Safety and Immunogenicity of Pneumococcal Conjugate Vaccine in Preterm Infants: A Meta-Analysis.

OBJECTIVE: To assess the safety and immunogenicity of pneumococcal conjugate vaccine (PCVs) in preterm infants.

METHODS: In accordance with the PRISM (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement (as of May 2015), a meta-analysis was conducted to evaluate the safety and immunogenicity of PCVs in preterm infants.

RESULTS: Ten thousand nine hundred sixty full-term infants and 2131 preterm infants with 344 preterm infants of <2500 g birth weight [low-birth weight (LBW)] were included, and all the subjects were immunized with either PCV-7, PCV-10 or PCV-13 in this random-effects meta-analysis. For safety, the range of risk ratio (RRs) for local reaction was from 0.88 to 1.02 and from 0.94 to 1.24 for systematic reaction respectively. For immunogenicity, either post-primary or booster vaccination with PCV-7, PCV-10 or PCV-13, genomic mean concentration (GMC) of serotypes 4, 6B, 9 V, 19F and 23F was always less in preterm infants than in full-term infants, in which huge comparison of GMC was found in serotype 19F(SMD = -0.393, 95%CI:-0.612 ~ 0.175). After primary vaccination, the combined risk ratio (RRs) of immune response against seven common serotypes and additional serotype 1 was approximated to 1.00 with narrow 95 % confidence interval (CI) between preterm infants and full-term infants, and at least 91 % sero-conversion of two additional serotypes, 5 and 7F in two cohorts was observed. Furthermore, between very-low-birth-weight (VLBW) infants of <1500 g and 1501 ~ 2500 g, overall RRs of immune response to PCV-7 administration was 0.98 (95%CI: 0.96 ~ 1.00).

CONCLUSIONS: Preterm infants have a great tolerance to PCV-7, PCV-10 or PCV-13 vaccination. PCV-7 could elicit optimal immune response post vaccination in preterm infants, even in VLBW infants.