GMP manufacture of Shigella flexneri 2a Artificial Invaplex (Invaplex) and evaluation in a Phase 1 Open-label, dose escalating study administered intranasally to healthy, adult volunteers.

Shigella species cause severe disease among travelers to, and children living in, endemic countries. Although significant efforts have been made to improve sanitation, increased antibiotic resistance and other factors suggest an effective vaccine is a critical need. Artificial Invaplex (Invaplex) is a subunit vaccine approach complexing Shigella LPS with invasion plasmid antigens.

Osteopathic treatment in addition to standard care in patients with Gastroesophageal Reflux Disease (GERD) - A pragmatic randomized controlled trial.

Background: Long-term Proton Pump Inhibitor use is associated with low response rates and the risk of adverse events.

Objective: The objective of this study was to assess the effectiveness of Osteopathic Treatment in patients with Gastroesophageal Reflux Disease (GERD).

Methods: This study was a randomized controlled trial with a series of osteopathic interventions and an untreated control group.

Clinical yield of multiple testing with respiratory pathogen panels.

Unlabelled: Though multiplex respiratory pathogen panels (RPP) have high sensitivity, multiple tests are occasionally performed simultaneously or in rapid succession in an attempt to increase the yield. The purpose of this study was to assess the impact of this practice.

Methods: "Multiple testing" was defined as >1 RPP performed within 12 hours on the same patient and specimen type.

Establishment of a Controlled Human Infection Model with a Lyophilized Strain of Shigella sonnei 53G.

Controlled human infection models (CHIMs) are useful for vaccine development. To improve on existing models, we developed a CHIM using a lyophilized preparation of strain 53G produced using current good manufacturing practice (cGMP). Healthy adults were enrolled in an open-label dose-ranging study.

Clinical endpoints in the controlled human challenge model for Shigella: A call for standardization and the development of a disease severity score.

Background: Since 1946 the controlled human infection model (CHIM) for Shigella has been used to improve understanding of disease pathogenesis, describe clinical and immunologic responses to infection and as a tool for vaccine development. As the frequency and intent for use in vaccine comparisons increases, standardization of the primary endpoint definition is necessary.

Methods: Subject-level data were obtained from previously conducted experimental Shigella CHIM studies.