Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study

Santolaya, Marı́a Elena; O’Ryan, Miguel; Valenzuela, María Teresa; Prado, Valeria; Vergara, Rodrigo; Muñoz, Alma; Toneatto, Daniela; Graña, Gabriela; Wang, Huajun; Clemens, Ralf; Dull, Peter

doi:10.1016/s0140-6736(11)61713-3

Cited by 233 publications

(190 citation statements)

References 24 publications

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“…[19][20][21][22] Results from Phase 2 and 3 clinical studies demonstrated that 4CMenB elicited strong bactericidal responses against the vaccine antigens and was generally well tolerated when used in infants and children, adolescents and adults. [21][22][23][24][25][26] 4CMenB has been approved in the EU, Australia, Canada, Chile, and Uruguay for use in individuals beginning from 2 months of age and in the US for use in individuals 10 to 25 y of age.…”

Section: Introductionmentioning

confidence: 99%

Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in healthy adolescents

Sáez-Llorens

Vaca²,

Abarca

et al. 2015

Human Vaccines & Immunotherapeutics

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This phase 2 study assessed the immunogenicity, safety, and reactogenicity of investigational formulations of meningococcal ABCWY vaccines, consisting of recombinant proteins (rMenB) and outer membrane vesicle (OMV) components of a licensed serogroup B vaccine, combined with components of a licensed quadrivalent meningococcal glycoconjugate vaccine (MenACWY-CRM). A total of 495 healthy adolescents were randomized to 6 groups to receive 2 doses (Months 0, 2) of one of 4 formulations of rMenB antigens, with or without OMV, combined with MenACWY-CRM, or 2 doses of rMenB alone or one dose of MenACWY-CRM then a placebo. Immunogenicity was assessed by serum bactericidal assay with human complement (hSBA) against serogroups ACWY and serogroup B test strains; solicited reactions and any adverse events (AEs) were assessed. Two MenABCWY vaccinations elicited robust ACWY immune responses, with higher seroresponse rates than one dose of MenACWY-CRM. Bactericidal antibody responses against the rMenB antigens and OMV components were highest in subjects who received 2 doses of OMV-containing MenABCWY formulations, with 68% of subjects achieving hSBA titers 5 against each of the serogroup B test strains. After the first dose, solicited local reaction rates were higher in the MenABCWY or rMenB groups than the MenACWY-CRM group, but similar across groups after the second dose, consisting mainly of transient injection site pain. Fever ( 38.0 C) was rare and there were no vaccine-related serious AEs. In conclusion, investigational MenABCWY formulations containing OMV components elicited highly immunogenic responses against meningococcal serogroups ACWY, as well as serogroup B test strains, with an acceptable safety profile. [NCT01210885]

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Section: Introductionmentioning

confidence: 99%

Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in healthy adolescents

Sáez-Llorens

Vaca²,

Abarca

et al. 2015

Human Vaccines & Immunotherapeutics

Self Cite

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show abstract

“…The effectiveness of the vaccine was extrapolated from 4CMenB immunogenicity data reported by Vesikari et al 11 in infants and Santolaya et al 12 in healthy adolescents. We used the lowest immunogenicity observed after 3 doses of vaccine in infants (80%) 11 and one dose of the vaccine in adolescents (92%).…”

Section: Vaccine Effectivenessmentioning

confidence: 99%

“…We used the lowest immunogenicity observed after 3 doses of vaccine in infants (80%) 11 and one dose of the vaccine in adolescents (92%). 12 Cost-effectiveness analysis The effectiveness of the vaccination campaign was calculated comparing the number of averted MD cases, MD sequelae, and MD deaths per year to a scenario of no intervention. Expected cases as result of no intervention were calculated based on the observed cases rates per age group registered during the first year of the epidemic outbreak (1993).…”

Section: Vaccine Effectivenessmentioning

confidence: 99%

“…9,10 Using reverse vaccinology, protein based vaccines have been developed. [11][12][13] A multicomponent serogroup B meningococcal vaccine (4CMenB) has been developed including 4 recombinant proteins in addition to an outer membrane vesicle (OMV). 14, 15 Vesikari et al 11 demonstrated 84 to 100% protective immunogenicity of this vaccine in infants receiving immunization at 2, 4, and 6 months of age.…”

Section: Introductionmentioning

confidence: 99%

“…The tolerability profile was acceptable when administered together with routine childhood vaccines. Santolaya et al 12 assessed the immunogenicity of 4CMenB in different schedules of one, 2 or 3 doses in adolescents. The study showed a protective immune response in 92 to 97% adolescents after one dose, and 99 to 100% after 2 or 3 doses.…”

Section: Introductionmentioning

confidence: 99%

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