Concurrent 3-Vaccine Administration Can Cover 5 Serogroups in Meningococcal Disease
SAN DIEGO, CA—The bivalent rLP2086 meningococcal serogroup B vaccine coadministered with MCV4 and Tdap met noninferiority immunogenicity criteria without a clinically significant increase in reactogenicity, a study representing the first report of concomitant adolescent vaccination of all three vaccines concluded at IDWeek 2015.
Neisseria meningitidis is a leading cause of bacterial meningitis and septicemia in infants, adolescents, and young adults. Currently, quadrivalent capsular polysaccharide protein conjugate vaccines can prevent Serogroup A, C, Y, and W disease; however, “these are not effective against serogroup B,” said Derek Muse, MD, from Jean Brown Research, Salt Lake City, UT.
Dr. Muse and colleagues set out to determine if immune responses induced by coadministration of Menactra (meningococcal A, C, Y, W-135 polysaccharide conjugate vaccine [MCV4]) and Adacel (tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine [Tdap]) with Trumenba (meningococcal B [MnB, bivalent rLP2086] vaccine) were noninferior to MCV4 + Tdap or bivalent rLP2086 alone.
Bivalent rLP2086 comprises two recombinant lapidated fHBP variants from subfamily A (A05) and subfamily B (B01).
Study authors evaluated 2,624 healthy adolescents aged 10–<13 years of age who received MCV4 + Tdap + bivalent rLP2086 or MCV3 + Tdap, or bivalent rLP2086. The immunogenicity of bivalent rLP2086 was assessed by serum bactericidal assay through human complement (hsBA) with 2 MnB test strains expressing vaccine-heterologous fHBP variants. The immunogenicity of MCV4/Tdap antigens was assessed by multiplexed Luminex assays and/or rabbit SBAs.
Data showed that immune responses to MCV4 + Tdap + bivalent rLP2086 given concomitantly were noninferior to immune responses to MCV4 + Tdap or bivalent rLP2086 alone. One month after Dose 2, 62.3%–68.0% of patients had seroprotective hsBA titers to 2 MnB test strains, and 87.5%–90% of patients one month after Dose 3 of MCV4 + Tdap + bivalent rLP2086. Bivalent rLP2086 given alone also induced similar responses.
“Local reactions and systemic events were reported more frequently with administration of bivalent fLP2086 alone compared to administration of MCV4 + Tdap alone,” said Dr. Muse, who added that “these differences are not believed to be clinically meaningful.” Local reactions included redness, swelling, and pain, and systemic events, fever, headache, and fatigue. Incidence of adverse events did not differ among the groups.
“Coadministration did not significantly increase local reactions or systemic events compared to bivalent rLP2086 alone,” reported Derek Muse, MD, the study's lead author. Administration of MCV4 and MnB vaccines would provide coverage against the 5 serogroups responsible for the majority of meningococcal disease, and the administration convenience of concomitant vaccines may improve adherence to recommended schedules.