Concomitant administration of the meningococcal serogroup B vaccine bivalent rLP2086 with the diphtheria, tetanus, and acellular pertussis and inactivated poliovirus (DTaP/IPV) vaccine produced a immunologically noninferior response in adolescents, compared with administration of DTaP/IPV alone.
Timo Vesikari, MD, PhD, of the University of Tampere (Finland) Medical School and his associates randomized healthy adolescents aged 11-18 years to receive either bivalent rLP2086 plus DTaP/IPV (373 patients) or DTaP/IPV plus saline (376 patients). The researchers achieved the primary objective of the study – demonstrating the noninferiority of rLP2086 with DTaP/IPV. The lower bound of the two-sided 95% confidence interval for the difference in the proportion of responders between the two groups 1 month after the DTaP/IPV dose was greater than –10% for the nine DTaP/IPV antigens. Levels of antibodies to the DTaP/IPV antigens, measured as geometric means, also were similar between the vaccine groups for each antigen, according to the researchers.
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There also were substantial immune responses to bivalent rLP2086 plus DTaP/IPV, as measured with serum bactericidal assays using human complement (hSBAs) 1 month after the second vaccination, which increased even more after the third vaccination. The proportions of bivalent rLP2086-plus-DTaP/IPV recipients with prespecified seroprotective hSBA titers to the four meningococcal serogroup B test strains were between 55.5% and 97.3% after vaccination two and between 81.5% and 100% after vaccination three.
“Bivalent rLP2086 was well tolerated and elicited substantial and broad bactericidal responses to diverse [meningococcal serogroup B] strains in a high proportion of recipients after 2 vaccinations, and these responses were further enhanced after 3 vaccinations,” the researchers wrote.
Read the full study in the Journal of the Pediatric Infectious Diseases Society (2016 Jun;5[2]:180-7. doi: 10.1093/jpids/piv064).