IDCRC Investigator Profile: Hana M. El Sahly, MD

Baylor College of Medicine Vaccine and Treatment Evaluation Unit (VTEU) PI

Associate Professor, Molecular Virology and Microbiology and PI, Vaccine and Treatment Evaluation Unit (VTEU), Baylor College of Medicine

Hana M. El Sahly, MD has been an infectious diseases physician and clinical researcher for the past 18 years. Her research experience focuses on clinical vaccine development in healthy populations, and also in elderly persons, persons infected with HIV and persons at risk of acquiring HIV. These include vaccines against respiratory pathogens, especially influenza, biodefense agents, and malaria. She serves on the Coronavirus and Respiratory Infections IDCRC Expert Working Groups. She is currently the chair of the Food and Drug Administration Vaccine and Related Biological Advisory Committee.

How long have you been with the VTEU?

I started working with the VTEU in 2004, under the mentorship of Wendy Keitel, MD. My first VTEU project was a protocol evaluating two routes of administering a live tularemia vaccine. I learned rigorous fundamentals of study design and execution through trouble shooting many of the twists and turns this protocol took.

Briefly describe the IDCRC-supported trials you've recently led.

In 2020, I led the performance of ACTT 1/2/3 at Baylor College of Medicine (BCM), closely working with Jeni Whitaker, MD, MSc who was instrumental in the success of these projects. We recently received activation to implement ACTT-4. I am also the protocol co-chair of COVID-19 Prevention Network (CoVPN) 3001, the Phase 3 clinical trial testing the efficacy of mRNA-1273, Moderna’s COVID-19 vaccine. Additional projects include a SARS-CoV-2 seroprevalence study, and testing SARS-CoV-2 monoclonal antibodies as prophylaxis/early treatment in nursing homes.

Of these trials, what has been the most impactful or highlight of the work?

I have been fortunate to partake in ACTT. The data we generated led to the licensure and FDA emergence use authorization (EUA) of two products that will likely help millions of patients. At a personal level, I learned a lot from the energetic and bright minds of my national and international co-investigators on the study. It may sound weird, but ACTT Thursday call is a ZOOM call I am always excited to join.

The results of the Phase 3 clinical trial testing the efficacy of mRNA-1273 have also led to an EUA of the vaccine, and determining the long-term effects of this vaccine is a public health question that will keep us busy and generate yet more impactful data.

What is a strength or example of the importance of the IDCRC during the pandemic and beyond?

Respiratory viruses pathogenesis and vaccine development have always been a VTEU priority. The leadership within the NIH Division of Microbiology and Infectious Diseases (DMID) and IDCRC and the investigators’ expertise made the COVID-19 treatment and prevention trials that much better. One example is determining the primary endpoint of the Phase 3 vaccine studies. It may seem like a given, but this one point required many deliberations and changes, and the IDCRC vision of this point made the success of the Phase 3 studies possible. An IDCRC achievement that goes beyond this pandemic is the ability to launch non-COVID-19 expert working groups and projects. These will set the stage for the clinical research agenda for 2021 and beyond.