Schedules for Pneumococcal Vaccination of Preterm Infants: An RCT

Abstract

on behalf of the PUNS Study Group abstract BACKGROUND AND OBJECTIVE: Premature infants have a higher risk of invasive pneumococcal disease and are more likely to have lower vaccine responses compared with term infants. Increasingly, immunization schedules are including a reduced, 2-dose, pneumococcal conjugate vaccine priming schedule. Our goal was to assess the immunogenicity of 3 commonly used 13-valent pneumococcal conjugate vaccine (PCV13) priming schedules in premature infants and their response to a 12-month booster dose.

Safety of meningococcal group B vaccination in hospitalised premature infants

“…For comparison, adverse reactions after vaccine administration were compared with data from a historical cohort of premature infants who had received their primary immunisations without 4CMenB in similar NNUs across England as part of a randomised controlled trial assessing different pneumococcal vaccination schedules (’Prems Under New Schedule', PUNS) 14. In the PUNS study, infants were vaccinated by the study team after obtaining written informed consent from parents.…”

Invasive Pneumococcal Disease in UK Children <1 Year of Age in the Post–13-Valent Pneumococcal Conjugate Vaccine Era: What Are the Risks Now?

“…We found a significant proportion of infants who developed PCV13-type IPD were delayed with their pneumococcal vaccinations, emphasising the importance of timely immunisation in this vulnerable group [13,14,24]. Of the PCV13 serotypes causing IPD, serotypes 19A and 3 were overrepresented in term and preterm infants.…”

“…However, given the increased incidence of IPD in premature infants, any reductions in the priming schedule will require careful monitoring in this vulnerable group. In a previous study a two-dose infant priming schedule in premature infants resulted in significantly lower geometric mean concentrations for 12 of the PCV13 serotypes compared with infants receiving 3 doses and, prior to the 12-month booster, very few infants had protective antibody concentrations against more than half the PCV13 serotypes [14]. No clinical trial has been undertaken to assess a single priming dose in premature infants.…”

“…Among 3-59 month-olds, 10% of children with IPD had been born prematurely and 15% had an underlying co-morbidity [12]. Premature infants have reduced antibody responses to pneumococcal conjugate vaccination compared with those born at term [13], and these responses are dependent on the primary vaccination schedule received [14].…”

Pneumococcal Vaccines in Preterm Infants: Are More Doses Better? Implications for Other Vaccines

“…Vaccine schedules vary between countries, in part based on when disease risk is highest, the available vaccines, the population for which the recommendation is intended, programmatic considerations such as the timing of health visits, and in some cases, but not always, a detailed understanding of the immune response. As illustrated in the current study of conjugated pneumococcal vaccine in preterm infants, 3 there is room to learn more about the immune response to vaccines to refine our vaccine policies, and we will not all come up with the same answers.…”