Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in a High-risk Population: A Randomized Controlled Trial of 10-Valent and 13-Valent Pneumococcal Conjugate Vaccine in Papua New Guinean Infants

Abstract

Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed.

Immunogenicity and reactogenicity of ten-valent versus 13-valent pneumococcal conjugate vaccines among infants in Ho Chi Minh City, Vietnam: a randomised controlled trial

“…PCV10 and PCV13 have been shown to be immunologically non-inferior to the first-licensed, seven-valent PCV (PCV7),5, 6, 7 but there are few data directly comparing PCV10 with PCV13, despite these vaccines having been available for several years. A trial from Papua New Guinea compared three doses of PCV10 and PCV13 administered at 1 month, 2 months, and 3 months of age, with immunogenicity data obtained prevaccination, after dose three, and at 9 months of age 8 . Two European trials of investigational next-generation pneumococcal vaccines have included control groups of both PCV10 and PCV13, administered in a 3 + 1 schedule at 2 months, 3 months, 4 months, and 12–15 months of age, with immunogenicity data obtained post-primary series, pre-booster, and post-booster 9, 10.…”

“…Serotype-specific geometric mean concentrations (GMCs) of IgG antibody after vaccination with PCV13 tend to be higher post-primary series, lower pre-booster, and higher post-booster than GMCs after PCV10 vaccination, although these trends do not hold for all serotypes. Notably, of these studies, only the Papua New Guinean study 8 and the Dutch study 11 of the booster response were designed specifically to evaluate differences in the immunogenicity of the two vaccines.…”

Immunogenicity and Immune Memory after a Pneumococcal Polysaccharide Vaccine Booster in a High-Risk Population Primed with 10-Valent or 13-Valent Pneumococcal Conjugate Vaccine: A Randomized Controlled Trial in Papua New Guinean Children

“…These are relevant findings considering that in high-risk settings most pneumococcal disease and deaths occur in the first two years of life, and the coverage afforded by PCV10 and PCV13 is limited due to the broad range of pneumococcal serotypes colonizing and causing disease (for example, less than 50% of IPD serotypes in PNG are contained in PCV13) [3,4,5]. PCV10 and PCV13, like the earlier 7-valent vaccine, are also associated with an increase in disease due to non-vaccine serotypes [20], which in particular in high-risk settings could reduce the impact afforded by these vaccines.…”

“…The trial consisted of two parts. The aim of the first part (results reported elsewhere [5]) was to assess safety, immunogenicity and antibody persistence after PCV10 or PCV13 vaccination at 1, 2 and 3 months of age during the first 9 months of life in Papua New Guinean infants. The objectives of the second part of this study, reported here, include (1) assessing the immunogenicity and antibody persistence of PPV given at 9 months of age in children primed with PCV10 or PCV13, and (2) assessing the capacity of PPV-vaccinated compared to PPV-naive children to respond to a pneumococcal exposure by measuring IgG antibody responses produced in response to a pneumococcal challenge given in the form of a micro-dose of PPV (1/5th the normal dose) at 23 months of age.…”

“…Infants in Papua New Guinea (PNG), experience one of the highest rates of pneumococcal infections worldwide. We have recently shown in a head-to-head study that the two currently available pneumococcal conjugate vaccines (PCV), the 10-valent (PCV10) and 13-valent (PCV13) vaccines, are comparably safe and immunogenic in PNG infants when given at 1, 2 and 3 months of age in line with national guidelines [5]. However, while more than 90% of infants vaccinated as part this trial produced seroprotective antibody levels against most vaccine serotypes one month after the 3rd dose of PCV10 or PCV13, antibody levels waned rapidly between 4 and 9 months of age.…”