A phase 3, randomized, active-controlled study to assess the safety and tolerability of meningococcal serogroup B vaccine bivalent rLP2086 in healthy adolescents and young adults

Østergaard, Lars; Lucksinger, Gregg; Absalon, Judith; Beeslaar, Johannes; Eiden, Joseph; Jansen, Kathrin U.; York, Laura J.; Quinn, Angela; Graversen, Mette E.; Perez, John L.

doi:10.1016/j.vaccine.2016.01.044

Cited by 26 publications

(16 citation statements)

References 20 publications

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Section: Resultsmentioning

confidence: 99%

“…For the adolescent study, individuals aged 10‐18 years enrolled at sites across North America and Europe were randomly assigned to receive MenB‐FHbp (n = 2693) or control vaccine (hepatitis A virus vaccine [HAV]/saline; n = 897) at months 0, 2 and 6 (Table ). In a similar study performed in young adults, individuals aged 18‐25 years enrolled at sites across North America and Europe were randomly assigned to receive MenB‐FHbp (n = 2471) or saline (n = 822) at months 0, 2 and 6 .…”

Section: Resultsmentioning

confidence: 99%

“…For the safety study in adolescents and young adults, individuals aged 10‐25 years enrolled at sites across the United States, South America, Europe and Australia were randomly assigned to receive MenB‐FHbp (n = 3804) or HAV/saline (n = 1908) at 0, 2 and 6 months (Table ) . Serious AEs during the vaccination phase (months 0‐7) were rare both in control and MenB‐FHbp‐vaccinated subjects (1.8% and 1.2%, respectively).…”

Section: Resultsmentioning

confidence: 99%

“…Two pivotal studies, one in adolescents and another in young adults, evaluated immunogenicity via hSBA responses to four primary and 10 additional MenB test strains, as well as safety and tolerability 9. A third study evaluated safety and tolerability in both adolescent and young adult age groups 57. Across both studies, immuneresponses above the protective threshold (hSBA ≥1:8 or ≥1:16) were observed in 64.0%-99.0% and 86.4%-99.5% of MenB-FHbp recipients against the four primary representative test strains after the second and third vaccine doses, respectively; 82.7%-84.5% had responses against all 4 primary MenB test strains combined (ie composite responses).…”

mentioning

confidence: 99%

“…Rates for these events were generally highest following the first dose of the vaccination series 9. For the safety study in adolescents and young adults, individuals aged 10-25 years enrolled at sites across the United States,Table 3) 57. Serious AEs during the vaccination phase Newly diagnosed chronic medical conditions considered to be study related were rare in both the MenB-FHbp and HAV/saline groups (0.03% and 0.00%, respectively, during the vaccination phase).…”

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confidence: 99%

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A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB‐FHbp

Alderfer

Snow

2019

J Clin Pharm Ther

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What is known and objective This review describes invasive meningococcal disease (IMD) epidemiology in the United States, provides a brief overview of available meningococcal vaccines and discusses meningococcal serogroup B (MenB) vaccine development. Particular focus is given to the recombinant protein MenB vaccine, MenB‐FHbp (Trumenba®, bivalent rLP2086) in light of recent publication of phase 3 data; the other MenB vaccine (Bexsero®, MenB‐4C) has been recently reviewed. Current recommendations of the US Advisory Committee on Immunization Practices (ACIP) for MenB vaccination and potential barriers to immunization are also discussed. Methods Using the published literature, this article reviews the development and use of MenB‐FHbp to date, with a focus on the United States. Results and discussion Despite the availability of medical treatment, IMD is associated with significant mortality and frequently occurring serious permanent sequelae in surviving individuals. Worldwide, most IMD is caused by six serogroups (A, B, C, W, X and Y). MenB is the most common disease‐causing meningococcal serogroup in the United States and has caused several recent university‐based IMD outbreaks. MenB vaccines, including MenB‐FHbp, are available in the United States. ACIP recommends that all individuals ≥10 years of age at increased risk for meningococcal disease receive MenB vaccination; healthy individuals 16‐23 years of age are recommended MenB vaccines based on individual clinical decision‐making. MenB‐FHbp is used on a 2‐dose schedule (0, 6 months) when vaccinating healthy individuals and on a tailored 3‐dose schedule (0, 1‒2, 6 months) in cases of increased risk. What is new and conclusion Because vaccination provides the most effective protection against IMD, pharmacists are in an excellent position to offer evidence‐based vaccine information, as well as to encourage and provide meningococcal immunizations to adolescents and young adults.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB‐FHbp

Alderfer

Snow

2019

J Clin Pharm Ther

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Impfstoffe gegen Meningokokken für das Kindesalter

Tenenbaum

Hellenbrand

Schroten

2019

Monatsschr Kinderheilkd

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MenB-FHbp Meningococcal Group B Vaccine (Trumenba®): A Review in Active Immunization in Individuals Aged ≥ 10 Years

Shirley

Taha

2018

Drugs

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MenB-FHbp (bivalent rLP2086; Trumenba) is a recombinant protein-based vaccine targeting Neisseria meningitidis serogroup B (MenB), which has recently been licensed in the EU for active immunization to prevent invasive disease caused by MenB in individuals ≥ 10 years of age. The vaccine, which contains a variant from each of the two identified subfamilies of the meningococcal surface protein factor H-binding protein (fHBP), has been licensed in the USA for active immunization in individuals 10-25 years of age since 2014. This article reviews the immunogenicity, reactogenicity and tolerability of MenB-FHbp, with a focus on the EU label and the European setting. As demonstrated in an extensive program of clinical trials in adolescents and young adults, a two-dose or three-dose series of MenB-FHbp elicits a strong immune response against a range of MenB test strains selected to be representative of strains prevalent in Europe and the USA. Follow-up studies investigating the persistence of the MenB-FHbp immune response and the effect of a booster dose of the vaccine indicate that a booster dose should be considered (following a primary vaccine series) in individuals at continued risk of invasive meningococcal disease. MenB-FHbp vaccine appears to be moderately reactogenic but, overall, is generally well tolerated, with most adverse reactions being mild to moderate in severity. Although post-marketing, population-based data will be required to establish the true effectiveness of the vaccine, currently available data indicate that MenB-FHbp, in a two-dose or three-dose series, is likely to provide broad protection against MenB strains circulating in Europe.

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A phase 3, randomized, active-controlled study to assess the safety and tolerability of meningococcal serogroup B vaccine bivalent rLP2086 in healthy adolescents and young adults

Abstract: This safety study, the largest randomized, active-controlled trial evaluating a recombinant MnB vaccine, demonstrated that bivalent rLP2086 is safe and tolerable in healthy individuals ≥ 10 to < 26 years of age.

Cited by 26 publications

References 20 publications

A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB‐FHbp

A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB‐FHbp

Impfstoffe gegen Meningokokken für das Kindesalter

MenB-FHbp Meningococcal Group B Vaccine (Trumenba®): A Review in Active Immunization in Individuals Aged ≥ 10 Years

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