Synthetic IgM Antibody Controls for Measles, Mumps, and Rubella Assays

Phase I SBIR proposals will be accepted. Fast-track proposals will not be accepted. Phase I clinical trials will not be accepted. Number of anticipated awards: 1 Budget (total costs): Phase I up to $243,500 for up to 6 months; Phase II of up to $2,045,816 and a Phase II duration of up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Background Acute infections of measles, rubella, and mumps continue to place an undue burden on public health systems, especially in countries with nascent vaccine programs or logistical challenges for achieving high levels of vaccination coverage or disease surveillance. Measles infection leads to over 100,000 deaths globally each year, rubella infections can cause congenital rubella syndrome with over 100,000 cases estimated worldwide each year, and mumps infections can lead to serious complications such as meningitis and orchitis. In the United States, importation of measles and rubella occurs, occasionally leading to large-scale outbreaks in susceptible communities. Mumps is endemic in the United States and occasionally larger outbreaks occur. The accurate diagnosis of viral infections such as measles, mumps, and rubella are essential for effective public health response for routine testing and in outbreak situations. IgM antibodies are the first immunological response to infection, often making IgM detection crucial in the early diagnosis of these diseases. However, the availability of reliable IgM positive controls is limited, especially in countries where these diseases are eliminated, impacting the accuracy and standardization of diagnostic assays.