Journal
JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
Volume 71, Issue 2, Pages 163-171Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1097/QAI.0000000000000830
Keywords
HIV; therapeutic vaccination; DNA vaccine; interleukin-12; electroporation
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Funding
- National Institute of Allergy and Infectious Diseases of the National Institutes of Health [UM1 AI068634, UM1 AI068636, UM1 AI106701]
- NIAID [N01 AI80062C]
- UCSF AIDS CRS ACTG CTU [UM1 AI069496]
- Washington University in St. Louis CRS ACTG CTU Grant [U01 AI69439]
- Penn Therapeutics CRS ACTG CTU Grant [UM1 AI069534-08]
- CFAR Grant [5-P30-AI-045008-15]
- Stanford University ACTG CTU Grant [AI069556]
- UCLA CARE Center CRS ACTG CTU Grant [A1069424]
- CTRC Grant [UL1 TR000124]
- University of Rochester/Trillium Health ACTG CTU Grant [2UM1AI069511-08]
- CRC Grant [UL1 RR024160]
- University of Pittsburgh CRS ACTG CTU Grant [UM1 AI069494]
- Massachusetts General Hospital (MGH) CRS ACTG CTU Grant [2UM1AI069412-08]
- University of Colorado Hospital CRS ACTG CTU Grant [2UM1AI069432, UL1 TR001082]
- HART CRS ACTG CTU Grant [2 UM1 AI069503-08, 2 UM1 AI068636-08]
- Brigham and Women's Hospital CRS ACTG CTU Grant [2UM1AI069412-08]
- University of Cincinnati CRS ACTG CTU Grant [2UM1AI069501]
- Merck
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Background:Therapeutic vaccination is being studied in eradication and functional cure strategies for HIV-1. The Profectus Biosciences multiantigen (MAG) HIV-1 DNA vaccine encodes HIV-1 Gag/Pol, Nef/Tat/Vif, and Envelope, and interleukin-12 (IL-12) and is delivered by electroporation combined with intramuscular injection (IM-EP).Methods:Sixty-two HIV-1-infected patients on antiretroviral therapy (plasma HIV-1 RNA levels 200 copies/mL; CD4(+) T-cell counts 500 cells/mm(3)) were randomly allocated 5:1 to receive vaccine or placebo. At weeks 0, 4, and 12, 4 consecutive cohorts received 3000 g HIV MAG pDNA with 0, 50, 250, or 1000 g of IL-12 pDNA by IM-EP. A fifth cohort received HIV MAG pDNA and 1000 g of IL-12 pDNA by standard IM injection.Results:CD4(+) T cells expressing IL-2 in response to Gag and Pol and interferon- responses to Gag, Pol, and Env increased from baseline to week 14 in the low-dose (50-g) IL-12 arm vs. placebo (P < 0.05; intracellular cytokine staining). The total increase in the IL-2-expressing CD4(+) T-cell responses to any antigen was also higher in the low-dose IL-12 arm vs. placebo (P = 0.04). Cytokine responses by CD8 T cells to HIV antigens were not increased in any vaccine arm relative to placebo.Conclusions:HIV-1 MAG/low-dose IL-12 DNA vaccine delivered by IM-EP augmented CD4(+) but not CD8(+) T-cell responses to multiple HIV-1 antigens.
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