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Experimental Human Pneumococcal Carriage
Published on: February 15, 2013
13-valent pneumococcal conjugate vaccine (PCV13) in preterm versus term infants
Federico Martinón-Torres1, Hanna Czajka2, Kimberly J Center3
1Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela and Vaccine Research Unit, Genetics, Vaccines, Infections and Pediatrics Research Group (GENVIP), Healthcare Research Institute of Santiago, Santiago de Compostela, Spain; federico.martinon.torres@sergas.es.
Insights
Preterm infants showed lower immune responses to pneumococcal conjugate vaccine (PCV13) than term infants. However, both groups achieved protective antibody levels after the toddler dose, demonstrating PCV13
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Preterm infants represent a vulnerable population with potentially altered immune responses to vaccination.
- The 13-valent pneumococcal conjugate vaccine (PCV13) is crucial for preventing invasive pneumococcal disease.
Purpose of the Study:
- To compare the immunogenicity and safety of PCV13 in preterm versus term infants.
- To assess antibody concentrations and functional activity following PCV13 vaccination schedules.
Main Methods:
- Phase IV, open-label, multicenter study involving 200 healthy infants (100 preterm, 100 term).
- Infants received PCV13 at 2, 3, 4, and 12 months of age, alongside routine immunizations.
- Immune responses were measured by immunoglobulin G (IgG) antibody concentrations and opsonophagocytic activity.
Main Results:
- Most infants achieved protective IgG levels post-vaccination, though preterm infants had lower geometric mean concentrations initially.
- Antibody responses increased significantly after the toddler dose (TD) in both groups, with similar fold increases.
- PCV13 demonstrated a favorable safety profile, with no significant differences observed across preterm subgroups.
Conclusions:
- While preterm infants exhibit lower initial immune responses to PCV13, they achieve protective antibody levels, especially after the toddler booster dose.
- The timely administration of the toddler dose is critical for enhancing pneumococcal immunity in all infants.
- PCV13 is safe and well-tolerated in both preterm and term infants, irrespective of gestational age.
Objectives:
This study evaluated the immune response and safety profile of 13-valent pneumococcal conjugate vaccine (PCV13) in preterm infants compared with term infants.
Methods:
This Phase IV, open-label, 2-arm, multicenter, parallel-group study enrolled 200 healthy infants (preterm, n = 100; term, n = 100) aged 42 to 98 days. All subjects received PCV13 at ages 2, 3, 4 (infant series), and 12 (toddler dose [TD]) months, together with routine vaccines (diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine and meningococcal group C conjugate vaccine).
Results:
Most subjects achieved an anticapsular immunoglobulin G (IgG) antibody concentration ≥ 0.35 μg/mL for all serotypes: >85% after the infant series (except preterm infants for serotypes 5, 6A, and 6B) and >97% after TD (except for serotype 3). Preterm infants had overall lower IgG geometric mean concentrations compared with term infants; however, geometric mean fold increases after TD were similar for all serotypes. Opsonophagocytic activity results were consistent with IgG results and titers increased after TD in both groups for all serotypes, including serotype 3. PCV13 was generally well tolerated, with similar safety profiles in all preterm subgroups.
Conclusions:
Immune responses were lower in preterm infants than in term infants. However, the majority of subjects in both groups achieved both pneumococcal serotype-specific IgG antibody levels after the infant series that exceeded the World Health Organization-established threshold of protection and functional antibody responses. Responses were uniformly higher after TD, reinforcing the importance of a timely booster dose. PCV13 was well tolerated regardless of gestational age.
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