Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP<sup>®</sup> DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults
<i>Background:</i> Several techniques are under investigation to improve the immunogenicity of HIV-1 DNA vaccine candidates. DNA vaccines are advantageous due to their ease of design, expression of multiple antigens, and safety. Methods: The HVTN 098 trial assessed the PENNVAX<sup>...
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-12-01
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| Series: | Vaccines |
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| Online Access: | https://www.mdpi.com/2076-393X/8/4/741 |
| _version_ | 1827700643345727488 |
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| author | Srilatha Edupuganti Stephen C. De Rosa Marnie Elizaga Yiwen Lu Xue Han Yunda Huang Edith Swann Laura Polakowski Spyros A. Kalams Michael Keefer Janine Maenza Megan C. Wise Jian Yan Matthew P. Morrow Amir S. Khan Jean D. Boyer Laurent Humeau Scott White Niranjan Y. Sardesai Mark L. Bagarazzi Peter B. Gilbert James G. Kublin Lawrence Corey David B. Weiner on behalf of the HVTN 098 Study Team the NIAID-Funded HIV Vaccine Trials Network |
| author_facet | Srilatha Edupuganti Stephen C. De Rosa Marnie Elizaga Yiwen Lu Xue Han Yunda Huang Edith Swann Laura Polakowski Spyros A. Kalams Michael Keefer Janine Maenza Megan C. Wise Jian Yan Matthew P. Morrow Amir S. Khan Jean D. Boyer Laurent Humeau Scott White Niranjan Y. Sardesai Mark L. Bagarazzi Peter B. Gilbert James G. Kublin Lawrence Corey David B. Weiner on behalf of the HVTN 098 Study Team the NIAID-Funded HIV Vaccine Trials Network |
| author_sort | Srilatha Edupuganti |
| collection | DOAJ |
| description | <i>Background:</i> Several techniques are under investigation to improve the immunogenicity of HIV-1 DNA vaccine candidates. DNA vaccines are advantageous due to their ease of design, expression of multiple antigens, and safety. Methods: The HVTN 098 trial assessed the PENNVAX<sup>®</sup>-GP DNA vaccine (encoding HIV <i>env</i>, <i>gag</i>, <i>pol</i>) administered with or without plasmid IL-12 at 0-, 1-, 3-, and 6-month timepoints via intradermal (ID) or intramuscular (IM) electroporation (EP) in healthy, adult participants. We report on safety, tolerability, and acceptability. Results: HVTN 098 enrolled 94 participants: 85 received PENNVAX<sup>®</sup>-GP and nine received placebo. Visual analog scale (VAS) pain scores immediately after each vaccination were lower in the ID/EP than in the IM/EP group (medians 4.1–4.6 vs. 6–6.5, <i>p</i> < 0.01). IM/EP participants reported greater pain and/or tenderness at the injection site. Most ID/EP participants had skin lesions such as scabs/eschars, scars, and pigmentation changes, which resolved within 6 months in 51% of participants (24/55). Eighty-two percent of IM/EP and 92% of ID/EP participant survey responses showed acceptable levels of discomfort. Conclusions: ID/EP and IM/EP are distinct experiences; however, HIV-1 DNA vaccination by either route was safe, tolerable and acceptable by most study participants. |
| first_indexed | 2024-03-10T14:16:56Z |
| format | Article |
| id | doaj.art-c5714f0380a34333bb5f95d0bc5749e7 |
| institution | Directory Open Access Journal |
| issn | 2076-393X |
| language | English |
| last_indexed | 2024-03-10T14:16:56Z |
| publishDate | 2020-12-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Vaccines |
| spelling | doaj.art-c5714f0380a34333bb5f95d0bc5749e72023-11-20T23:43:33ZengMDPI AGVaccines2076-393X2020-12-018474110.3390/vaccines8040741Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP<sup>®</sup> DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy AdultsSrilatha Edupuganti0Stephen C. De Rosa1Marnie Elizaga2Yiwen Lu3Xue Han4Yunda Huang5Edith Swann6Laura Polakowski7Spyros A. Kalams8Michael Keefer9Janine Maenza10Megan C. Wise11Jian Yan12Matthew P. Morrow13Amir S. Khan14Jean D. Boyer15Laurent Humeau16Scott White17Niranjan Y. Sardesai18Mark L. Bagarazzi19Peter B. Gilbert20James G. Kublin21Lawrence Corey22David B. Weiner23on behalf of the HVTN 098 Study Teamthe NIAID-Funded HIV Vaccine Trials NetworkDivision of Infectious Disease, Department of Medicine, Emory University, Atlanta, GA 30322, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USADivision of AIDS, NIH, Bethesda, MD 20892, USADivision of AIDS, NIH, Bethesda, MD 20892, USAVanderbilt University Medical Center, Nashville, TN 37232, USADepartment of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, NY 14642, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USAInovio Pharmaceuticals Inc. Plymouth Meeting, PA 19462, USAInovio Pharmaceuticals Inc. Plymouth Meeting, PA 19462, USAInovio Pharmaceuticals Inc. Plymouth Meeting, PA 19462, USAInovio Pharmaceuticals Inc. Plymouth Meeting, PA 19462, USAInovio Pharmaceuticals Inc. Plymouth Meeting, PA 19462, USAInovio Pharmaceuticals Inc. Plymouth Meeting, PA 19462, USAInovio Pharmaceuticals Inc. Plymouth Meeting, PA 19462, USAInovio Pharmaceuticals Inc. Plymouth Meeting, PA 19462, USAInovio Pharmaceuticals Inc. Plymouth Meeting, PA 19462, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USAVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USAWistar Institute, Philadelphia, PA 19104, USA<i>Background:</i> Several techniques are under investigation to improve the immunogenicity of HIV-1 DNA vaccine candidates. DNA vaccines are advantageous due to their ease of design, expression of multiple antigens, and safety. Methods: The HVTN 098 trial assessed the PENNVAX<sup>®</sup>-GP DNA vaccine (encoding HIV <i>env</i>, <i>gag</i>, <i>pol</i>) administered with or without plasmid IL-12 at 0-, 1-, 3-, and 6-month timepoints via intradermal (ID) or intramuscular (IM) electroporation (EP) in healthy, adult participants. We report on safety, tolerability, and acceptability. Results: HVTN 098 enrolled 94 participants: 85 received PENNVAX<sup>®</sup>-GP and nine received placebo. Visual analog scale (VAS) pain scores immediately after each vaccination were lower in the ID/EP than in the IM/EP group (medians 4.1–4.6 vs. 6–6.5, <i>p</i> < 0.01). IM/EP participants reported greater pain and/or tenderness at the injection site. Most ID/EP participants had skin lesions such as scabs/eschars, scars, and pigmentation changes, which resolved within 6 months in 51% of participants (24/55). Eighty-two percent of IM/EP and 92% of ID/EP participant survey responses showed acceptable levels of discomfort. Conclusions: ID/EP and IM/EP are distinct experiences; however, HIV-1 DNA vaccination by either route was safe, tolerable and acceptable by most study participants.https://www.mdpi.com/2076-393X/8/4/741intramuscularintradermalelectroporationHIV vaccineDNA vaccineIL-12 |
| spellingShingle | Srilatha Edupuganti Stephen C. De Rosa Marnie Elizaga Yiwen Lu Xue Han Yunda Huang Edith Swann Laura Polakowski Spyros A. Kalams Michael Keefer Janine Maenza Megan C. Wise Jian Yan Matthew P. Morrow Amir S. Khan Jean D. Boyer Laurent Humeau Scott White Niranjan Y. Sardesai Mark L. Bagarazzi Peter B. Gilbert James G. Kublin Lawrence Corey David B. Weiner on behalf of the HVTN 098 Study Team the NIAID-Funded HIV Vaccine Trials Network Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP<sup>®</sup> DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults Vaccines intramuscular intradermal electroporation HIV vaccine DNA vaccine IL-12 |
| title | Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP<sup>®</sup> DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults |
| title_full | Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP<sup>®</sup> DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults |
| title_fullStr | Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP<sup>®</sup> DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults |
| title_full_unstemmed | Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP<sup>®</sup> DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults |
| title_short | Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP<sup>®</sup> DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults |
| title_sort | intramuscular and intradermal electroporation of hiv 1 pennvax gp sup r sup dna vaccine and il 12 is safe tolerable acceptable in healthy adults |
| topic | intramuscular intradermal electroporation HIV vaccine DNA vaccine IL-12 |
| url | https://www.mdpi.com/2076-393X/8/4/741 |
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