Early Phase Clinical Trial Units (EPCTU)

The National Institute of Allergy and Infectious Diseases (NIAID) awarded the Early Phase Clinical Trial Units (EPCTU) Master IDIQ on January 14, 2022, to conduct Phase 0 through Phase II clinical trials, including proof-of-concept studies in healthy and diseased human populations domestically and internationally, with bioanalysis support where necessary and occasional Phase III studies in urgent public health circumstances. Ordering authority extends through January 13, 2032, providing approximately 5 years and 5 months of remaining procurement window.

The vehicle carries a combined potential value of $21.9 million across 10 task orders, with $16.9 million obligated to date (77% of ceiling). Ordering momentum has decelerated sharply: 6 orders were placed in 2022, 3 in 2023, and only 1 in 2024, the most recent award dated August 15, 2024. Task-order ceilings range from approximately $1.5 million to $3.2 million, with Cost Plus Fixed Fee and Cost No Fee pricing structures. Four orders carry extended completion dates extending to January 13, 2032 (vehicle expiration), while others conclude between 2025 and 2028.

Five distinct prime contractors share the workload with no concentration risk. Icon Government And Public Health Solutions, Inc. holds 3 orders totaling $6.2 million; Allucent Government Services (US) LLC, PPD Development LP, and Dynport Vaccine Company LLC each hold 2 orders, with combined potential values of $4.7 million, $4.7 million, and $4.5 million respectively; Duke University holds 1 order for $2 million. All 10 task orders fund NIAID directly with no diversification across customer agencies.

The vehicle uses no set-asides; all task orders are unrestricted competitive awards. Recent work spans specific Phase I healthy volunteer studies, Phase I special population studies, and clinical evaluation of novel immunomodulatory products, including a Phase 1 trial of a genetically modified probiotic yeast for Clostridioides difficile.

Implement Phase 0 to Phase II clinical trials, including proof-of-concept studies in healthy and diseased human populations-domestically and internationally-in an expeditious and efficient manner, aided by bioanalysis when necessary. Additionally, in the event of urgent public health need, Phase III studies may be conducted. The candidate products to be evaluated under the Early Phase Clinical Trial Units (EPCTU) IDIQ contracts could include new or tested investigational products, such as small molecules; monoclonal antibodies; immunoglobulins; convalescent plasma; passive transfer studies; vaccines; adjuvants; and other immunomodulatory products against infectious diseases, arising within DMID's preclinical and early product development programs, as well as those arising from other research partners outside of DMID.