RATIONALE FOR STUDY. Vaccination remains the most cost-effective strategy available to combat influenza. Current influenza vaccines work by inducing strain-specific antibodies against the highly polymorphic surface proteins of the influenza virus. The need for constant redesign and remanufacture increases the vaccine’s cost, places limitations on supply and critically delays vaccine production when new strains arise. There is therefore a major demand for improved vaccination strategies that can provide protection against a broad spectrum of virus strains. Previous studies have demonstrated the safety of MVA-NP+M1 across different age groups, including older adults and in combination with seasonal influenza vaccine; the immunogenicity of MVA-NP+M1 in older adults given alone and in combination with licensed inactivated seasonal influenza vaccine; and the effect of MVA-NP+M1 in limiting the severity of influenza illness in adults. This study will therefore investigate the immunogenicity and efficacy in terms of viral and symptom endpoints in a large number of healthy adults aged 18 and over when given as an adjunct to standard QIV. This MVA-NP+M1, produced using the novel immortalised duck retinal cell line AGE1.CR.pIX®, also addresses the scalability issues of CEF manufactured vaccines.
RATIONALE FOR STUDY. A number of studies have been conducted examining school nutrition policies, practices, and environments, but none have specifically examined low-income schools in Georgia or explicitly employed the SEM as a framework for comparing these aspects among school-level demographic characteristics. Additionally, a number of researchers have conducted related studies (i.e., with different age groups, in different locations, etc.) which provided evidence for each of the chosen SEM constructs of interest. The current study investigates Georgia SNAP-Ed school nutrition policies, practices, and environments in relation to the school-level construct of the SEM, including geography, FRL, percent Caucasian, and cohort year.
RATIONALE FOR STUDY. Dengue is caused by 4 distinct types of RNA viruses (DENV-1, DENV-2, DENV-3, and DENV-4) belonging to the flavivirus genus. Although a vaccine is available, its efficacy is variable between the different serotypes and it is only indicated for individuals with a history of previous DENV infection. There are no effective therapeutics for dengue, and treatment options are limited to supportive care such as fluid replacement and clinical monitoring. A safe and effective antiviral therapy that targets all DENV serotypes is greatly needed to reduce the global burden of this disease and meet this unmet medical need. Atea Pharmaceuticals is developing a novel purine nucleotide prodrug, AT-752, which is designed to treat patients that have been infected with the DENV. Supported by tolerability/safety and PK in healthy subjects (see Section 1.2.1), the next logical development step for a dengue treatment is to evaluate safety, antiviral activity and PK/PD relationships of differing doses of AT-752 in DENV-infected patients. This study will evaluate the safety, PK, and PD of AT-752 in adult patients with confirmed DENV infection and further support dose selection for subsequent, later phase trials.
RATIONALE FOR STUDY. This study is being conducted as an FDA post marketing commitment to the approved New Drug Application for TPOXX. SIGA is required to conduct a study to determine the pharmacokinetic (PK) profile of TPOXX in subjects with a body weight greater than 120 kilograms (>120 kg) to determine if a change in dosing regimen would be needed in these patients.
RATIONALE FOR STUDY. This study will compare the effect of varying degrees of hepatic impairment on the PK, safety, and tolerability of a single oral dose of 600 mg (2 × 300-mg tablets) aramchol in Part 1 and multiple oral doses not to exceed 300 mg twice daily for 11 days and a single 300 mg AM dose on Day 12 in Part 2 with healthy subjects. Hepatic impairment associated with cirrhosis may develop in subjects with XXXX. Therefore, it is important to assess the effect of hepatic impairment on the PK and hence dosage requirements and safety of aramchol.
