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Updated: May 31, 2026
Experimental Human Pneumococcal Carriage
Published on: February 15, 2013
Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine
Félix Omeñaca1, Jose Manuel Merino, Juan-Carlos Tejedor
1Neonatal Unit, La Paz Hospital, Madrid, Spain.
Insights
The 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) is safe and effective in preterm infants. Immunization demonstrated robust antibody responses, comparable to full-term infants, supporting its use in this vulnerable population.
Area of Science:
- Pediatric Vaccinology
- Immunology
- Neonatal Health
Background:
- Preterm infants are at increased risk of invasive pneumococcal disease and other infections.
- The 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) offers protection against common serotypes.
- Assessing the safety and immunogenicity of PHiD-CV in preterm infants is crucial for public health recommendations.
Purpose of the Study:
- To evaluate the safety profile of PHiD-CV in preterm infants.
- To assess the immunogenicity of PHiD-CV in preterm infants compared to term infants.
- To determine immune responses following primary and booster doses of PHiD-CV.
Main Methods:
- A study involving three groups of infants: very preterm (gestation ≥27 to <31 weeks), moderately preterm (≥31 to <37 weeks), and term (≥37 weeks).
- Infants received a 3-dose primary immunization of PHiD-CV at 2, 4, and 6 months, followed by a booster dose at 16-18 months.
- Safety was monitored through solicited symptoms and adverse events; immunogenicity was measured via enzyme-linked immunosorbent assay (ELISA) antibody concentrations and opsonophagocytic activity (OPA) titers.
Main Results:
- PHiD-CV demonstrated a favorable safety profile, with similar incidence of general symptoms across groups and lower local reactions (redness, swelling) in preterm infants.
- The vaccine was highly immunogenic for all 10 pneumococcal serotypes and protein D, with high percentages of infants achieving protective antibody levels post-primary and post-booster doses.
- While some trends for lower post-primary antibody concentrations and OPA titers were observed in preterm infants for certain serotypes, post-booster responses were comparable between preterm and term groups.
Conclusions:
- The 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) is well-tolerated in preterm infants.
- PHiD-CV elicits robust immunogenicity in preterm infants, with significant antibody and opsonophagocytic activity booster responses in the second year of life.
- These findings support the use of PHiD-CV for preterm infants, providing comparable protection to that seen in term infants.
Objective:
The safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in preterm infants were assessed in this study.
Methods:
Three parallel groups of infants received 3-dose primary immunization with PHiD-CV at 2, 4, and 6 months of age and a booster dose at 16 to 18 months: preterm I (gestation period ≥ 27 and <31 weeks, N = 50); preterm II (≥31 and <37 weeks, N = 87); and term (≥37 weeks, N = 149). Solicited symptoms and adverse events were recorded. Immune responses to PHiD-CV and coadministered vaccine antigens were measured.
Results:
The incidence of solicited general symptoms was similar across groups, and the frequency of grade 3 general symptoms was low. Incidences of redness and swelling were generally lower in preterm infants. PHiD-CV was immunogenic for each of the 10 vaccine pneumococcal serotypes (postprimary, ≥92.7% of infants reached enzyme-linked immunosorbent assay antibody concentrations ≥ 0.2 μg/mL and postbooster, ≥97.6%) and for protein D, with a trend for lower postprimary geometric mean antibody concentrations and opsonophagocytic activity (OPA) titers in preterm infants for some pneumococcal serotypes. Postbooster, ≥91.9% of subjects in each group had an OPA titer ≥ 8 for each of the vaccine serotypes. Pneumococcal antibody concentrations and OPA titers after priming and booster vaccination were comparable between the 2 preterm groups.
Conclusions:
PHiD-CV was well tolerated and immunogenic in preterm infants when given as a 3-dose primary vaccination, with robust enzyme-linked immunosorbent assay antibody and OPA booster responses in the second year of life.
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