Safety and Immunogenicity of a Booster Dose of the 10-Valent Pneumococcal Nontypeable Haemophilus Influenzae Protein D Conjugate Vaccine Coadministered With DTPW-HBV/Hib and Poliovirus Vaccines

Abstract

The safety and reactogenicity profiles of the 10-valent pneumococcal conjugate vaccine, PHiD-CV, and 7vCRM were comparable within the Philippines and Poland when coadministered as a booster dose with DTPw-HBV/Hib and poliovirus vaccines to toddlers primed with the same vaccines. Robust immune responses for all 10 vaccine pneumococcal serotypes and protein D following PHiD-CV booster vaccination were indicative of effective priming.

Safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Chilean children

“…This was in line with previous experience with PHiD-CV primary and booster vaccination studies, 12,14,15,17 in which SAEs considered causally related to PHiD-CV vaccination occurred rarely and resolved without sequelae.…”

“…Moreover, the reactogenicity profile of PHiD-CV was consistent with previous experience with coadministration of pneumococcal conjugate and DTPa-based combination vaccines 19 and with reactogenicity observations from previous PHiD-CV studies. 14,15,17 As seen previously for other vaccines, 20,21 we observed higher immune responses in Chilean infants and toddlers compared to those in previous European PHiD-CV studies, 11,13,16,18 although these differences seemed to be less pronounced for OPA and post-booster responses. 11,14,[16][17][18] Overall, anti-pneumococcal IgG responses following 2-dose PHiD-CV catch-up vaccination between 18 and 23 months of age were consistent with those measured after 3-dose PHiD-CV priming, with comparable percentages of subjects with antibody concentrations ≥0.2 μg/ml and antibody GMCs within the same range or higher following catch-up immunization, except for serotypes 5, 6B and 23F.…”

“…27 Antibody responses against the NTHi protein D carrier protein were in line with those measured in previous PHiD-CV trials. 11,13,14,16,17 The potential to address both pneumococcal and NTHi diseases with PHiD-CV is significant as both pathogens are important causes of bacterial acute otitis media (AOM). 28,29 In a study with an 11-valent protein D conjugate vaccine formulation, significant protective efficacy was reported for episodes of AOM caused by pneumococcal vaccine serotypes and by NTHi.…”

“…[8][9][10] Previous primary and booster studies showed that PHiD-CV is immunogenic and safe when co-administered with other routine pediatric vaccines. [11][12][13][14][15][16][17][18] The present study, conducted in Chile, assessed the safety (primary objective) and immunogenicity (secondary objective) of 2 PHiD-CV immunization regimens: a 3-dose PHiD-CV primary immunization course administered at 2, 4 and 6 months of age followed by a booster dose at 20 to 23 months of age and a 2-dose PHiD-CV catch-up immunization schedule at 18 to 21 and 20 to 23 months of age.…”

Public health impact of pneumococcal conjugate vaccine infant immunization programs: assessment of invasive pneumococcal disease burden and serotype distribution

“…However, vaccine effectiveness of PHiD-CV has been observed against 19A IPD [12][13][14] and 6A IPD [83], possibly due to crossreactivity by functional antibodies induced by the VTs 19F and 6B. Indeed, PHiD-CV induced functional (opsonophagocytic) antibodies to 19A and 6A after primary and booster vaccination [84][85][86][87][88][89][90]. In comparative studies between PHiD-CV and PCV7 (for which limited or no protection against 19A disease has been observed) [91], 19A opsonophagocytic activity responses were substantially higher after PHiD-CV than after PCV7 vaccination [84][85][86][87][88][89][90].…”