Safety and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared to Those of a 7-Valent Pneumococcal Conjugate Vaccine Given as a Three-Dose Series with Routine Vaccines in Healthy Infants and Toddlers

Abstract

A 13-valent pneumococcal conjugate vaccine (PCV13) has been developed to improve protection against pneumococcal disease beyond that possible with the licensed 7-valent vaccine (PCV7). This study compared the safety and immunogenicity of PCV13 with those of PCV7 when given as part of the pediatric vaccination schedule recommended in Italy. A total of 606 subjects were randomly assigned to receive either PCV13 or PCV7 at 3, 5, and 11 months of age; all subjects concomitantly received diphtheria-tetanus-acellular pertussishepatitis B-inactivated polio-Haemophilus influenzae type B (DTaP-HBV-IPV/Hib) vaccine. Vaccine reactions were monitored. Antibody responses to DTaP-HBV-IPV/Hib antigens, serotype-specific anticapsular polysaccharide IgG responses, and antipneumococcal opsonophagocytic assay (OPA) activity were measured 1 month after the two-dose primary series and 1 month after the toddler dose. Overall, the safety profile of PCV13 was similar to that of PCV7. The response to DTaP-HBV-IPV/Hib antigens was substantially the same with both PCV13 and PCV7. PCV13 elicited antipneumococcal capsular IgG antibodies to all 13 vaccine serotypes, with notable increases in concentrations seen after the toddler dose. Despite a lower immunogenicity for serotypes 6B and 23F after the primary series of PCV13, responses to the seven common serotypes were comparable between the PCV13 and PCV7 groups when measured after the toddler dose. PCV13 also elicited substantial levels of OPA activity against all 13 serotypes following both the infant series and the toddler dose. In conclusion, PCV13 appeared comparable to PCV7 in safety profile and immunogenicity for common serotypes, demonstrated functional OPA responses for all 13 serotypes, and did not interfere with immune responses to concomitantly administered DTaP-HBV-IPV/Hib vaccine.

Natural Antibodies against Several Pneumococcal Virulence Proteins in Children during the Pre-Pneumococcal-Vaccine Era: the Generation R Study

“…However, the net vaccine benefit has been negatively affected by a 71% increased rate of invasive pneumococcal disease caused by nonvaccine serotypes (30). Recently, a 13-valent pneumococ-cal conjugate vaccine (PCV-13) was developed to further improve protection (9,19) by covering the serotypes that most frequently cause infection and colonization. However, the increase in carriage of nonvaccine serotypes, and the associated increase in invasive disease, could ultimately outweigh the benefits of the current PCV (21).…”

13-valent pneumococcal conjugate vaccine immune sera protects against pneumococcal serotype 1, 3, and 5 bacteremia in a neonatal rat challenge model

“…[18][19][20][21] WHO ELISA responder rates at 0.35 μg/ mL for the non-PCV7 serotypes of PCV13 were also compared to those of PCV7. In addition, exploratory analyses demonstrated that functional antibody titers were elicited by all the additional serotypes of PCV13.…”

Cost-effectiveness analysis of 10- and 13-valent pneumococcal conjugate vaccines in Peru

“…PCV10 added three additional serotypes-1, 5 and 7F-plus a Non-Typeable Haemophilus influenzae (NTHi) protein carrier that could protect against AOM [11]. PCV13 covers an additional three-3, 6A and 19A (i.e., six more than PCV7) [12]. Evidence shows that their safety and immunogenicity profiles of these higher valences vaccines are similar to that of PCV7 and they do not interference with other vaccines in young children [11,12].…”

“…PCV13 covers an additional three-3, 6A and 19A (i.e., six more than PCV7) [12]. Evidence shows that their safety and immunogenicity profiles of these higher valences vaccines are similar to that of PCV7 and they do not interference with other vaccines in young children [11,12]. Since these two higher valence vaccines differ in serotypes covered, NTHi protein carrier, and unit price per dose, their impact as a public health intervention could differ.…”