Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in ≥56-year-olds: A Phase III randomized study.

BACKGROUND: Invasive meningococcal disease has a high mortality rate in individuals aged ≥56 years, but no vaccine is currently licensed in the USA for this age group. This study assessed the safety and immunogenicity of an investigational quadrivalent meningococcal tetanus toxoid conjugate vaccine (MenACYW-TT) compared with a meningococcal quadrivalent polysaccharide vaccine (MPSV4) in this age group. METHODS: This was a Phase III, modified double-blind, randomized, non-inferiority study (NCT02842866) across 35 clinical sites in the USA and Puerto Rico in individuals aged ≥56 years. A single dose of the MenACYW-TT (n = 451) or MPSV4 vaccine (n = 455) was administered on Day 0. A serum bactericidal assay with human (hSBA) and baby rabbit (rSBA) complement was used to measure antibodies against serogroups A, C, W, and Y test strains at baseline and Day 30. Safety data were collected up to six months post-vaccination. RESULTS: The seroresponse to MenACYW-TT was non-inferior to MPSV4 for each of the serogroups (A: 58.2% vs. 42.5%; C: 77.1% vs. 49.7%; W: 62.6% vs. 44.8%, Y: 74.4% vs. 43.4%, respectively). At Day 30, participants achieving hSBA titers ≥1:8 were higher for all serogroups after MenACYW-TT vs. MPSV4 (77.4-91.7 vs. 63.1-84.2%, respectively). No safety concerns were identified for either vaccine. CONCLUSION: MenACYW-TT was well-tolerated and immunogenic in ≥56-year-olds, offering the potential to replace MPSV4 in this age group.

A coordinated national model for diabetes prevention: linking health systems to an evidence-based community program.

BACKGROUND: Twenty-six million U.S. adults have diabetes, and 79 million have prediabetes. A 2002 Diabetes Prevention Program research study proved the effectiveness of a lifestyle intervention that yielded a 58% reduction in conversion to type 2 diabetes. However, cost per participant was high, complicating efforts to scale up the program. PURPOSE: UnitedHealth Group (UHG) and the YMCA of the USA, in collaboration with the CDC, sought to develop the infrastructure and business case to scale the congressionally authorized National Diabetes Prevention Program nationwide. Emphasis was placed on developing a model that maintained fidelity to the original 2002 Diabetes Prevention Program research study and could be deployed for a lower cost per participant while yielding similar outcomes. DESIGN: The UHG created the business case and technical and operational infrastructure necessary for nationwide dissemination of the YMCA's Diabetes Prevention Program (YMCA's DPP), as part of the National Diabetes Prevention Program. The YMCA's DPP is a group-based model of 16 core sessions with monthly follow-up delivered by trained lifestyle coaches. SETTING/PARTICIPANTS: A variety of mechanisms were used to identify, screen, and encourage enrollment for people with prediabetes into the YMCA's DPP. INTERVENTION: Substantial investments were made in relationship building, business planning, technology, development, and operational design to deliver an effective and affordable 12-month program. The program intervention was conducted July 2010-December 2011. Data were collected on the participants over a 15-month period between September 2010 and December 2011. Data were analyzed in February 2012. MAIN OUTCOME MEASURES: The main outcome measures were infrastructure (communities involved and personnel trained); engagement (screening and enrollment of people with prediabetes); program outcomes (attendance and weight loss); and service delivery cost of the intervention. RESULTS: In less than 2 years, the YMCA's DPP was effectively scaled to 46 communities in 23 states. More than 500 YMCA Lifestyle Coaches were trained. The program enrolled 2369 participants, and 1723 participants completed the core program at an average service-delivery cost of about $400 each. For those individuals completing the program, average weight loss was about 5%. UHG anticipates that within 3 years, savings from reduced medical spending will outweigh initial costs. CONCLUSIONS: Large-scale prevention efforts can be scalable and sustainable with collaboration, health information technology, community-based delivery of evidence-based interventions, and novel payment structures that incentivize efficiency and outcomes linked to better health and lower future costs.