The LID Clinical Studies Unit (CSU) seeks to perform translational research studies to answer fundamental questions regarding human influenza and other emerging viral infections to inform and impact future vaccine and therapeutic design, while also making an effort to assist in evaluation of novel products that may impact human health. With a focus on healthy volunteer research, the LID CSU has been able to continue their primary work on influenza while quickly able to respond to assist in research of emerging infections.

The LID CSU reinvigorated influenza healthy volunteer challenge studies in 2011 after a decade absence of these studies in the U.S. The 2009 H1N1 influenza challenge virus made by the LID CSU was the first under an FDA IND and the LID CSU influenza challenge model has become the primary focus of the group. The LID CSU continues to make new influenza challenge viruses, develop validated models, and serves as a worldwide leader in establishing methods and standards for performing influenza and other challenge studies. The LID CSU challenge studies have been instrumental in further elucidating human pathogenesis of influenza infections and identifying correlates of protection and predictors of severe disease.

In addition, in recent years the LID CSU has initiated efforts to perform uncommon and difficult, but necessary clinical studies for the purposes of evaluating novel vaccines and therapeutics particularly universal influenza vaccines in the human challenge model and extremely novel universal vaccines for vector borne disease like Dengue, Zika, and Leishmaniasis.

Translating science from bedside to bench and then back to the bedside in the form of a product that can prevent or treat an infection is an extremely important part of the development of future impactful vaccines and therapeutics. Studies such as those carried out by the LID CSU play a key role in this process that will lead to improved prevention and mitigation of epidemics, pandemics, and emerging infections.

Dr. Memoli is a graduate of the College of William and Mary and he received his Masters Degree in Microbiology from Thomas Jefferson University in Philadelphia, PA. He then received his MD from St George’s University School of Medicine. He completed a residency in internal medicine at the Washington Hospital Center Georgetown University Internal Medicine Program in Washington, DC. After completing an infectious disease fellowship in NIAID at the National Institutes of Health, Dr. Memoli developed a clinical/translational research program to study influenza and other respiratory viruses in the Laboratory of Infectious Diseases. He now serves as the Chief of the LID Clinical Studies Unit.

Rani Athota, Susan Reed, Lindsay Czajkowski, Luz Angela Rosas, Adriana Cervantes-Medina, Alison Han, Rachel Bean, Holly Ann Baus, Jason Cleath, Kristina Edwards, Luca Giurgea, Dana Neitzey

Memoli MJ, Han A, Walters KA, Czajkowski L, Reed S, Athota R, Rosas LA, Cervantes-Medina A, Park JK, Morens DM, Kash JC, Taubenberger JK. Influenza A Reinfection in Sequential Human Challenge: Implications for Protective Immunity and "Universal" Vaccine Development. Clin Infect Dis. 2019 Apr 6. pii: ciz281. doi: 10.1093/cid/ciz281.

Han A, Czajkowski LM, Donaldson A, Baus HA, Reed SM, Athota RS, Bristol T, Rosas LA, Cervantes-Medina A, Taubenberger JK, Memoli MJ. A Dose Finding Study of a Wild-Type Influenza A/H3N2 virus in a Healthy Volunteer Human Challenge Model. Clin Infect Dis. 2019 Feb 16. pii: ciz141. doi: 10.1093/cid/ciz141.

Park JK, Han A, Czajkowski L, Reed S, Athota R, Bristol T, Rosas LA, Cervantes-Medina A, Taubenberger JK, Memoli MJ. Evaluation of Preexisting Anti-Hemagglutinin Stalk Antibody as a Correlate of Protection in a Healthy Volunteer Challenge with Influenza A/H1N1pdm Virus. MBio. 2018 Jan 23;9(1). pii: e02284-17. doi: 10.1128/mBio.02284-17.

Memoli MJ, Shaw PA, Han A, Czajkowski L, Reed S, Athota R, Bristol T, Fargis S, Risos K, Powers JH, Davey RT Jr, Taubenberger JK. Evaluation of Antihemagglutinin and Antineuraminidase Antibodies as Correlates of Protection in an Influenza A/H1N1 Virus Healthy Human Challenge Model. MBio. 2016 Apr 19;7(2):e00417-16. doi: 10.1128/mBio.00417-16.

Memoli MJ, Czajkowski L, Reed S, Athota R, Bristol T, Proudfoot K, Fargis S, Stein M, Dunfee RL, Shaw PA, Davey RT, Taubenberger JK. Validation of the wild-type influenza A human challenge model H1N1pdMIST: an A(H1N1)pdm09 dose-finding investigational new drug study. Clin Infect Dis. 2015 Mar 1;60(5):693-702. doi: 10.1093/cid/ciu924.

Memoli MJ, Athota R, Reed S, Czajkowski L, Bristol T, Proudfoot K, Hagey R, Voell J, Fiorentino C, Ademposi A, Shoham S, Taubenberger JK. The natural history of influenza infection in the severely immunocompromised vs nonimmunocompromised hosts. Clin Infect Dis. 2014 Jan;58(2):214-24. doi: 10.1093/cid/cit725.

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Screening Healthy Volunteers for Influenza Challenge Studies