دورية أكاديمية
Beyond Blood Smears: Qualification of Plasmodium 18S rRNA as a Biomarker for Controlled Human Malaria Infections.
| العنوان: | Beyond Blood Smears: Qualification of Plasmodium 18S rRNA as a Biomarker for Controlled Human Malaria Infections. |
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| المؤلفون: | Seilie AM; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Chang M; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Hanron AE; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Billman ZP; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Stone BC; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Zhou K; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Olsen TM; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Daza G; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Ortega J; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Cruz KR; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Smith N; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Healy SA; Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.; Division of Pediatric Infectious Diseases, Department of Pediatrics, University of Washington, Seattle, Washington.; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington., Neal J; Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland., Wallis CK; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington., Shelton L; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington., Mankowski TV; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington., Wong-Madden S; Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland., Mikolajczak SA; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington., Vaughan AM; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington., Kappe SHI; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington., Fishbaugher M; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington., Betz W; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington., Kennedy M; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington., Hume JCC; Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland., Talley AK; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington., Hoffman SL; Sanaria, Inc., Rockville, Maryland., Chakravarty S; Sanaria, Inc., Rockville, Maryland., Sim BKL; Sanaria, Inc., Rockville, Maryland., Richie TL; Sanaria, Inc., Rockville, Maryland., Wald A; Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington., Plowe CV; Duke Global Health Institute, Duke University, Durham, North Carolina., Lyke KE; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland., Adams M; Center for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland., Fahle GA; Microbiology Service, Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland., Cowan EP; Partners in Diagnostics, Rockville, Maryland., Duffy PE; Laboratory of Malaria Immunology and Vaccinology, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland., Kublin JG; Seattle Malaria Clinical Trials Center, Fred Hutch Cancer Research Center, Seattle, Washington.; Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, Washington., Murphy SC; Department of Microbiology, University of Washington, Seattle, Washington.; Seattle Malaria Clinical Trials Center, Fred Hutch Cancer Research Center, Seattle, Washington.; Center for Global Infectious Disease Research, Seattle Children's Research Institute (formerly the Center for Infectious Disease Research), Seattle, Washington.; Department of Laboratory Medicine, Center for Emerging and Re-emerging Infectious Diseases, University of Washington, Seattle, Washington. |
| المصدر: | The American journal of tropical medicine and hygiene [Am J Trop Med Hyg] 2019 Jun; Vol. 100 (6), pp. 1466-1476. |
| نوع المنشور: | Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Validation Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: American Society of Tropical Medicine and Hygiene Country of Publication: United States NLM ID: 0370507 Publication Model: Print Cited Medium: Internet ISSN: 1476-1645 (Electronic) Linking ISSN: 00029637 NLM ISO Abbreviation: Am J Trop Med Hyg Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Northbrook, IL : American Society of Tropical Medicine and Hygiene Original Publication: Baltimore. |
| مواضيع طبية MeSH: | Malaria/*diagnosis , Plasmodium/*genetics , RNA, Protozoan/*genetics , RNA, Ribosomal, 18S/*blood, Biomarkers/blood ; Humans ; Multiplex Polymerase Chain Reaction ; Plasmodium/isolation & purification ; RNA, Ribosomal, 18S/genetics ; Real-Time Polymerase Chain Reaction ; Reproducibility of Results ; Reverse Transcriptase Polymerase Chain Reaction |
| مستخلص: | 18S rRNA is a biomarker that provides an alternative to thick blood smears in controlled human malaria infection (CHMI) trials. We reviewed data from CHMI trials at non-endemic sites that used blood smears and Plasmodium 18S rRNA/rDNA biomarker nucleic acid tests (NATs) for time to positivity. We validated a multiplex quantitative reverse transcription-polymerase chain reaction (qRT-PCR) for Plasmodium 18S rRNA, prospectively compared blood smears and qRT-PCR for three trials, and modeled treatment effects at different biomarker-defined parasite densities to assess the impact on infection detection, symptom reduction, and measured intervention efficacy. Literature review demonstrated accelerated NAT-based infection detection compared with blood smears (mean acceleration: 3.2-3.6 days). For prospectively tested trials, the validated Plasmodium 18S rRNA qRT-PCR positivity was earlier (7.6 days; 95% CI: 7.1-8.1 days) than blood smears (11.0 days; 95% CI: 10.3-11.8 days) and significantly preceded the onset of grade 2 malaria-related symptoms (12.2 days; 95% CI: 10.6-13.3 days). Discrepant analysis showed that the risk of a blood smear-positive, biomarker-negative result was negligible. Data modeling predicted that treatment triggered by specific biomarker-defined thresholds can differentiate complete, partial, and non-protective outcomes and eliminate many grade 2 and most grade 3 malaria-related symptoms post-CHMI. Plasmodium 18S rRNA is a sensitive and specific biomarker that can justifiably replace blood smears for infection detection in CHMI trials in non-endemic settings. This study led to biomarker qualification through the U.S. Food and Drug Administration for use in CHMI studies at non-endemic sites, which will facilitate biomarker use for the qualified context of use in drug and vaccine trials. |
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| معلومات مُعتمدة: | P30 AI027757 United States AI NIAID NIH HHS; U01 AI109700 United States AI NIAID NIH HHS |
| المشرفين على المادة: | 0 (Biomarkers) 0 (RNA, Protozoan) 0 (RNA, Ribosomal, 18S) |
| تواريخ الأحداث: | Date Created: 20190425 Date Completed: 20200123 Latest Revision: 20210109 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC6553913 |
| DOI: | 10.4269/ajtmh.19-0094 |
| PMID: | 31017084 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1476-1645 |
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| DOI: | 10.4269/ajtmh.19-0094 |