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

• Published in: Vaccine Vol. 34; no. 12; pp. 1465 - 1471
• Main Authors: Ostergaard, Lars, Lucksinger, Gregg H., Absalon, Judith, Beeslaar, Johannes, Eiden, Joseph, Jansen, Kathrin U., York, Laura J., Quinn, Angela, Graversen, Mette E., Perez, John L.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 14.03.2016; Elsevier Limited
• Subjects: Adolescent; Adolescents; Adult; Age; Allergy and Immunology; binding proteins; Bivalent rLP2086; Child; Drug-Related Side Effects and Adverse Reactions; Female; Hepatitis; Hepatitis A Vaccines - administration & dosage; Hepatitis A virus; Hepatovirus A; Humans; Immunization; Internationality; Male; Meningitis; Meningococcal Infections - prevention & control; Meningococcal Vaccines - administration & dosage; Meningococcal Vaccines - adverse effects; Mortality; Neisseria meningitidis; Neisseria meningitidis, Serogroup B; Safety; safety assessment; serotypes; Standard deviation; Teenagers; United States; vaccination; Vaccine; Vaccines; Vaccines, Synthetic - administration & dosage; Vaccines, Synthetic - adverse effects; Young Adult; Young adults; United States > US; USA; United States; MnB; IMD; AE; NDCMC; Vaccine; MAE; Bivalent rLP2086; SAE; Meningitis; Safety; HAV; Adolescents; fHBP; invasive meningococcal disease; adverse event; medically-attended adverse event; hepatitis A virus vaccine; serious adverse event; factor H binding protein; Neisseria meningitidis serogroup B; newly-diagnosed chronic medical condition
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2016.01.044

•Largest controlled safety study of a recombinant meningococcal serogroup B vaccine.•SAEs occurred in lower percentage of bivalent rLP2086 group than control group.•SAEs related to vaccine were rare.•Rates of medically-attended AEs were similar between vaccine groups.•Bivalent rLP2086 was safe and tolerable in adolescents and young adults 10–25 years. Neisseria meningitidis serogroup B (MnB) is an important cause of invasive meningococcal disease (IMD). A MnB vaccine (bivalent rLP2086, Trumenba®) consisting of 2 factor H binding protein variants received accelerated approval in the United States for the prevention of IMD caused by MnB in individuals 10–25 years of age. This randomized, active-controlled, observer-blind study further assessed the safety and tolerability of bivalent rLP2086. Eligible subjects ≥10 to <26 years were randomized (2:1) to receive bivalent rLP2086 at months 0, 2, and 6, or hepatitis A virus vaccine (HAV, Havrix®) at months 0 and 6, and saline at month 2. The primary endpoints were serious adverse events (SAEs) throughout the study and medically-attended adverse events (MAEs) within 30 days after vaccination. Additional safety assessments included SAEs at other study intervals and adverse events (AEs) during the vaccination phase. Of 5712 subjects randomized, 84.6% (n=3219) of bivalent rLP2086 recipients and 87.2% (n=1663) of HAV/saline recipients completed the study. Throughout the study, SAEs were reported for 1.6% and 2.5% of bivalent rLP2086 and HAV/saline recipients, respectively. SAEs related to either vaccine were rare. MAEs occurred in 7.0% and 6.1% of subjects after vaccination 1; 5.5% and 6.1% after vaccination 2; and 5.3% and 5.5% after vaccination 3 in the bivalent rLP2086 and HAV/saline groups, respectively. A greater proportion of subjects reported AEs during the vaccination phase after bivalent rLP2086 compared with HAV/saline recipients; however, when reactogenicity events were excluded, the proportion between groups was similar. 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.