Respiratory syncytial virus, more commonly known as RSV, is a virus that can cause serious respiratory distress in young children and older adults and leads to about 177,000 hospitalizations in older adults and 14,000 deaths a year. Only one vaccine has been approved in high risk infants, but we still lack a preventative shot for high risk older adults, those with underlying health conditions or the broader population.
Moderna, a mid-sized pharma company focused on mRNA technologies and infectious disease vaccines, has a portfolio including preclinical through phase 3 trials in RSV vaccines for adults and pediatrics. In order to develop a strategic enrollment plan for the case driven phase 2 / 3 pivotal vaccine trial (ConquerRSV; NCT05127434) in adults aged >60, researchers needed to locate hot spots of RSV infection activity in the U.S. Claims data has a 1-3 month lag and hospital data wasn’t capturing community spread. Both of these data sources could lead to suboptimal information guiding patient enrollment.
Ovation provided RSV testing from our network of molecular labs across the U.S. to Moderna. We drew from historical and prospectively captured infection data between 2019-2022, which was updated on a real time basis and delivered weekly to the clinical development teams. This data included symptomatic and asymptomatic patients, which was a broader scope of infections than captured by claims or hospital data. The data was segmented by census bureau regions, HHS regions and included zip 3 granularity which was critical for enrollment planning. The ages of patients included in this dataset were broad, spanning infants, pediatrics and adults through the age of 89.
Ovation RSV testing data can be used to:
Guide enrollment strategies in large pivotal vaccine efficacy trials
Ensure timely data is available throughout enrollment period
Accelerate trial timelines in case-driven studies
Ovation’s real time RSV testing data at zip3 geographic specificity, in combination with other data sources, was used to track RSV test count and positivity rate from June 17, 2016 through Dec 24, 2022. These analyses were shared in a poster presentation at the World Vaccine Congress on April 4-6th, 2023.
Researchers concluded in the poster that “Developing internal surveillance systems for vaccines targeting pathogens with uncertain or seasonal variations can guide enrollment strategies in large pivotal efficacy trials and ensure that a timely source of data is available throughout the enrollment period. Implementation of optimal enrollment strategies may ensure maximum potential benefit for participants and accelerate trial timelines in case-driven studies, which may be especially important when there is an unmet medical need for a disease with a substantial health burden (i.e., RSV).”
A recent announcement regarding the effectiveness of mRNA-1345 RSV vaccine against lower respiratory tract disease in phase 3 trials helped Moderna gain breakthrough designation for its shot in older adults.