作成日：令和４年４月７日 第１版〔ホームページ公開用資料〕

Quantifying monkeypox virus infection dynamics
１．Clinical researchinterdisciplinary Biology Laboratory, Division of Natural Science, Graduate Schoolof Science, Nagoya University, received data from monkeypox patients participating
in a clinical trial conducted by the United States Army Medical Research Instituteof Infectious Diseases (USAMRIID) in the Republic of Congo from 2007-2011. The
laboratory is using process-driven and data-driven approaches to quantify
heterogeneity in the duration of viral shedding, optimize the duration of isolationin light of this heterogeneity, and identify causal relationships between isolation
duration, clinical symptoms, and clinical outcomes. We are conducting research toclarify the causal relationship between isolation duration, clinical symptoms, andclinical outcomes. Permission to conduct this research has been granted by the headof the research institute after review by the Ethical Review Committee of the relevant
department of Nagoya University Higashiyama Campus. The period during which thisresearch is permitted is until 31, March 2024.
２．Purpose, significance and usefulness of the research
On July 23, 2022, the World Health Organization (WHO) declared "monkeypox" a publichealth emergency of international concern. We are currently conducting
interdisciplinary research combining drug repositioning (a method of finding a drug
effective for one disease from an existing drug effective for another disease) andsimulation, which has the potential to rapidly identify drugs with antiviral effects,
in order to identify drugs that are expected to be effective against the monkeypox
virus (MPXV). We have identified drugs that are expected to be effective against themonkeypox virus (MPXV). The simulations, which integrate pharmacokinetic (PK)information accumulated for each approved drug candidate, pharmacodynamic (PD)information obtained from viral infection experiments, and viral dynamics (VD)
information obtained from past clinical data, suggest that Atovacon is the mosteffective drug for patients with monkeypox. In this study, we stratified the shedding
patterns of MPXV-infected cases using data on viral shedding and other parameters,
and conducted a factor analysis to determine the pattern of viral shedding by linking
observation, examination, and assessment items for each case. We also aim to elucidate
the mechanisms involved in the prevention of MPXV infection and the development andseverity of the disease in MPXV-infected patients.

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３．Research subjects
The research will be conducted by the Human Use Committee of USAMRIID, theInstitutional Review Board (IRB) of the U.S. Army Medical Research and Development
Command, and the Ethics Committee of the University of Kinshasa School of Public Health(KSPH). Data obtained from "Clinical characterization of human monkeypox infectionsin the DRC (FY05-13)," which has been reviewed and approved by the U.S. Army Medical
Research and Development Command Institutional Review Board (IRB) and the Ethics
Committee of the University of Kinshasa School of Public Health (KSPH).
４．Methods of the study
Data received from USARMIID in a non-personally identifiable form will be stored
on an external hard disk with a password lock, kept on a locked shelf ininterdisciplinary Biology Laboratory, Division of Natural Science, Graduate Schoolof Science, Nagoya University, and not taken out of the laboratory. The data obtainedin this research will not be used for any purpose other than research purposes. Theacquired information will be analyzed using mathematical models and computer
simulations to quantitatively clarify the infection dynamics.
〔Information to be obtained〕
Clinical information (not including personal information), patient informationaccompanying specimens for testing, results of quantitative MPXV DNA testing ofblood, throat swabs, and crusts, and evaluation results using residual blood
specimens.
５．Handling of personal information
Data received from USARMIID in a non-personally identifiable form will be stored
on an external hard disk with a password lock and kept on a locked shelf ininterdisciplinary Biology Laboratory, Division of Natural Science, Graduate Schoolof Science, Nagoya University. The data will not be personal information since thecorrespondence list will not be provided, but the data will be handled with care.
Care will also be taken to ensure that the subjects are not identified in a small
number of cases, etc. Data obtained in this research will not be used for any purpose
other than for research purposes.
６．Ethical considerations
The subject of the research is free to withdraw consent or not, and will not suffer
any disadvantages. If the subject requests to withdraw consent, information obtainedon the subject in the course of the research will be immediately discarded. However,2作成日：令和４年４月７日 第１版〔ホームページ公開用資料〕

if the research results have already been published in a report or academic paper
at the time of withdrawal of consent, it may not be possible to remove the informationfrom the report or paper.
７．Storage of samples and information〔Regarding information〕
In principle, the clinical trial information, etc. on research subjects obtainedin this research will be used for this research, and after the research is completed,
it will be stored for 10 years under the responsibility of Shingo Iwami, Professor,Department of Science, Graduate School of Science, Nagoya University, after which
the research numbers, etc. will be deleted and destroyed. After 10 years, the researchnumbers, etc. will be deleted and discarded.
The information on research subjects obtained in this study may also be very valuablefor other medical research planned and conducted in the future. Therefore, we would
like to keep the information beyond the aforementioned period and use it for new
medical research to be planned and conducted in the future. If such research is tobe conducted, it will be done only after the research plan has been reviewed andapproved by the Ethics Review Committee.
８．Publication of Research Results
The results of the research will be made public through presentations at academic
conferences, publication of articles, and release in databases.
９．Disclosure of research and personal information
We will make available the research protocol and materials related to the researchmethodology to the extent that it does not interfere with the protection of thepersonal information of the participants in this research or with ensuring theoriginality of this research. Please contact us if you wish to view these materials.
１０．Research Implementation StructureThis research will be conducted under the following structure.
ResearchLocation(Field, etc.)
ResearchDirector
Research

interdisciplinary Biology Laboratory (iBLab):
Division of Natural Science, Graduate School of Science, Nagoya
University, Japan
Shingo Iwami, Professor, Division of Natural Science, Graduate
School of Science, Nagoya University
None3作成日：令和４年４月７日 第１版〔ホームページ公開用資料〕

Assignee
１１．Consultation Service
If you have any questions or concerns about this research (e.g., withdrawal ofconsent or refusal to use data), please contact the secretariat.
Secretariat

Contact person: Professor Shingo Iwami, Division of NaturalScience, Graduate School of Science, Nagoya University
Contact: [TEL] 052-789-2992 (ext. 2992)
E-mail address: iwami.iblab@bio.nagoya-u.ac.jp

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