Clinical and Biostatistics Core

Project Summary/Abstract – Clinical and Biostatistics Core
The Clinical and Biostatistics Core (CBC) is a central component of the Evaluating Modes of Influenza
Transmission (EMIT-2) program. The overall objective of this core is to perform a series of randomized clinical
studies of influenza transmission to comprehensively evaluate viral, host, physical, and environmental factors
that facilitate efficient human-to-human influenza transmission. In these studies, healthy participants who have
no or very low levels of hemagglutination inhibiting antibodies to the current year’s vaccine strains will spend
up to four days in contact with participants naturally infected with influenza virus and recruited by Research
Project 1 (RP1). Each study in the series will employ an environmental intervention and a personal protection
intervention designed by Research Project 2 (RP2). The core will provide the platform for collection of clinical
and environmental samples by each of the two projects and the Advanced Bioaerosol Technology Core
(ABTC). The clinical research facility for this project, Pharmaron Baltimore, has a long history of collaboration
with the University of Maryland Center for Vaccine Development and is a site for the NIAID CIVIC program.
The goals of this core will be achieved through the following specific aims: (1) Provide regulatory and safety
infrastructure for a randomized controlled trial of influenza transmission; (2) Screen for healthy adult volunteers
(Recipients), willing to temporarily reside on an inpatient containment unit approximately 2 weeks during the
influenza season, and index cases with acute influenza infection (Donors); and (3) Expose un-infected eligible
volunteers to influenza-infected index case patients. An independent Data and Safety Monitoring Board will be
assembled to provide safety oversight over the conduct of the transmission studies. Ultimate oversight of the
CBC’s activity will be the responsibility of the Core Leader (Dr. Chen) and Co-Investigator (Dr. Ortiz) and will
include close coordination with the Projects and Cores of this U19.

Grant Number: 5U19AI162130-05
NIH Institute/Center: NIH
Principal Investigator: Wilbur Chen