Pneumococcal Vaccination in a High-Risk Adult: A Patient Case
Streptococcus pneumoniae is associated with significant global burden of disease and is a lead cause of hospitalization in the incidence of invasive pneumococcal disease (IPD).1 Chronic conditions such as heart, liver, lung disease as well as certain behavioural factors such as smoking and tobacco use increase the risk of PD.1 The 15-valent pneumococcal conjugate vaccine provides serotype coverage against the 15 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F) which have emerged as a leading cause of IPD.1,2 The vaccine has shown robust immune response and tolerance among patients including those at-risk for IPD.1,2
“Read this hypothetical case showing how the 15-valent pneumococcal conjugate vaccine elicits immune response in immunocompetent adults at-risk for IPD “
Study details:
Study methodology:
PNEU DAY was a phase 3, multicentre, randomized, double-blind comparator-controlled study conducted at 79 sites worldwide.1
Patient population: A total of 1515 participants were randomised, wherein n=1135 received the 15-valent pneumococcal conjugate vaccine (PCV15) and n=380 received comparator, the 13-valent pneumococcal conjugate vaccine (PCV13).1
Inclusion criteria: Immunocompetent adults aged 18–49 years with or without risk factors for pneumococcal disease (PD) were eligible for the study if they were verified as pneumococcal vaccine naive by medical history and record review.1
Study treatment:
Participants in the phase 3 trial were randomised 3:1 ratio to receive a single dose of 15 valent pneumococcal conjugate vaccine (PCV15) or comparator on Day 1, followed by a single dose of 23-valent pneumococcal polysaccharide vaccine (PPSV23) at Month 6.1
Study duration:
The study was conducted from July 2018 through July 2020.1
Primary endpoints:
Included serotype-specific OPA geometric mean titers (GMTs) for the 15 serotypes included in 15-valent pneumococcal conjugate vaccine at Day 30 within each vaccination group separately.1
Secondary endpoints:
Included observed serotype-specific IgG geometric mean concentrations (GMCs) at Day 30, OPA GMTs and IgG GMCs at Month 6 and Month 7, as well as geometric mean fold rises (GMFRs) and proportions of participants with a ≥4-fold rise in OPA and IgG responses immediately prior to, and following, vaccination within each vaccination group separately.1
The Advisory Committee on Immunization Practices (ACIP) recommends a single dose of the 15- valent pneumococcal conjugate vaccine PCV15 followed at a ≥1 year interval with a single dose of PPSV23, for adults aged 19-64 with certain underlying medical conditions or risk factors.3
Since the introduction of pneumococcal conjugate vaccines (PCV), non-PCV serotypes have increasingly caused IPD.1
The 15-valent pneumococcal conjugate vaccine showed immunogenicity against 15 serotypes including its unique ones and was well tolerated in immunocompetent patients with risk factors for IPD with the potential to broaden serotype coverage and protect against IPD.1