MedicalResearch.com Interview with:
Judith Absalon, M.D., M.P.H
Senior Director, Vaccines Clinical Research
MedicalResearch.com: What is the background for these two studies?
Response: Invasive serogroup B meningococcal disease (MenB) is uncommon, yet serious, is unpredictable and can strike at any age, including healthy teenagers and young adults, with potentially long-lasting and devastating consequences, including death. The data from these two Phase 3 studies, one in adolescents (Study 1009) and one young adults (Study 1016), highlight that Trumenba can help protect teens and young adults against meningococcal group B disease.
Additionally, these two large Phase 3 studies confirmed the results of earlier studies and supported the transition from Accelerated to Traditional Approval in the US; were pivotal for approvals in Europe, Australia, and Canada earlier this year; and add to the growing portfolio of research for TRUMENBA.
MedicalResearch.com: What are the main findings of the two studies?
Response: Data from both studies demonstrate that TRUMENBA elicits a protective immune response against diverse MenB strains representative of prevalent strains causing invasive MenB in the US and Europe after two and three doses of vaccine. In the studies, TRUMENBA, administered on a three-dose schedule (0, 2, and 6 months), demonstrated immunogenicity against four primary MenB strains representative of strains causing invasive disease and 10 additional diverse MenB strains. These studies met all five co-primary immunogenicity endpoints against a panel of diverse test strains.
MedicalResearch.com: What should readers take away from your report?
Response: MenB, while uncommon, is a serious disease. It is unpredictable, and early symptoms of meningococcal disease can be misinterpreted as the flu often making it difficult to diagnose, and can lead to death within 24 hours. Prevention is key to helping protect against this disease. This extensive dataset underscores the ability of TRUMENBA to help protect against the diverse strains that can cause MenB and specifically demonstrates the immunogenicity of TRUMENBA in eliciting protective immune responses against MenB. Additionally, Trumenba is generally well tolerated; the most common solicited adverse reactions in adolescents and young adults were pain at the injection site, fatigue, headache, and muscle pain.
The data from these published studies can assist vaccine technical committees and other public health authorities as they consider recommendations for the use of TRUMENBA in adolescents and young adults.
Additionally, readers should know that Trumenba helps protect against MenB disease and that an additional vaccine, MenACWY or quadrivalent meningococcal conjugate vaccine, is recommended for protection against serogroups A, C, W and Y. Together these vaccines can help protect against the most common serogroups causing meningococcal disease globally.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: As part of the post-marketing commitment for Trumenba in the US, we are currently evaluating the immunogenicity, safety, and tolerability of TRUMENBA as a two-dose series (0 and 6 months) against diverse MenB strains in a Phase 3 trial. Both the two-dose (0, 6 month) and three-dose (0, 1-2, and 6 month) schedule of TRUMENBA was initially granted Accelerated Approval based on Phase 2 clinical trials. We also continue to study the persistence of immune response following the recommended two- or three-dose schedules of Trumenba.
MedicalResearch.com: Is there anything else you would like to add?
Response: Although uncommon, MenB may result in life-altering, significant long-term and permanent medical disabilities, including brain damage, vision loss, motor impairment, speech problems, and limb amputation. MenB affects all age groups, but incidence is highest among infants, adolescents and young adults. Adolescents and young adults are an important age group for prevention against MenB due to inherent environmental and social risk factors such as close-quartered living and sharing behaviors. Up to a quarter of adolescents may be asymptomatic carriers of Neisseria meningitidis – the bacteria that causes MenB. Given what we believe is the importance of increasing understanding of MenB, we are pleased to see these data published in the New England Journal of Medicine, and that it reinforces the ability of TRUMENBA to help protect against the diverse MenB strains that can cause this devastating disease.
2017 has been a momentous year for TRUMENBA to help protect against MenB. In May, the vaccine achieved approval in Europe, followed by approvals in Australia and Canada. Also in May, the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) provided updated recommendations for TRUMENBA and now recommends a two-dose series (administered at 0 and 6 months) and a three-dose series (administered at 0, 1‐2, and 6 months), depending on the patient’s risk for exposure and susceptibility to MenB.
It’s also important to highlight that any vaccine is only effective if people complete the series.
Unfortunately, about one in every two adolescents who start a MenB series do not complete it, as studied during a 12-month tracking period for a cohort of patients younger than 18 years of age who were administered their first dose between January and June 2016 and were tracked through June 2017. By not completing the MenB schedule, people may not get the full protective benefits of the vaccine, leaving themselves vulnerable to serious and potentially life-threatening disease.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Lars Ostergaard, M.D., Ph.D., Timo Vesikari, M.D., Ph.D., Judith Absalon, M.D., M.P.H., Johannes Beeslaar, M.D., Brian J. Ward, M.D., C.M., Shelly Senders, M.D., Joseph J. Eiden, M.D., Ph.D., Kathrin U. Jansen, Ph.D., Annaliesa S. Anderson, Ph.D., Laura J. York, Ph.D., Thomas R. Jones, Ph.D., Shannon L. Harris, Ph.D., Robert O’Neill, Ph.D., David Radley, M.S., Roger Maansson, M.S., Jean-Louis Prégaldien, M.S., John Ginis, B.S., Nina B. Staerke, M.D., and John L. Perez, M.D., for the B1971009 and B1971016 Trial Investigators*
N Engl J Med 2017; 377:2349-2362
December 14, 2017DOI: 10.1056/NEJMoa1614474
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.