BALTIMORE — Trumenba, a bivalent vaccine for prevention of Neisseria meningitidis serogroup B, appears to safely elicit a robust bactericidal response among adolescents and young adults, according to a pair of phase 3 trials recently presented at the Pediatric Academic Societies Meeting.
Approved by the FDA in 2014, Trumenba (rLP2086, Pfizer) is a three-dose series targeting factor H binding proteins (fHBP), according to the researchers. The CDC’s Advisory Committee on Immunization Practices (ACIP) currently recommends the vaccine be routinely given to at-risk persons aged older than 10 years, and considered for those aged 16 to 23 years in need of short-term meningococcal protection.
In the first trial conducted by Timo Vesikari, MD, PhD, professor at the University of Tampere Medical School, Finland, and colleagues, healthy adolescents aged 10 to 18 years randomly received either the bivalent meningococcal serogroup B (MnB) vaccine at 0, 2 and 6 months, or a hepatitis A virus vaccine at 0 and 6 months and a saline solution at 2 months. Primary outcomes included the proportion of participants with a fourfold or greater increase in fHBP titers for each of the four primary MnB test strains, and the proportion of participants achieving a composite response, defined as hSBA titers greater than or equal to the lower limit of quantification for all test strains combined. Researchers assessed responses with serum bactericidal assays using human complement. Safety and consistency between the three distributed vaccine lots also were evaluated.
Among the 2,693 participants who received the MnB vaccine series, 79.8% to 90.2% achieved the desired hSBA titers 1 month after their third dose against each primary strain, while 83.5% achieved a composite response. At 1 month after the second dose, 55.9% to 84.4% achieved the immunogenicity endpoint for each strain, and 54.1% demonstrated a composite response. Similar mean responses were observed among all three of the vaccine lots, and few serious adverse events were reported.
A similar study was conducted by Lars Østergaard, MD, PhD, of the clinical medicine and infectious diseases departments of Aarhus University Hospital, Denmark, and colleagues examining the same regimen, outcomes and methodology among 2,471 healthy participants aged 18 to 25 years. Among these, 79.3% to 90% receiving the MnB vaccine achieved a fourfold or greater hSBA titer increase 1 month after the third dose against each primary strain, while 84.9% achieve a composite response. After the second dose, 55.5% to 85.9% of participants showed a response against each strain, while 64.5% had a composite response. There were few serious adverse events, according to the researchers, and most local reactions and systemic events with the vaccine were mild or moderate.
Updated versions of these two studies also were presented by the researchers at the European Society for Pediatric Infectious Diseases Meeting (ESPID), according to a Pfizer press release. Along with reconfirming the previously reported data in a larger sample, these findings also suggest similar immune responses against 10 more MnB strains within both age groups.
“In addition to the data which assessed immune responses to four primary MnB test strains, representative of prevalent strains in the U.S. and Europe, the ESPID data show Trumenba helps protect against additional epidemiologically diverse MnB test strains in adolescents and young adults,” Kathrin Jansen, PhD, senior vice president and head of vaccine research and development for Pfizer, told Infectious Disease News. “These 10 additional test strains were chosen to reflect the diversity of MnB disease strains circulating in these regions.
“These phase 3 data support upcoming global regulatory submissions, as well as the planned U.S. supplement to request the conversion of accelerated approval to traditional approval for Trumenba.” – by Dave Muoio
Østergaard L, et al. Abstract ePS12. Presented at: European Society for Pediatric Infectious Diseases Meeting; May 10-14, 2016; Brighton, U.K.
Østergaard L, et al. Abstract 1505.460. Presented at: Pediatric Academic Societies Meeting; April 30-May 3, 2016; Baltimore.
Vesikari T, et al. Abstract OPS10. Presented at: European Society for Pediatric Infectious Diseases Meeting; May 10-14, 2016; Brighton, U.K.
Vesikari T, et al. Abstract 1505.459. Presented at: Pediatric Academic Societies Meeting; April 30-May 3, 2016; Baltimore.
Disclosure: Researchers from both studies report sponsorship from Pfizer, which develops the bivalent vaccine.