in Article: Influenza virus persists as an infectious threat, with the annual rise of seasonal influenza and a history of multiple pandemics. Moreover, the existence of multiple animal reservoirs of influenza viruses provides a source for future pandemic viruses, emphasizing the need for a One Health approach to address this pathogen. Current influenza vaccines protect against seasonal influenza, but are largely strain specific, providing little protection against diverse virus strains. The creation of a vaccine capable of providing broad protection against multiple influenza virus strain will enhance immunity against diverse influenza viruses, reducing the morbidity and mortality of this infection. A Phase II study performed by researchers at UTMB, sponsored and overseen by the National Institute for Allergy and Infectious Disease, will test the safety and efficacy of the BPL-1357 vaccine in human subjects.
The BPL-1357 vaccine is a two dose, four-component, inactivated vaccine designed by Dr. Jeffrey Taubenberger of the National Institute of Allergy and Infectious Diseases (NIAID). The BPL-1357 vaccine trial team is comprised of Dr. Matthew Memoli (NIAID), Professor Gregory C. Gray (principal investigator at UTMB), Professor Susan McLellan (UTMB), Professor Peter Melby (UTMB), Dr. Claudia Trujillo (UTMB), Dr. Diego Silva (UTMB), Lamonne Crutcher (UTMB), Elizabeth Hennessy (UTMB), Professor Michael Kinsky (UTMB), Dr. Corri Levine (UTMB), Dr. Lyudmyla Marushchak (UTMB), Malinda Ruelas (UTMB), Lori Simon (UTMB), and Elizabeth Welch (UTMB).
Dr. Susan McLellan (center) with Nigerian colleagues at their special pathogens treatment unit in Jos (Image Credit: Dr. Susan McLellan)
Dr. Susan McLellan is a professor at the University of Texas Medical Branch and Director of the Special Pathogens Excellence in Clinical Treatment, Readiness, and Education (SPECTRE) Program. The goals of SPECTRE are to support preparedness for special pathogens in the clinical care of patients, training of healthcare workers, promotion of research, and networking with other healthcare and public health entities. Dr. McLellan and SPECTRE further research on special pathogens by helping investigators formulate clinically relevant research questions and develop the procedures, connections, and institutional infrastructure to conduct such studies.
As a part of this Phase II BPL-1357 study, Dr. McLellan and SPECTRE will use the Biocontainment Care Unit (BCU) at UTMB to house patients for the live human challenge studies, which will include over 120 patients over a year. The goal of this project is to identify the main causes of AUFS. Dr. McLellan explained that the BCU at UTMB is a specialized unit for the care of highly infectious pathogens, such as Ebola. Fortunately, it is rarely needed for the care of such patients. However, it provides a highly controlled environment for the influenza challenge studies. Challenge studies, in which a healthy volunteer is intentionally infected with a pathogen to test the efficacy of a vaccine or therapy, allows for investigator control of the timing of the infection, the dose of the infection, and clear documentation of the time course and severity of any symptoms that result, as well as the collection of other clinically relevant variables, such as virus shedding and peak virus titers. This work will be done in collaboration with from the Office of Clinical Research and the Clinical Research Center at UTMB.
SPECTRE logo (Photo credit: SPECTRE: Special Pathogens Excellence in Clinical Treatment Readiness & Education Program"
This study looks to assess the prevention of mild-moderate influenza disease in patients by vaccination with BPL-1357. Two intervention groups, vaccinated either by the intramuscular or intranasal route, will be compared with a placebo group. Following a two-dose vaccination series, study participants will be challenged with a human 2015 seasonal-like H1N1 strain. This strain was selected because participants likely have partial immunity to this virus. The data collected as part of the human challenge portion of this study will include virus shedding (quantity, timing), symptoms, other clinically relevant variables, and aerosol sampling.
Dr. McLellan sees this project as having wide implications, not only for a successful influenza vaccine, but also for the work of SPECTRE and the BCU. She emphasized that this work is not just limited to SPECTRE, but the entire team of organizations involved in this project. This study, in the spirit of research SPECTRE seeks to support, is translational research that incorporates multiple players, including scientists involved in both basic and clinical research, and incorporates opportunities for biospecimen, as well as clinical data, collection. We are excited to see the contributions of this interdisciplinary work to furthering influenza vaccine strategies.