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Experimental Human Pneumococcal Carriage
Published on: February 15, 2013
Immunogenicity of 13-valent pneumococcal conjugate vaccine administered according to 4 different primary immunization
Judith Spijkerman1, Reinier H Veenhoven, Alienke J Wijmenga-Monsuur
1Department of Pediatric Immunology and Infectious Diseases, Wilhelmina Children's Hospital, University Medical Centre, Utrecht, The Netherlands. j.spijkerman@umcutrecht.nl
Insights
Four pneumococcal conjugate vaccine (PCV13) schedules showed similar antibody levels post-booster in infants. Choosing a PCV13 schedule requires balancing early protection with sustained immunity between doses.
Area of Science:
- Pediatrics
- Immunology
- Vaccinology
Background:
- Immunization schedules for pneumococcal conjugate vaccine (PCV) vary globally in dosage and timing.
- Optimizing PCV schedules is crucial for effective infant immunization.
Purpose of the Study:
- To compare the immunogenicity of four different 13-valent pneumococcal conjugate vaccine (PCV13) primary immunization schedules in infants.
- To determine the optimal PCV13 vaccination schedule for infants.
Main Methods:
- A randomized clinical trial involving 400 healthy term infants in the Netherlands.
- Infants received PCV13 at different ages: 2, 4, 6 months (2-4-6); 3, 5 months (3-5); 2, 3, 4 months (2-3-4); or 2, 4 months (2-4), followed by a booster at 11.5 months.
- Antibody geometric mean concentrations (GMCs) against PCV13 serotypes were measured post-booster and at other time points.
Main Results:
- No significant differences in antibody GMCs were observed between schedules for most serotypes one month after the booster dose.
- The 2-4-6 schedule showed superiority for specific serotypes (18C, 23F, 6B) compared to 2-3-4 and 2-4 schedules.
- Differences in antibody levels were noted after the primary series, with the 2-4-6 schedule performing better for several serotypes.
Conclusions:
- Different PCV13 schedules yield comparable antibody levels after the booster dose in healthy infants.
- The selection of a PCV schedule should consider the balance between achieving early protection and maintaining immunity between the primary series and booster.
- Further research may be needed to determine the long-term implications of varying PCV schedules.
Importance:
Immunization schedules with pneumococcal conjugate vaccine (PCV) differ among countries regarding the number of doses, age at vaccinations, and interval between doses.
Objective:
To assess the optimal primary vaccination schedule by comparing immunogenicity of 13-valent PCV (PCV13) in 4 different immunization schedules.
Design, Setting, And Participants:
An open-label, parallel-group, randomized clinical trial of healthy term infants in a general community in The Netherlands conducted between June 30, 2010, and January 25, 2011, with 99% follow-up until age 12 months.
Interventions:
Infants (N = 400) were randomly assigned (1:1:1:1) to receive PCV13 either at ages 2, 4, and 6 months (2-4-6); at ages 3 and 5 months (3-5); at ages 2, 3, and 4 months (2-3-4); or at ages 2 and 4 months (2-4), with a booster dose at age 11.5 months.
Main Outcomes And Measures:
Primary outcome measure was antibody geometric mean concentrations (GMCs) against PCV13-included serotypes 1 month after the booster dose measured by multiplex immunoassay. Secondary outcomes included GMCs measured 1 month after the primary series, at 8 months of age, and before the booster.
Results:
The primary outcome, GMCs at 1 month after the booster dose, was not significantly different between schedules for 70 of 78 comparisons. The 2-4-6 schedule was superior to the 2-3-4 schedule for serotypes 18C (10.2 µg/mL [95% CI, 8.2-12.7] vs 6.5 µg/mL [95% CI, 5.4-7.8]) and 23F (10.9 µg/mL [95% CI, 9.0-13.3] vs 7.3 µg/mL [95% CI, 5.8-9.2]) and superior to the 2-4 schedule for serotypes 6B (8.5 µg/mL [95% CI, 7.1-10.2] vs 5.1 µg/mL [95% CI 3.8-6.7]), 18C (6.6 µg/mL [95% CI, 5.7-7.7]), and 23F (7.2 µg/mL [95% CI, 5.9-8.8]). For serotype 1, the 3-5 schedule (11.7 µg/mL [95% CI, 9.6-14.3]) was superior to the other schedules. Geometric mean concentrations for all 13 serotypes ranged between 1.6 and 19.9 µg/mL. Secondary outcomes demonstrated differences 1 month after the primary series. The 2-4-6 schedule was superior compared with the 3-5, 2-3-4, and 2-4 schedules for 3, 9, and 11 serotypes, respectively. Differences between schedules persisted until the booster dose.
Conclusions And Relevance:
The use of 4 different PCV13 immunization schedules in healthy term infants resulted in no statistically significant differences in antibody levels after the booster dose for almost all serotypes. The choice of PCV schedule will require a balance between the need for early protection and maintaining protection between the primary series and the booster.
Trial Registration:
trialregister.nl Identifier: NTR2316.
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