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Similar antibody levels found among 4 PCV13 immunization schedules

Issue: October 2013

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Differences in antibody levels for all serotypes after a 13-valent pneumococcal conjugate vaccine booster dose after different immunization schedules were not statistically significant, according to recent study findings published in JAMA.

“WHO estimated that more than 800,000 children younger than 5 years died of pneumococcal disease in 2000, making it the leading vaccine-preventable cause of death,” according to study background information. “Since the licensure of the first 7-valent pneumococcal polysaccharide conjugate vaccine (PCV7) for infants, many countries have added PCV to their existing national immunization programs.”

The randomized clinical trial included 400 infants assigned to the 13-valent pneumococcal conjugate vaccine (Prevnar, Pfizer) at aged 2, 4 and 6 months (2-4-6); 3 and 5 months (3-5); 2, 3 and 4 months (2-3-4); or 2 and 4 months (2-4), with a booster dose at age 11.5 months.

Researchers found that 1 month after the booster dose, differences in antibody geometric mean concentrations were not statistically significant. For serotype 18C, the 2-4-6 schedule was superior (10.2 mcg/mL; 95% CI, 8.2-12.7) to the 2-3-4 schedule (6.5 mcg/mL; 95% CI, 5.4-7.8). This was also true for serotype 23F (2-4-6 schedule: 10.9 mcg/mL; 95% CI, 9.0-13.3 vs. 2-3-4 schedule: 7.3 mcg/mL; 95% CI, 5.8-9.2). The 2-4-6 schedule was also superior to the 2-4 schedule for serotypes 6B (8.5 mcg/mL; 95% CI, 7.1-10.2 vs. 5.1 mcg/mL; 95% CI, 3.8-6.7), 18C (6.6 mcg/mL; 95% CI, 5.7-7.7), and 23F (7.2 mcg/mL; 95% CI, 5.9-8.8). However, the 3-5 schedule was superior to all of the others for serotype 1 (11.7 mcg/mL; 95% CI, 9.6-14.3).

“The use of four different PCV13 immunization schedules in healthy term infants resulted in no statistically significant differences in antibody level after the booster dose at 12 months of age for almost all serotypes,” researchers wrote. “The choice of PCV schedule will require a balance between the need for early protection and maintaining protection before herd effects offer clinical protection against vaccine serotype disease to as yet unvaccinated or incompletely vaccinated infants.”

In an accompanying editorial, Katherine L. O’Brien, MD, MPH, of Johns Hopkins Bloomberg School of Public Health, wrote that, “Immunogenicity is just one aspect of biological effect, perhaps more important for some serotypes than others,” she wrote. “Focus should remain squarely on ensuring that every child is immunized with at least three doses of PCV, beginning early in life and administered in a timely fashion.”

For more information:

• O’Brien KL. JAMA. 2013;doi:10.1001/jama.2013.228062.
• Spijkerman J. JAMA. 2013;doi:10.1001/jama.2013.228052.

Disclosure: Two researchers report various financial ties with GlaxoSmithKline and Pfizer. O’Brien reports receiving research grant support from GlaxoSmithKline and Pfizer, and she has served on advisory groups for Merck, GlaxoSmithKline and Aventis-Pasteur.