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Clinical Trial
. 2016 Jun;5(2):152-60.
doi: 10.1093/jpids/piv039. Epub 2015 Aug 4.

Meningococcal Serogroup B Bivalent rLP2086 Vaccine Elicits Broad and Robust Serum Bactericidal Responses in Healthy Adolescents

Timo Vesikari  1 , Lars Østergaard  2 , Javier Diez-Domingo  3 , Jacek Wysocki  4 , Carl-Erik Flodmark  5 , Johannes Beeslaar  6 , Joseph Eiden  7 , Qin Jiang  8 , Kathrin U Jansen  7 , Thomas R Jones  7 , Shannon L Harris  7 , Robert E O'Neill  7 , Laura J York  9 , Graham Crowther  6 , John L Perez  8
Affiliations
Clinical Trial

Meningococcal Serogroup B Bivalent rLP2086 Vaccine Elicits Broad and Robust Serum Bactericidal Responses in Healthy Adolescents

Timo Vesikari et al. J Pediatric Infect Dis Soc. 2016 Jun.

Abstract

Background: Neisseria meningitidis serogroup B (MnB) is a leading cause of invasive meningococcal disease in adolescents and young adults. A recombinant factor H binding protein (fHBP) vaccine (Trumenba(®); bivalent rLP2086) was recently approved in the United States in individuals aged 10-25 years. Immunogenicity and safety of 2- or 3-dose schedules of bivalent rLP2086 were assessed in adolescents.

Methods: Healthy adolescents (11 to <19 years) were randomized to 1 of 5 bivalent rLP2086 dosing regimens (0,1,6-month; 0,2,6-month; 0,2-month; 0,4-month; 0,6-month). Immunogenicity was assessed by serum bactericidal antibody assay using human complement (hSBA). Safety assessments included local and systemic reactions and adverse events.

Results: Bivalent rLP2086 was immunogenic when administered as 2 or 3 doses; the most robust hSBA responses occurred with 3 doses. The proportion of subjects with hSBA titers ≥1:8 after 3 doses ranged from 91.7% to 95.0%, 98.9% to 99.4%, 88.4% to 89.0%, and 86.1% to 88.5% for MnB test strains expressing vaccine--heterologous fHBP variants A22, A56, B24, and B44, respectively. After 2 doses, responses ranged from 90.8% to 93.5%, 98.4% to 100%, 69.1% to 81.1%, and 70.1% to 77.5%. Geometric mean titers (GMTs) were highest among subjects receiving 3 doses and similar between the 2- and 3-dose regimens. After 2 doses, GMTs trended numerically higher among subjects with longer intervals between the first and second dose (6 months vs 2 and 4 months). Bivalent rLP2086 was well tolerated.

Conclusions: Bivalent rLP2086 was immunogenic and well tolerated when administered in 2 or 3 doses. Three doses yielded the most robust hSBA response rates against MnB strains expressing vaccine-heterologous subfamily B fHBPs.

Trial registration: ClinicalTrials.gov NCT01299480.

Keywords: Neisseria meningitidis serogroup B; bivalent rLP2086; clinical trial; functional immunogenicity; safety.

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Figures

Figure 1.
Figure 1.
Subject disposition. *Values in this row used as denominators for percentages.
Figure 2.
Figure 2.
Percentage of subjects with hSBA titers ≥1:8 against N meningitidis serogroup B test strains A22, A56, B24, and B44 at baseline and 1 month after injection with bivalent rLP2086 or saline. Errors shown are 95% confidence intervals. hSBA, human serum bactericidal antibody assay using human complement.
Figure 3.
Figure 3.
Geometric mean titers (GMTs) against N meningitidis serogroup B test strains A22, A56, B24, and B44 at baseline and 1 month after injection with bivalent rLP2086 or saline.
Figure 4.
Figure 4.
Local injection-site reactogenicity (recorded by electronic diary [e-diary]). Data have been aggregated across groups to show reactogenicity after each dose.
Figure 5.
Figure 5.
Systemic reactogenicity (recorded by electronic diary [e-diary]). Data have been aggregated across groups to show reactogenicity after each dose. *Fever: 38.0–38.4°C = mild; 38.5–38.9°C = moderate; and ≥39°C = severe.
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