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J Pediatric Infect Dis Soc. 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.

Author information

1
University of Tampere Medical School, Finland.
2
Department of Infectious Diseases, Aarhus University Hospital, Denmark.
3
Área de Investigación en Vacunas, FISABIO-Public Health, Universidad Católica de Valencia, Spain.
4
Department of Preventive Medicine, Poznań University of Medical Sciences, Poland.
5
Vaccine Unit, Department of Pediatrics, Skåne University Hospital, Malmo, Sweden.
6
Pfizer Ltd, Walton Oaks, Tadworth, United Kingdom.
7
Pfizer Vaccine Research, Pearl River, New York.
8
Pfizer Global Vaccines, Collegeville, Pennsylvania.
9
Pfizer Medical and Scientific Affairs, Collegeville, Pennsylvania.

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

PMID:
26407272
PMCID:
PMC5407127
DOI:
10.1093/jpids/piv039
[Indexed for MEDLINE]
Free PMC Article

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