A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection

Michael C. Sneller; J. Shawn Justement; Kathleen R. Gittens; Mary E. Petrone; Katherine E. Clarridge; Michael A. Proschan; Richard Kwan; Victoria Shi; Jana Blazkova; Eric W. Refsland; Daryl E. Morris; Kristen W. Cohen; M. Juliana McElrath; Rong Xu; Michael A. Egan; John H. Eldridge; Erika Benko; Colin Kovacs; Susan Moir; Tae-Wook Chun; Anthony S. Fauci

doi:10.1126/scitranslmed.aan8848

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A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection

View ORCID ProfileMichael C. Sneller¹,
J. Shawn Justement¹,
Kathleen R. Gittens²,
Mary E. Petrone¹,
View ORCID ProfileKatherine E. Clarridge¹,
View ORCID ProfileMichael A. Proschan³,
Richard Kwan²,
Victoria Shi¹,
View ORCID ProfileJana Blazkova¹,
View ORCID ProfileEric W. Refsland¹,
View ORCID ProfileDaryl E. Morris⁴,
View ORCID ProfileKristen W. Cohen⁴,
View ORCID ProfileM. Juliana McElrath⁴,⁵,
View ORCID ProfileRong Xu⁶,
Michael A. Egan⁶,
John H. Eldridge⁶,
Erika Benko⁷,
Colin Kovacs⁷,⁸,
Susan Moir¹,
View ORCID ProfileTae-Wook Chun¹,*,† and
Anthony S. Fauci¹,*

¹Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.
²Critical Care Medicine Department, Clinical Center, NIH, Bethesda, MD 20892, USA.
³Biostatistics Research Branch, NIAID, NIH, Bethesda, MD 20892, USA.
⁴Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.
⁵Department of Global Health, University of Washington, Seattle, WA 98195, USA.
⁶Profectus BioSciences Inc., Tarrytown, NY 10591, USA.
⁷Maple Leaf Medical Clinic, Toronto, Ontario M5G 1K2, Canada.
⁸Department of Medicine, University of Toronto, Toronto, Ontario M5S 1A1, Canada.

↵†Corresponding author. Email: twchun{at}nih.gov

↵* These authors contributed equally to this work.

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Science Translational Medicine 06 Dec 2017:
Vol. 9, Issue 419, eaan8848
DOI: 10.1126/scitranslmed.aan8848

Michael C. Sneller

1Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.

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J. Shawn Justement

1Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.

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Kathleen R. Gittens

2Critical Care Medicine Department, Clinical Center, NIH, Bethesda, MD 20892, USA.

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Mary E. Petrone

1Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.

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Katherine E. Clarridge

1Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.

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Michael A. Proschan

3Biostatistics Research Branch, NIAID, NIH, Bethesda, MD 20892, USA.

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Richard Kwan

2Critical Care Medicine Department, Clinical Center, NIH, Bethesda, MD 20892, USA.

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Victoria Shi

1Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.

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Jana Blazkova

1Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.

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Eric W. Refsland

1Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.

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Daryl E. Morris

4Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.

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Kristen W. Cohen

4Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.

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M. Juliana McElrath

4Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA.

5Department of Global Health, University of Washington, Seattle, WA 98195, USA.

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Rong Xu

6Profectus BioSciences Inc., Tarrytown, NY 10591, USA.

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Michael A. Egan

6Profectus BioSciences Inc., Tarrytown, NY 10591, USA.

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John H. Eldridge

6Profectus BioSciences Inc., Tarrytown, NY 10591, USA.

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Erika Benko

7Maple Leaf Medical Clinic, Toronto, Ontario M5G 1K2, Canada.

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Colin Kovacs

7Maple Leaf Medical Clinic, Toronto, Ontario M5G 1K2, Canada.

8Department of Medicine, University of Toronto, Toronto, Ontario M5S 1A1, Canada.

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Susan Moir

1Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.

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Tae-Wook Chun

1Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.

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For correspondence: twchun@nih.gov

Anthony S. Fauci

1Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, MD 20892, USA.

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A randomized controlled safety/efficacy trial of therapeutic vaccination in HIV-infected individuals who initiated antiretroviral therapy early in infection

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