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. Issue 12 (14th March 2016)

• Record Type: Journal Article
• 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.
• Is Part Of: Vaccine. Volume 34:Issue 12(2016)
• Page Start: 1465
• Page End: 1471
• Publication Date: 2016-03-14
• Subjects: AE adverse event -- fHBP factor H binding protein -- HAV hepatitis A virus vaccine -- IMD invasive meningococcal disease -- MAE medically-attended adverse event -- MnB Neisseria meningitidis serogroup B -- NDCMC newly-diagnosed chronic medical condition -- SAE serious adverse event; Adolescents -- Meningitis -- Safety -- Vaccine -- Bivalent rLP2086; Vaccines -- Periodicals; 615.372
• DOI: 10.1016/j.vaccine.2016.01.044
• Languages: English
• ISSNs: 0264-410X

Abstract

Highlights: 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. Abstract: Background: 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. Methods: 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. Results: 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. Conclusion: 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.