Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.
Gespeichert in:
| Titel: | Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network. |
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| Autoren: | Atmar RL; Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, Texas, USA., Abate G; Center for Vaccine Development, Saint Louis University, St. Louis, Missouri, USA., Deming ME; Center for Vaccine Development and Global Health, The University of Maryland School of Medicine, Baltimore, Maryland, USA., George SL; Center for Vaccine Development, Saint Louis University, St. Louis, Missouri, USA.; Department of Internal Medicine, Saint Louis VA Medical Center, St. Louis, Missouri, USA., Fleming A; NYU Langone Vaccine Center and Division of Infectious Diseases and Immunology, Department of Medicine, NYU Grossman School of Medicine, New York, New York, USA., Frey SE; Center for Vaccine Development, Saint Louis University, St. Louis, Missouri, USA., Lyke KE; Center for Vaccine Development and Global Health, The University of Maryland School of Medicine, Baltimore, Maryland, USA., Stephens DS; Woodruff Health Sciences Center, Atlanta, Georgia, USA.; Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA., Del Rio C; Department of Medicine, Emory University School of Medicine, Atlanta, Georgia, USA., El Sahly HM; Departments of Molecular Virology & Microbiology and Medicine, Baylor College of Medicine, Houston, Texas, USA. |
| Quelle: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2025 Oct 10; Vol. 81 (Supplement_2), pp. S89-S102. |
| Publikationsart: | Journal Article; Review |
| Sprache: | English |
| Info zur Zeitschrift: | Publisher: Oxford University Press Country of Publication: United States NLM ID: 9203213 Publication Model: Print Cited Medium: Internet ISSN: 1537-6591 (Electronic) Linking ISSN: 10584838 NLM ISO Abbreviation: Clin Infect Dis Subsets: MEDLINE |
| Imprint Name(s): | Publication: Jan. 2011- : Oxford : Oxford University Press Original Publication: Chicago, IL : The University of Chicago Press, c1992- |
| MeSH-Schlagworte: | Pandemics*/prevention & control , Communicable Diseases, Emerging*/prevention & control , Communicable Diseases, Emerging*/epidemiology, Humans ; COVID-19/prevention & control ; Biomedical Research ; United States ; Clinical Trials as Topic ; SARS-CoV-2 ; COVID-19 Vaccines ; Vaccines/immunology ; National Institute of Allergy and Infectious Diseases (U.S.) |
| Abstract: | Competing Interests: Potential conflicts of interest. R. L. A. has received grant support from and served as a consultant to Hillevax, Inc. K. E. L. and S. L. G. have received grant awards from Pfizer Inc. and Sanofi (exclusive of the current work). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed. Pathogens infecting humans continue to emerge or reemerge to cause outbreaks and widespread disease. The National Institute of Allergy and Infectious Diseases has funded Vaccine Treatment and Evaluation Units (VTEUs) for more than 50 years. VTEUs perform clinical studies to assess the safety and immunogenicity of candidate vaccines and other interventions to mitigate the impact of emerging and ongoing infectious diseases. Here, we review clinical studies conducted in the VTEUs since 2000 that have addressed emerging pathogens and other infectious agents with pandemic potential or of bioterrorism concern. The studies conducted range from phase 1 to phase 3 clinical trials, and they have included vaccines, therapeutics, and epidemiological studies. The results of the trials have guided national and often international recommendations for treatment and prevention of many of the evaluated pathogens, culminating in coronavirus disease 2019 studies that began within three months of severe acute respiratory syndrome coronavirus 2 identification. The VTEU network continues to be a critical public health resource for addressing emerging pathogens and expediting the development of safe and effective vaccines and treatments to protect at-risk populations. (© The Author(s) 2025. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.) |
| References: | N Engl J Med. 2021 Oct 21;385(17):1627-1629. (PMID: 34525276) Clin Infect Dis. 2006 Nov 1;43(9):1135-42. (PMID: 17029131) Vaccine. 2015 Sep 22;33(39):5225-34. (PMID: 26143613) J Infect Dis. 2008 Mar 1;197(5):667-75. (PMID: 18260764) Lancet. 1998 Feb 14;351(9101):467-71. (PMID: 9482437) Milbank Q. 2004;82(3):413-55, table of contents. (PMID: 15330972) Lancet Microbe. 2025 Apr;6(4):100984. (PMID: 39884302) Vaccine. 2019 May 1;37(19):2561-2568. (PMID: 30955980) Immunity. 2005 Aug;23(2):165-75. (PMID: 16111635) JAMA. 2014 Oct 8;312(14):1409-19. (PMID: 25291577) J Infect Dis. 2004 Feb 1;189(3):493-7. (PMID: 14745707) PLoS One. 2011;6(8):e23699. (PMID: 21887300) JCI Insight. 2016 Jul 7;1(10):. (PMID: 27482543) Vaccines (Basel). 2020 Mar 13;8(1):. (PMID: 32183105) Lancet Respir Med. 2023 Nov;11(11):975-990. (PMID: 37716365) JAMA. 2002 May 1;287(17):2236-52. (PMID: 11980524) N Engl J Med. 2019 Nov 21;381(21):2009-2019. (PMID: 31693803) RNA Biol. 2024 Jan;21(1):1-27. (PMID: 38528828) Clin Infect Dis. 2023 Jan 05;:. (PMID: 36610741) N Engl J Med. 2021 Jun 10;384(23):2187-2201. (PMID: 33882225) Proteomics. 2017 Jun;17(12):. (PMID: 28508465) Viruses. 2019 Jul 04;11(7):. (PMID: 31277410) Pediatr Infect Dis J. 2014 Aug;33(8):865-71. (PMID: 25222307) Open Forum Infect Dis. 2022 Apr 27;9(7):ofac219. (PMID: 35818363) Vaccine. 2024 Jan 12;42(2):295-309. (PMID: 38105137) Antimicrob Agents Chemother. 2021 Jun 17;65(7):e0232920. (PMID: 33875433) NPJ Vaccines. 2024 Dec 23;9(1):255. (PMID: 39715748) Nature. 2020 Oct;586(7830):567-571. (PMID: 32756549) Cell. 2024 Sep 19;187(19):5171-5194. (PMID: 39303685) Vaccine. 2016 Jan 20;34(4):547-554. (PMID: 26657997) BMC Res Notes. 2013 May 03;6:177. (PMID: 23641940) J Control Release. 2024 Jun;370:516-527. (PMID: 38718875) N Engl J Med. 2020 Nov 12;383(20):1920-1931. (PMID: 32663912) J Infect Dis. 2024 Feb 14;229(2):327-340. (PMID: 37466221) JAMA Netw Open. 2023 Jan 3;6(1):e2251974. (PMID: 36689221) J Infect Dis. 1977 Jan;135(1):55-60. (PMID: 833449) Open Forum Infect Dis. 2014 Nov 18;1(3):ofu102. (PMID: 25734170) MMWR Morb Mortal Wkly Rep. 2023 Nov 03;72(44):1190-1196. (PMID: 37917561) Lancet Respir Med. 2021 Dec;9(12):1365-1376. (PMID: 34672949) PLoS One. 2013;8(1):e54407. (PMID: 23349878) Vaccine. 2017 Aug 24;35(36):4730-4737. (PMID: 28750854) J Infect Dis. 2023 Aug 11;228(3):287-298. (PMID: 36702771) Virology. 1999 Aug 15;261(1):15-9. (PMID: 10484749) JAMA. 2015 Jul 21;314(3):237-46. (PMID: 26197184) Lancet Haematol. 2022 Jan;9(1):e73-e80. (PMID: 34774202) Emerg Infect Dis. 2002 Feb;8(2):225-30. (PMID: 11897082) Cell Rep Med. 2022 Jul 19;3(7):100679. (PMID: 35798000) J Infect Dis. 2024 Sep 23;230(3):716-725. (PMID: 38181048) Vaccine. 2014 Oct 29;32(47):6284-93. (PMID: 25239484) J Infect Dis. 2019 Jun 5;220(1):46-56. (PMID: 30796818) EClinicalMedicine. 2024 Feb 09;69:102472. (PMID: 38361992) Vaccine. 2009 Aug 6;27(36):4905-11. (PMID: 19567246) Virology. 1996 Jun 1;220(1):223-6. (PMID: 8659118) Vaccine. 2023 Aug 14;41(36):5296-5303. (PMID: 37451878) J Infect Dis. 2015 Oct 1;212(7):1032-41. (PMID: 25791116) Vaccine. 2015 Jan 1;33(1):163-73. (PMID: 25444805) Clin Infect Dis. 2023 Feb 18;76(4):753-759. (PMID: 36131321) Clin Vaccine Immunol. 2015 Nov 11;23(1):73-7. (PMID: 26561390) Vaccine. 2009 Aug 13;27(37):5091-5. (PMID: 19577636) PLoS One. 2013;8(3):e59776. (PMID: 23527266) J Infect Dis. 2009 Mar 15;199(6):847-57. (PMID: 19239338) Vaccine. 2012 Jun 13;30(28):4240-8. (PMID: 22537984) J Infect Dis. 2004 Oct 1;190(7):1286-94. (PMID: 15346340) J Infect Dis. 2024 Jan 12;229(1):30-38. (PMID: 37380156) PLoS One. 2017 Jan 18;12(1):e0167488. (PMID: 28099485) Lancet. 2018 Feb 10;391(10120):563-571. (PMID: 29217375) J Infect Dis. 2011 Mar 1;203(5):666-73. (PMID: 21282194) Science. 1993 Nov 5;262(5135):914-7. (PMID: 8235615) N Engl J Med. 2022 Jul 7;387(1):58-65. (PMID: 35767527) Vaccine. 2001 Feb 8;19(13-14):1732-7. (PMID: 11166898) N Engl J Med. 2022 Mar 17;386(11):1088-1091. (PMID: 35081298) N Engl J Med. 2022 Mar 17;386(11):1046-1057. (PMID: 35081293) BMC Pregnancy Childbirth. 2022 May 12;22(1):402. (PMID: 35550037) Nature. 2020 Oct;586(7830):589-593. (PMID: 32785213) Vaccine. 2014 May 13;32(23):2732-9. (PMID: 24607004) Emerg Infect Dis. 2006 Jan;12(1):15-22. (PMID: 16494711) N Engl J Med. 2021 Nov 4;385(19):1761-1773. (PMID: 34525277) J Infect Dis. 2008 Sep 1;198(5):635-41. (PMID: 18694338) Vaccine. 2019 Jul 9;37(30):4222-4230. (PMID: 30661836) Vaccine. 2017 Mar 23;35(13):1675-1682. (PMID: 28256358) Vaccine. 2009 Nov 5;27(47):6642-8. (PMID: 19773098) J Infect Dis. 2012 Sep 15;206(6):811-20. (PMID: 22782949) Nat Med. 2020 Feb;26(2):228-235. (PMID: 32015557) J Infect Dis. 2019 May 5;219(11):1786-1798. (PMID: 30566602) Sci Transl Med. 2010 Jan 20;2(15):15ra5. (PMID: 20371470) Clin Infect Dis. 2023 Jan 05;:. (PMID: 36610728) N Engl J Med. 2002 Apr 25;346(17):1265-74. (PMID: 11923490) Hum Vaccin. 2009 Aug;5(8):536-44. (PMID: 19458488) J Infect Dis. 2024 Sep 23;230(3):624-634. (PMID: 38657001) J Infect Dis. 2022 Nov 11;226(10):1731-1742. (PMID: 35535503) N Engl J Med. 2014 Feb 6;370(6):520-32. (PMID: 23614499) N Engl J Med. 2021 Mar 4;384(9):795-807. (PMID: 33306283) Open Forum Infect Dis. 2018 Dec 19;6(1):ofy352. (PMID: 30697574) N Engl J Med. 2021 Feb 4;384(5):403-416. (PMID: 33378609) N Engl J Med. 2021 Jun 10;384(23):2259-2261. (PMID: 33822494) N Engl J Med. 2021 Dec 16;385(25):2348-2360. (PMID: 34587382) NPJ Vaccines. 2023 Jul 11;8(1):98. (PMID: 37433788) Sci Rep. 2022 Jan 28;12(1):1554. (PMID: 35091640) Clin Infect Dis. 2024 Jun 14;78(6):1757-1768. (PMID: 38537255) J Infect Dis. 2012 Mar 1;205(5):703-12. (PMID: 22275399) NPJ Vaccines. 2024 Sep 7;9(1):162. (PMID: 39242587) Lancet Infect Dis. 2016 Jan;16(1):31-42. (PMID: 26546548) Vaccine. 2017 Dec 4;35(48 Pt B):6759-6765. (PMID: 29037578) Clin Vaccine Immunol. 2016 Dec 5;23(12):918-925. (PMID: 27707765) JAMA. 2014 Oct 8;312(14):1420-8. (PMID: 25291578) J Virol. 2014 Dec;88(24):14278-88. (PMID: 25275133) N Engl J Med. 2020 Dec 17;383(25):2427-2438. (PMID: 32991794) J Infect Dis. 2008 Feb 15;197(4):580-3. (PMID: 18237269) J Infect Dis. 2025 Jul 30;232(1):25-27. (PMID: 39422259) Vaccine. 2015 Oct 5;33(41):5425-5431. (PMID: 26319063) J Infect Dis. 2012 Sep 15;206(6):828-37. (PMID: 22802432) Am J Trop Med Hyg. 2019 Feb;100(2):427-433. (PMID: 30560770) N Engl J Med. 2021 Nov 4;385(19):1774-1785. (PMID: 34551225) Clin Transl Immunology. 2021 Jan 19;10(1):e1239. (PMID: 33505681) Nat Med. 2025 May;31(5):1454-1458. (PMID: 40082696) Gastroenterology. 2020 Mar;158(4):1058-1071.e6. (PMID: 31809725) J Infect Dis. 2008 Nov 1;198(9):1309-16. (PMID: 18808338) J Infect Dis. 2011 Sep 15;204(6):854-63. (PMID: 21849282) N Engl J Med. 2020 Sep 17;383(12):1191-1192. (PMID: 32813942) Proc Natl Acad Sci U S A. 2021 Aug 31;118(35):. (PMID: 34426498) J Infect Dis. 2006 Aug 15;194(4):435-43. (PMID: 16845626) Vaccine. 2019 Sep 3;37(37):5535-5543. (PMID: 31160101) Vaccine. 1999 Dec 10;18(9-10):899-906. (PMID: 10580204) Vaccine. 2022 May 20;40(23):3253-3262. (PMID: 35465983) Vaccine. 2013 Jun 24;31(29):3025-33. (PMID: 23664987) Hum Vaccin Immunother. 2020 Dec 1;16(12):3138-3145. (PMID: 32401699) N Engl J Med. 2021 Dec 23;385(26):2485-2487. (PMID: 34731553) Vaccines (Basel). 2020 Feb 06;8(1):. (PMID: 32041104) Vaccine. 2007 Dec 12;25(51):8562-73. (PMID: 18036708) J Infect Dis. 2015 Aug 15;212(4):552-61. (PMID: 25649171) MMWR Morb Mortal Wkly Rep. 2018 Oct 12;67(40):1123-1128. (PMID: 30307907) JAMA. 2003 Jun 25;289(24):3295-9. (PMID: 12824212) J Infect Dis. 2022 May 4;225(9):1513-1520. (PMID: 32658250) Lancet. 2024 Jul 27;404(10450):311. (PMID: 39067890) N Engl J Med. 2020 Nov 5;383(19):1813-1826. (PMID: 32445440) JAMA. 2004 Sep 8;292(10):1205-12. (PMID: 15353533) Vaccine. 2025 Feb 15;47:126702. (PMID: 39798434) N Engl J Med. 2022 Feb 10;386(6):531-543. (PMID: 34910859) N Engl J Med. 2002 Apr 25;346(17):1275-80. (PMID: 11923489) Vaccine. 2019 Aug 23;37(36):5161-5170. (PMID: 31375440) MMWR Morb Mortal Wkly Rep. 2012 Jan 6;60(51-52):1741-4. (PMID: 22217624) Lancet Respir Med. 2022 Sep;10(9):888-899. (PMID: 35617986) Pediatrics. 2024 Mar 1;153(3):. (PMID: 38332733) Open Forum Infect Dis. 2014 Oct 08;1(3):ofu091. (PMID: 25734159) Hepatology. 2015 Dec;62(6):1670-82. (PMID: 26251214) Nat Rev Immunol. 2021 Dec;21(12):753-755. (PMID: 34663971) Lancet. 2024 May 25;403(10441):2307-2316. (PMID: 38705159) Vaccine. 2010 Apr 9;28(17):3025-9. (PMID: 19931380) J Infect Dis. 2015 Aug 15;212(4):525-30. (PMID: 25712967) NPJ Vaccines. 2020 Jan 23;5(1):6. (PMID: 31993217) Vaccine. 2010 Aug 31;28(38):6367-73. (PMID: 20619382) J Infect Dis. 2007 Mar 15;195(6):826-32. (PMID: 17299712) J Infect Dis. 2021 Oct 28;224(8):1372-1382. (PMID: 33675226) N Engl J Med. 2021 Jan 7;384(1):80-82. (PMID: 33270381) N Engl J Med. 2006 Mar 30;354(13):1343-51. (PMID: 16571878) J Infect Dis. 2023 May 29;227(11):1303-1312. (PMID: 36484441) Science. 2021 Sep 17;373(6561):1372-1377. (PMID: 34385356) MMWR Recomm Rep. 2019 Dec 13;68(4):1-14. (PMID: 31834290) Antimicrob Agents Chemother. 2022 Apr 19;66(4):e0173221. (PMID: 35311524) Vaccine. 2021 Feb 22;39(8):1339-1348. (PMID: 33485646) MMWR Recomm Rep. 2015 Feb 20;64(RR-02):1-26. (PMID: 25695372) |
| Grant Information: | UM1 AI148689 United States AI NIAID NIH HHS; UM1 AI148685 United States AI NIAID NIH HHS; Infectious Diseases Clinical Research Consortium; UM1AI148576 United States NH NIH HHS; UM1 AI148684 United States AI NIAID NIH HHS; UM1AI148684 United States NH NIH HHS; Vaccine Treatment and Evaluation Units; UM1AI148575 United States NH NIH HHS; UM1 AI148574 United States AI NIAID NIH HHS; National Institute of Allergy and Infectious Diseases; UM1 AI148575 United States AI NIAID NIH HHS; UM1 AI148576 United States AI NIAID NIH HHS; UM1AI148574 United States NH NIH HHS; UM1AI148689 United States NH NIH HHS; UM1AI148685 United States NH NIH HHS |
| Contributed Indexing: | Keywords: clinical research; immunogenicity; pandemic; safety; vaccine |
| Substance Nomenclature: | 0 (COVID-19 Vaccines) 0 (Vaccines) |
| Entry Date(s): | Date Created: 20251010 Date Completed: 20251010 Latest Revision: 20251123 |
| Update Code: | 20251123 |
| PubMed Central ID: | PMC12513351 |
| DOI: | 10.1093/cid/ciaf380 |
| PMID: | 41071737 |
| Datenbank: | MEDLINE |
Nájsť tento článok vo Web of Science | Abstract: | Competing Interests: Potential conflicts of interest. R. L. A. has received grant support from and served as a consultant to Hillevax, Inc. K. E. L. and S. L. G. have received grant awards from Pfizer Inc. and Sanofi (exclusive of the current work). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.<br />Pathogens infecting humans continue to emerge or reemerge to cause outbreaks and widespread disease. The National Institute of Allergy and Infectious Diseases has funded Vaccine Treatment and Evaluation Units (VTEUs) for more than 50 years. VTEUs perform clinical studies to assess the safety and immunogenicity of candidate vaccines and other interventions to mitigate the impact of emerging and ongoing infectious diseases. Here, we review clinical studies conducted in the VTEUs since 2000 that have addressed emerging pathogens and other infectious agents with pandemic potential or of bioterrorism concern. The studies conducted range from phase 1 to phase 3 clinical trials, and they have included vaccines, therapeutics, and epidemiological studies. The results of the trials have guided national and often international recommendations for treatment and prevention of many of the evaluated pathogens, culminating in coronavirus disease 2019 studies that began within three months of severe acute respiratory syndrome coronavirus 2 identification. The VTEU network continues to be a critical public health resource for addressing emerging pathogens and expediting the development of safe and effective vaccines and treatments to protect at-risk populations.<br /> (© The Author(s) 2025. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved. For commercial re-use, please contact reprints@oup.com for reprints and translation rights for reprints. All other permissions can be obtained through our RightsLink service via the Permissions link on the article page on our site—for further information please contact journals.permissions@oup.com.) |
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| ISSN: | 1537-6591 |
| DOI: | 10.1093/cid/ciaf380 |