelihood of rejecting a potentially effective PCV in a 3-dose series, particularly a higher valent PCV, it is crucial to consider supportive immunogenicity data for serotypes missing statistical NI criteria, consistent with WHO guidance. This is important considering that the 7 additional PCV20 serotypes are associated with severe/invasive disease and antibiotic resistance 17–21 and are estimated to cause 21%–42% of IPD in young children in Europe.…”

“…11,12,22,23 PCV20 induced robust immune responses and demonstrated a safety/tolerability profile similar to PCV13 in several adult and pediatric clinical trials. 24–32 This study assessed safety and immunogenicity of a 3-dose PCV20 series compared with PCV13.…”

Immunogenicity and seroefficacy of pneumococcal conjugate vaccines – a systematic review and network meta-analysis

“…10,11,18-89 18 studies (20 publication records) were excluded from the analysis: 6 studies did not provide individual patient or aggregate data, [70][71][72][73] and 12 studies (14 publication records) were head-to-head studies with the vaccines of interest, but it was not possible to form a loop within the network meta-analysis to provide indirect evidence (See Supplementary Figure 1 and Supplementary Table 2). [74][75][76][77][78][79][80][81][82][83][84][85][86][87][88][89] Of these 12 studies, 8 reported results from different PCVs including a new Cuban PCV7, PCV10-SII, PCV11, PCV12, a Chinese PCV13, PCV14, PCV15, PCV20, PCV24 and PCV SP0202-VI. The remaining 27 studies (53 publication records) from 2009 to 2022 were included in the network meta-analyses.…”

Vaccines

“…A study out of Spain found that the safety profile and efficacy of PCV administration in low birth weight and preterm infants was similar to term infants ( López-Sanguos et al, 2019 ) [M]. A similar study was done with healthy infants given the PCV20, and similar adverse effects to the PCV13 were noted ( Senders et al, 2020 ) [MC].…”