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. 2025 Jul 23;20(7):e0317065.
doi: 10.1371/journal.pone.0317065. eCollection 2025.

The infectious diseases clinical research program acute respiratory infection repository protocol: Opportunities to understand current and future epidemics

Simon D Pollett  1   2 , Rhonda E Colombo  1   2   3   4 , Stephanie A Richard  1   2 , Tahaniyat Lalani  1   2   5 , Brianne Barton  1   2 , Allison Malloy  6 , Anthony Fries  7 , Edward Parmelee  1   2 , Scott Merritt  1   2 , Mark Fritschlanski  1   2 , Edward E Mitre  8 , Eric D Laing  8 , Kathleen Pratt  9 , Eric C Garges  1 , Katrin Mende  1   2   10 , Mark Simons  1 , Brian Agan  1   2 , David Tribble  1 , Robert O'Connell  1 , Timothy H Burgess  1
Affiliations

The infectious diseases clinical research program acute respiratory infection repository protocol: Opportunities to understand current and future epidemics

Simon D Pollett et al. PLoS One. .

Abstract

Background: Acute respiratory infections (ARI) are a major cause of morbidity and lost workdays in both military and non-military populations. To better understand these infections and their outcomes, the Infectious Diseases Clinical Research Program has enabled nine major ARI clinical research protocols in the last decade, including observational studies and trials, spanning emerging and reemerging ARI threats including Severe Acute Respiratory Syndrome Coronavirus 2, influenza, adenovirus, entero/rhinovirus, human metapneumovirus, respiratory syncytial virus, and other pathogens. These protocols have resulted in epidemiological, clinical and laboratory data and biospecimens from over 26,000 participants, most of whom were beneficiaries of a geographically distributed Military Health System.

Methods: The Acute Respiratory Infection Repository Protocol establishes a unique Department of Defense (DoD) research resource through the pooling of data and specimens from nine ARI protocols into a master, standardized database with a linked specimen repository. This will enable further targeted scientific questions in participant-level pooled meta-analyses and will serve as an on-demand repository for rapid assay development, sample size estimations for prospective studies, and observational study/clinical trial design (including as part of future rapid pandemic research response). Accordingly, the objectives and study design of this protocol are broad. This protocol will allow analyses on outcomes including: (i) short-term ARI outcomes such as hospitalization, work days lost, symptom severity and duration; (ii) post-acute ARI outcomes, including persistence of symptoms, return-to-health, post-ARI medical encounters; (iii) vaccine effectiveness for Coronavirus disease 2019 (COVID-19), influenza, and adenovirus vaccines; (iv) ARI infection and vaccination elicited immune responses (humoral, T-cell, other); (v) therapeutic effectiveness of COVID-19 and influenza antivirals (acute symptoms, hospitalization, post-acute sequelae); (vi) effectiveness of non-pharmaceutical interventions (e.g., masking) against infection; (vii) prognostic and mechanistic host viral biomarkers which correlate with the above outcomes; (viii) ARI diagnostic assay validity and performance. This repository protocol is inherently broad in scope; the collation of standardized data and phenotype-linked specimens is a fundamental, primary objective.

Discussion: This protocol will support statistical and laboratory analyses, including activities related to rapid epidemic response such as assay development and rapid sample size calculations for clinical trials. A series of more specific scientific questions from current and future collaborators will leverage this joint database and specimen repository; these questions will target important aspects of ARI infection, transmission, outcomes, and treatment. Future protocols (and ongoing data from existing IDCRP protocols) will be added to this collaborative repository protocol.

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Conflict of interest statement

Potential conflicts of interest. S. D. P., T. H. B., D.R.T, and M.P.S. report that the Uniformed Services University (USU) Infectious Diseases Clinical Research Program (IDCRP), a US Department of Defense institution, and the Henry M. Jackson Foundation (HJF) were funded under a Cooperative Research and Development Agreement to conduct an unrelated phase III COVID-19 monoclonal antibody immunoprophylaxis trial sponsored by AstraZeneca. The HJF, in support of the USU IDCRP, was funded by the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense to augment the conduct of an unrelated phase III vaccine trial sponsored by AstraZeneca. Both of these trials were part of the US Government COVID-19 response. Neither is related to the work presented here.

Figures

Fig 1
Fig 1. Schema showing the approach to data and specimen curation.
Protocols A, B, and C are notional illustrative protocols.
See this image and copyright information in PMC

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References

    1. Sanchez JL, Cooper MJ, Myers CA, Cummings JF, Vest KG, Russell KL, et al. Respiratory Infections in the U.S. Military: Recent Experience and Control. Clin Microbiol Rev. 2015;28(3):743–800. doi: 10.1128/CMR.00039-14 - DOI - PMC - PubMed
    1. Gray GC, Callahan JD, Hawksworth AW, Fisher CA, Gaydos JC. Respiratory diseases among U.S. military personnel: countering emerging threats. Emerg Infect Dis. 1999;5(3):379–85. doi: 10.3201/eid0503.990308 - DOI - PMC - PubMed
    1. O’Shea MK, Wilson D. Respiratory infections in the military. J R Army Med Corps. 2013;159(3):181–9. doi: 10.1136/jramc-2013-000110 - DOI - PubMed
    1. Russell KL, Hawksworth AW, Ryan MAK, Strickler J, Irvine M, Hansen CJ, et al. Vaccine-preventable adenoviral respiratory illness in US military recruits, 1999-2004. Vaccine. 2006;24(15):2835–42. doi: 10.1016/j.vaccine.2005.12.062 - DOI - PMC - PubMed
    1. Kolavic-Gray SA, Binn LN, Sanchez JL, Cersovsky SB, Polyak CS, Mitchell-Raymundo F, et al. Large epidemic of adenovirus type 4 infection among military trainees: epidemiological, clinical, and laboratory studies. Clin Infect Dis. 2002;35(7):808–18. doi: 10.1086/342573 - DOI - PubMed

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