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Heterologous cAd3-Ebola and MVA-EbolaZ vaccines are safe and immunogenic in US and Uganda phase 1/1b trials.
Happe, Myra; Hofstetter, Amelia R; Wang, Jing; Yamshchikov, Galina V; Holman, LaSonji A; Novik, Laura; Strom, Larisa; Kiweewa, Francis; Wakabi, Salim; Millard, Monica; Kelley, Colleen F; Kabbani, Sarah; Edupuganti, Srilatha; Beck, Allison; Kaltovich, Florence; Murray, Tamar; Tsukerman, Susanna; Carr, Derick; Ashman, Carl; Stanley, Daphne A; Ploquin, Aurélie; Bailer, Robert T; Schwartz, Richard; Cham, Fatim; Tindikahwa, Allan; Hu, Zonghui; Gordon, Ingelise J; Rouphael, Nadine; Houser, Katherine V; Coates, Emily E; Graham, Barney S; Koup, Richard A; Mascola, John R; Sullivan, Nancy J; Robb, Merlin L; Ake, Julie A; Lyke, Kirsten E; Mulligan, Mark J; Ledgerwood, Julie E; Kibuuka, Hannah.
Affiliation
  • Happe M; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA. myra.happe@nih.gov.
  • Hofstetter AR; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Wang J; Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, Frederick, MD, USA.
  • Yamshchikov GV; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Holman LA; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Novik L; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Strom L; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Kiweewa F; Makerere University-Walter Reed Project, Kampala, Uganda.
  • Wakabi S; Makerere University-Walter Reed Project, Kampala, Uganda.
  • Millard M; Walter Reed Army Institute of Research, Silver Spring, MD, USA.
  • Kelley CF; Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA.
  • Kabbani S; Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA.
  • Edupuganti S; Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA.
  • Beck A; Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA.
  • Kaltovich F; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Murray T; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Tsukerman S; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Carr D; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Ashman C; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Stanley DA; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Ploquin A; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Bailer RT; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Schwartz R; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Cham F; Makerere University-Walter Reed Project, Kampala, Uganda.
  • Tindikahwa A; Makerere University-Walter Reed Project, Kampala, Uganda.
  • Hu Z; Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Gordon IJ; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Rouphael N; Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA.
  • Houser KV; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Coates EE; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Graham BS; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Koup RA; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Mascola JR; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Sullivan NJ; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
  • Robb ML; Walter Reed Army Institute of Research, Silver Spring, MD, USA.
  • Ake JA; Henry M. Jackson Foundation for the Advancement of Military Medicine, Bethesda, MD, USA.
  • Lyke KE; Walter Reed Army Institute of Research, Silver Spring, MD, USA.
  • Mulligan MJ; University of Maryland School of Medicine, Center for Vaccine Development and Global Health, Baltimore, MD, USA.
  • Ledgerwood JE; Department of Medicine, Division of Infectious Diseases, The Hope Clinic of the Emory Vaccine Center, Emory University, Atlanta, GA, USA.
  • Kibuuka H; Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
NPJ Vaccines ; 9(1): 67, 2024 Mar 29.
Article in En | MEDLINE | ID: mdl-38553525
ABSTRACT
Ebola virus disease (EVD) is a filoviral infection caused by virus species of the Ebolavirus genus including Zaire ebolavirus (EBOV) and Sudan ebolavirus (SUDV). We investigated the safety and immunogenicity of a heterologous prime-boost regimen involving a chimpanzee adenovirus 3 vectored Ebola vaccine [either monovalent (cAd3-EBOZ) or bivalent (cAd3-EBO)] prime followed by a recombinant modified vaccinia virus Ankara EBOV vaccine (MVA-EbolaZ) boost in two phase 1/1b randomized open-label clinical trials in healthy adults in the United States (US) and Uganda (UG). Trial US (NCT02408913) enrolled 140 participants, including 26 EVD vaccine-naïve and 114 cAd3-Ebola-experienced participants (April-November 2015). Trial UG (NCT02354404) enrolled 90 participants, including 60 EVD vaccine-naïve and 30 DNA Ebola vaccine-experienced participants (February-April 2015). All tested vaccines and regimens were safe and well tolerated with no serious adverse events reported related to study products. Solicited local and systemic reactogenicity was mostly mild to moderate in severity. The heterologous prime-boost regimen was immunogenic, including induction of durable antibody responses which peaked as early as two weeks and persisted up to one year after each vaccination. Different prime-boost intervals impacted the magnitude of humoral and cellular immune responses. The results from these studies demonstrate promising implications for use of these vaccines in both prophylactic and outbreak settings.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: NPJ Vaccines Year: 2024 Document type: Article Affiliation country: Country of publication:
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Full text: 1 Collection: 01-internacional Database: MEDLINE Language: En Journal: NPJ Vaccines Year: 2024 Document type: Article Affiliation country: Country of publication: