13-valent Pneumococcal Conjugate Vaccine in Older Children and Adolescents Either Previously Immunized With or Naive to 7-valent Pneumococcal Conjugate Vaccine

From the *Department of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH
The Pediatric Infectious Disease Journal (Impact Factor: 2.72). 10/2013; 33(2). DOI: 10.1097/INF.0000000000000056
Source: PubMed


The 13-valent pneumococcal conjugate vaccine (PCV13) has been demonstrated to be immunogenic and safe for administration to infants and children aged <5 years. PCV13 recently was approved for children and adolescents aged up to 17 years as the vaccine may be of benefit to some in this older age group.
In this open-label study, healthy children aged ≥5 to <10 years (ie, the younger age group) previously vaccinated (≥1 dose) with 7-valent pneumococcal conjugate vaccine (PCV7) and pneumococcal vaccine-naïve children aged ≥10 to <18 years (ie, the older age group) received 1 dose of PCV13. For the younger group, antipneumococcal immunoglobulin (Ig) G geometric mean concentrations (GMCs) 1 month postvaccination were compared with posttoddler dose (PCV13 or PCV7) levels from a historical control study. Opsonophagocytic activity (OPA) geometric mean titers (GMTs) 1 month postvaccination for the older group were compared with the younger age group. Safety data were collected.
598 children were enrolled, 299 in each age group. For PCV7 serotypes, IgG GMCs in the younger group were 8.23-53.56 µg/mL, ≥2.5-fold greater than historical posttoddler dose values. For the 6 additional serotypes, IgG GMCs in the younger group were 2.38-21.51 µg/mL, ≥1.2-fold greater than historical posttoddler dose values. OPA GMTs were similar in the older and younger age groups, except for serotype 3 which was lower in the older group. Safety was comparable in both groups.
PCV13 was immunogenic and safe when administered to older children and adolescents, regardless of prior PCV7 vaccination.

1 Follower
16 Reads
  • [Show abstract] [Hide abstract]
    ABSTRACT: Background: Pneumococcal conjugate vaccine (PCV) antibody persistence and immunologic memory responses may be indicative of protection in previously vaccinated children. In children vaccinated in a previous study with an infant/toddler regimen of 4 doses of PCV7, 4 doses of PCV13, or 3 doses of PCV7 (infant series) and a dose of PCV13 (toddler dose), this follow-on study evaluated antibody persistence ≥24 months after the toddler dose, and immunogenicity and safety of a follow-on dose of PCV13. Methods: Children ≥3 years of age who had completed the initial study received 1 dose of PCV13 in this phase 3, open-label follow-on study in France. Serotype-specific anticapsular immunoglobulin G (IgG) and functional opsonophagocytic activity (OPA) were compared across the previous study vaccination groups, before, 4-7 days (IgG only), and 1 month after follow-on vaccination. Safety was assessed. Results: Before follow-on vaccination, IgG and OPA levels for the PCV7 serotypes were comparable across vaccination groups, but were generally higher for the 6 additional serotypes in children who received PCV13 in the previous study. At both time points after the follow-on vaccination, IgG and OPA values for all 13 serotypes increased, those for the PCV7 serotypes were similar across vaccination groups, but concentrations for the additional serotypes were higher in children who had received PCV13 in the previous study. PCV13 was well-tolerated. Conclusions: Antibody persistence and rapid responses after a follow-on dose of PCV13 suggest that even a single toddler dose of PCV13 is likely to provide protection against the 6 additional PCV13 serotypes.
    No preview · Article · Aug 2014 · The Pediatric Infectious Disease Journal
  • [Show abstract] [Hide abstract]
    ABSTRACT: Introduction: Globally, the three main pathogens causing serious infections are Haemophilus influenzae type b, Streptococcus pneumoniae and Neisseria meningitidis. Over the last 5 years, new vaccines protecting against these bacteria have been developed and introduced in various countries. Areas covered: This review describes the recently licensed glycoconjugates being used to protect against these encapsulated bacteria. Immunogenicity and safety data that led to licensure or licensure expansion of these glycoconjugates are discussed in addition to the resultant impact on the disease burden. Expert opinion: The maintenance of robust immunisation programmes with high uptake rates is important in maintaining low rates of disease. Epidemiological surveillance systems are essential in monitoring any changes in infectious disease trends and in identifying emerging infections such as from non-typeable H. influenzae, pneumococcal serotype replacement disease and changes in the epidemiology of meningococcal serogroups. This is important to guide future vaccine development. Accessibility of these glycoconjugate vaccines in resource poor regions, which bear the highest disease burden from these pathogens, remains challenging largely due to high vaccine pricing. Recent aids from public and private funding, tiered vaccine pricing and the transfer of vaccine technology have helped in introducing these vaccines where they are most needed.
    No preview · Article · Dec 2014 · Expert Opinion on Biological Therapy
  • [Show abstract] [Hide abstract]
    ABSTRACT: Streptococcus pneumoniae infections are a major cause of morbidity and mortality in children <5 years old worldwide. To increase serotype coverage globally, a 13-valent pneumococcal conjugate vaccine (PCV13) has been developed and approved in many countries worldwide. Assess the safety and immunogenicity of PCV13 in healthy older infants and children naïve to previous pneumococcal vaccination. This was a phase 3, open-label, multicenter study conducted in Polish children (N=354) who were vaccinated according to 3 age-appropriate catch-up schedules: Group 1 (aged 7 to <12 months) received two PCV13 doses with a booster at 12-16 months of age; Group 2 (aged 12 to <24 months) received two vaccine doses only; and Group 3 (aged 24 to <72 months) received a single dose of PCV13. Statistical analyses were descriptive. The proportion of immunological "responders" achieving serotype-specific antipneumococcal polysaccharide concentrations ≥0.35μg/mL, 1-month after the last dose of vaccine, was determined for each vaccine serotype. In addition, antipolysaccharide immunoglobulin (Ig) G geometric mean concentrations (GMCs) were calculated. Safety assessments included systemic and local reactions, and adverse events. The proportion of immunological responders was ≥88% across groups for all serotypes. Antipolysaccharide IgG GMCs were generally similar across groups. Each schedule elicited immune response levels against all 13 serotypes comparable to or greater than levels previously reported in infants after a 3-dose series. The 3 catch-up schedules had similar tolerability and safety profiles; a trend was present towards greater local tenderness with increasing age and subsequent dose administration. Immunological responses and safety results support the use of PCV13 for catch-up schedules in older infants and children naïve to pneumococcal vaccination. Copyright © 2015. Published by Elsevier Ltd.
    No preview · Article · Feb 2015 · Vaccine
Show more