Other Research Projects
Bacteriophages (phages) have been minimally used in emergency clinical applications for skin and soft tissue infections and disseminated bacterial infections, but not to-date as an aerosol strategy against pulmonary mycobacteria. One limitation in the field preventing these advancements is the availability of a reproducible preclinical model of aerosol phage delivery that can be leveraged for efficacy testing. Importantly, our preliminary proof-of-concept results1 (read the paper) suggest that aerosol delivery of phage to mice can significantly reduce bacterial burden after challenge with Mtb. Our lab is actively collaborating to develop reproducible aerosol models of delivery and answer longstanding biological questions about phage treatment in vivo.
A Phase 1, Randomized, Placebo Controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of the Sm-p80 + GLA-SE (SchistoShield®) Vaccine in Healthy Adults
DMID Protocol Number: 18-0018
DMID Funding Mechanism: Vaccine and Treatment Evaluation Units
The study is a Phase 1, randomized, blinded, placebo controlled, dose escalation clinical trial to evaluate the safety, tolerability, and immunogenicity of the Sm-p80 + GLA-SE vaccine candidate in 48 healthy adults. Four treatment groups will be evaluated: A) 100 μg Sm-p80 (unadjuvanted), B) 10 μg Sm-p80 + 5 μg GLA-SE, C) 30 μg Sm-p80 + 5 μg GLA-SE, and D) 100 μg Sm-p80 + 5 μg GLA-SE. Each group will include nine subjects randomized to receive the Sm-p80 product and three subjects to receive placebo and all subjects will receive three intramuscular (IM) injections of 0.5 mL of the designated study product, on Days 1, 29, and 57 (28 days apart).
- Carrigy NB, Larsen SE, Reese V, Pecor T, Harrison M, Kuehl PJ, Hatfull GF, Sauvageau D, Baldwin SL, Finlay WH, Coler RN, Vehring R. Prophylaxis of Mycobacterium tuberculosis H37Rv Infection in a Preclinical Mouse Model via Inhalation of Nebulized Bacteriophage D29. Antimicrob Agents Chemother. 2019 Sep 16;63(12):e00871-19. doi: 10.1128/AAC.00871-19. Epub ahead of print. PMID: 31527037; PMCID: PMC6879268.