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  1. Article ; Online: Infectious disease experimentation involving human volunteers.

    Rosenbaum, Julie Rothstein / Sepkowitz, Kent A

    Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

    2002  Volume 34, Issue 7, Page(s) 963–971

    Abstract: ... of healthy volunteers in human-subject research in infectious diseases to determine the contributions ... The current care of patients with infectious diseases owes a tremendous debt to healthy volunteers ... successfully induced infection through injecting, nebulizing, and feeding specimens to thousands of volunteers ...

    Abstract The current care of patients with infectious diseases owes a tremendous debt to healthy volunteers who allowed investigators to induce disease in them for the study of transmission, natural history, and treatment. We reviewed the English-language medical literature about the rarely discussed subject of the use of healthy volunteers in human-subject research in infectious diseases to determine the contributions of these experiments to the current understanding of disease transmission. The literature review focused on hepatitis, upper respiratory infections, and malaria, which represent the array of issues involved in this type of research. Researchers successfully induced infection through injecting, nebulizing, and feeding specimens to thousands of volunteers, who included authentic volunteers as well as soldiers and imprisoned subjects. These volunteers often undertook unforeseen and unpredictable risks during these experiments for the benefit of others. Future research in these areas must strike an adequate balance between the risks to participants and the benefits to society.
    MeSH term(s) Communicable Diseases ; Ethics, Medical ; Healthy Volunteers ; Hepatitis ; Human Experimentation/ethics ; Humans ; Malaria ; Research Design ; Respiratory Tract Infections ; Risk Assessment
    Language English
    Publishing date 2002-04-01
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 1099781-7
    ISSN 1537-6591 ; 1058-4838
    ISSN (online) 1537-6591
    ISSN 1058-4838
    DOI 10.1086/339328
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: What risks should be permissible in controlled human infection model studies?

    Binik, Ariella

    Bioethics

    2020  Volume 34, Issue 4, Page(s) 420–430

    Abstract: Controlled human infection model (CHIM) studies involve the intentional exposure of healthy ... research volunteers to infectious agents. These studies contribute to knowledge about the cause or ... development of disease and to the advancement of vaccine research. But they also raise ethical questions ...

    Abstract Controlled human infection model (CHIM) studies involve the intentional exposure of healthy research volunteers to infectious agents. These studies contribute to knowledge about the cause or development of disease and to the advancement of vaccine research. But they also raise ethical questions about the kinds of risks that should be permissible and whether limits should be imposed on research risks in CHIM studies. Two possible risk thresholds have been considered for CHIM studies. The first suggests constraining ethically permissible risks according to a minimal risk threshold and the second endorses a higher risk threshold that excludes irreversible or fatal infections. I argue that neither of these thresholds is persuasive and situate questions about risk thresholds in CHIM studies within a broader debate about permissible risks in research. I argue that risks in CHIM studies should be constrained according to limits on research risks that do not offer corresponding benefits in all studies rather than developing a unique risk threshold for CHIM studies. I then propose five recommendations for the ethical assessment of risk in CHIM studies.
    MeSH term(s) Biomedical Research/ethics ; Communicable Diseases/pathology ; Ethics, Research ; Human Experimentation/ethics ; Humans ; Research Design ; Research Subjects ; Risk Assessment
    Language English
    Publishing date 2020-03-01
    Publishing country England
    Document type Journal Article
    ZDB-ID 632984-6
    ISSN 1467-8519 ; 0269-9702
    ISSN (online) 1467-8519
    ISSN 0269-9702
    DOI 10.1111/bioe.12736
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Identification of Haemophilus ducreyi genes expressed during human infection.

    Bauer, Margaret E / Fortney, Kate R / Harrison, Alistair / Janowicz, Diane M / Munson, Robert S / Spinola, Stanley M

    Microbiology (Reading, England)

    2008  Volume 154, Issue Pt 4, Page(s) 1152–1160

    Abstract: To identify Haemophilus ducreyi transcripts that are expressed during human infection, we used ... volunteers infected with H. ducreyi, and with RNA isolated from broth-grown bacteria used to infect ... volunteers. With SCOTS, competitive hybridization of tissue-derived and broth-derived sequences identifies ...

    Abstract To identify Haemophilus ducreyi transcripts that are expressed during human infection, we used selective capture of transcribed sequences (SCOTS) with RNA isolated from pustules obtained from three volunteers infected with H. ducreyi, and with RNA isolated from broth-grown bacteria used to infect volunteers. With SCOTS, competitive hybridization of tissue-derived and broth-derived sequences identifies genes that may be preferentially expressed in vivo. Among the three tissue specimens, we identified 531 genes expressed in vivo. Southern blot analysis of 60 genes from each tissue showed that 87 % of the identified genes hybridized better with cDNA derived from tissue specimens than with cDNA derived from broth-grown bacteria. RT-PCR on nine additional pustules confirmed in vivo expression of 10 of 11 selected genes in other volunteers. Of the 531 genes, 139 were identified in at least two volunteers. These 139 genes fell into several functional categories, including biosynthesis and metabolism, regulation, and cellular processes, such as transcription, translation, cell division, DNA replication and repair, and transport. Detection of genes involved in anaerobic and aerobic respiration indicated that H. ducreyi likely encounters both microenvironments within the pustule. Other genes detected suggest an increase in DNA damage and stress in vivo. Genes involved in virulence in other bacterial pathogens and 32 genes encoding hypothetical proteins were identified, and may represent novel virulence factors. We identified three genes, lspA1, lspA2 and tadA, known to be required for virulence in humans. This is the first study to broadly define transcripts expressed by H. ducreyi in humans.
    MeSH term(s) Female ; Gene Expression Profiling ; Genes, Bacterial ; Haemophilus ducreyi/genetics ; Haemophilus ducreyi/isolation & purification ; Human Experimentation ; Humans ; Male ; Skin Diseases, Bacterial/microbiology
    Language English
    Publishing date 2008-03-28
    Publishing country England
    Document type Comparative Study ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 1180712-x
    ISSN 1465-2080 ; 1350-0872
    ISSN (online) 1465-2080
    ISSN 1350-0872
    DOI 10.1099/mic.0.2007/013953-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Using the Influenza Patient-reported Outcome (FLU-PRO) diary to evaluate symptoms of influenza viral infection in a healthy human challenge model.

    Han, Alison / Poon, Jiat-Ling / Powers, John H / Leidy, Nancy K / Yu, Ren / Memoli, Matthew J

    BMC infectious diseases

    2018  Volume 18, Issue 1, Page(s) 353

    Abstract: Background: In clinical studies involving a healthy volunteer human challenge model, a valid and ... from influenza infection in clinical research. In this human challenge study, scores were responsive to change ... diary as a standardized measure of symptom severity in a healthy volunteer human challenge model ...

    Abstract Background: In clinical studies involving a healthy volunteer human challenge model, a valid and reliable measure to assess the evolution of patient-reported symptom type and severity following viral exposure is necessary. This study examines the use of the InFLUenza Patient-Reported Outcome (FLU-PRO) diary as a standardized measure of symptom severity in a healthy volunteer human challenge model.
    Methods: Healthy adults admitted to the NIH Clinical Center (Day - 1) underwent a 9-day inpatient quarantine after intranasal challenge with a wild-type influenza A/H1N1pdm virus (Day 0). Participants completed the 32-item FLU-PRO diary twice daily for 14 days to assess presence, severity, and duration of symptoms across six body systems. Secondary analyses included descriptive statistics to examine FLU-PRO scores over the course of illness and analysis of variance to compare scores on Day 3 post-challenge by presence of viral shedding, and pre-challenge hemagglutinin and neuraminidase inhibition (HAI and NAI) titers.
    Results: All but one subject (99%), who was lost to follow-up, completed twice daily FLU-PRO diaries on all study assessment days. FLU-PRO demonstrated that 61 of 65 subjects reported symptoms (Days: Median 5, Mean 6 ± 7), of whom 37 (61%) had viral shedding. Pre-challenge, 39 (64%) and 10 (16%) subjects had low (< 1:40) HAI and NAI titers, respectively. Nose, throat, body, and gastrointestinal (GI) symptoms reached peak intensity at Day 3, followed by chest/respiratory and eye symptoms at Day 4. Subjects with viral shedding had higher mean FLU-PRO scores compared to those without, except for Eye and GI domains (p <0.05). Mean FLU-PRO scores were significantly higher for subjects with low NAI titer (p <0.05) across all domains. No significant differences were observed between HAI titer groups. FLU-PRO scores of the low HAI-low NAI group (n = 10) were significantly higher (more severe) than the other two groups (p < 0.05) (high HAI-high NAI (n = 22), low HAI-high NAI (n = 29)).
    Conclusions: The FLU-PRO had high adherence and low respondent burden. It can be used to track symptom onset, intensity, duration, and recovery from influenza infection in clinical research. In this human challenge study, scores were responsive to change and distinguished known clinical subgroups.
    Trial registration: NCT01971255 First Registered October 2, 2013.
    MeSH term(s) Adolescent ; Adult ; Female ; Healthy Volunteers ; Human Experimentation ; Humans ; Influenza A virus/physiology ; Influenza, Human/diagnosis ; Influenza, Human/pathology ; Influenza, Human/virology ; Male ; Medical Records ; Models, Biological ; Orthomyxoviridae/physiology ; Patient Reported Outcome Measures ; Surveys and Questionnaires ; Virus Shedding ; Young Adult
    Language English
    Publishing date 2018-07-28
    Publishing country England
    Document type Journal Article
    ZDB-ID 2041550-3
    ISSN 1471-2334 ; 1471-2334
    ISSN (online) 1471-2334
    ISSN 1471-2334
    DOI 10.1186/s12879-018-3220-8
    Database MEDical Literature Analysis and Retrieval System OnLINE

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