Juliet Mpendo1, Gaudensia Mutua2, Annet Nanvubya1, Omu Anzala2, Julien Nyombayire3, Etienne Karita3, Len Dally4, Drew Hannaman5, Matt Price6, Patricia E Fast6, Frances Priddy6, Huub C Gelderblom7, Nancy K Hills8. 1. Uganda Virus Research Institute-International AIDS Vaccine Initiative, HIV Vaccine Program, Entebbe, Uganda. 2. Kenya AIDS Vaccine Initiative, University of Nairobi, Nairobi, Kenya. 3. Project San Francisco (PSF), Kigali, Rwanda. 4. EMMES Corporation, Rockville, Maryland, United States of America. 5. Ichor Medical Systems, Inc., San Diego, California, United States of America. 6. International AIDS Vaccine Initiative (IAVI), New York, NY, United States of America. 7. Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States of America. 8. University of California at San Francisco, San Francisco, California, United States of America.
Abstract
INTRODUCTION:Intramuscular electroporation (IM/EP) is a vaccine delivery technique that improves the immunogenicity of DNA vaccines. We evaluated the acceptability and tolerability of electroporation among healthy African study participants. METHODS: Forty-five participants were administered a DNA vaccine (HIV-MAG) or placebo by electroporation at three visits occurring at four week-intervals. At the end of each visit, participants were asked to rate pain at four times: (1) when the device was placed on the skin and vaccine injected, before the electrical stimulation, (2) at the time of electrical stimulation and muscle contraction, and (3) at 10 minutes and (4) 30 minutes after the procedure was completed. For analyses, pain level was dichotomized as either "acceptable" (none/slight/uncomfortable) or "too much" (Intense, severe, and very severe) and examined over time using repeated measures models. Optional brief comments made by participants were summarized anecdotally. RESULTS:All 45 participants completed all three vaccination visits; none withdrew from the study due to the electroporation procedure. Most (76%) reported pain levels as acceptable at every time point across all vaccination visits. The majority of "unacceptable" pain was reported at the time of electrical stimulation. The majority of the participants (97%) commented that they preferred electroporation to standard injection. CONCLUSION: Repeated intramuscular electroporation for vaccine delivery was found to be acceptable and feasible among healthy African HIV vaccine trial participants. The majority of participants reported an acceptable pain level at all vaccination time points. Further investigation may be warranted into the value of EP to improve immunization outcomes. ClinicalTrials.gov NCT01496989.
RCT Entities:
INTRODUCTION: Intramuscular electroporation (IM/EP) is a vaccine delivery technique that improves the immunogenicity of DNA vaccines. We evaluated the acceptability and tolerability of electroporation among healthy African study participants. METHODS: Forty-five participants were administered a DNA vaccine (HIV-MAG) or placebo by electroporation at three visits occurring at four week-intervals. At the end of each visit, participants were asked to rate pain at four times: (1) when the device was placed on the skin and vaccine injected, before the electrical stimulation, (2) at the time of electrical stimulation and muscle contraction, and (3) at 10 minutes and (4) 30 minutes after the procedure was completed. For analyses, pain level was dichotomized as either "acceptable" (none/slight/uncomfortable) or "too much" (Intense, severe, and very severe) and examined over time using repeated measures models. Optional brief comments made by participants were summarized anecdotally. RESULTS: All 45 participants completed all three vaccination visits; none withdrew from the study due to the electroporation procedure. Most (76%) reported pain levels as acceptable at every time point across all vaccination visits. The majority of "unacceptable" pain was reported at the time of electrical stimulation. The majority of the participants (97%) commented that they preferred electroporation to standard injection. CONCLUSION: Repeated intramuscular electroporation for vaccine delivery was found to be acceptable and feasible among healthy African HIV vaccine trial participants. The majority of participants reported an acceptable pain level at all vaccination time points. Further investigation may be warranted into the value of EP to improve immunization outcomes. ClinicalTrials.gov NCT01496989.
Authors: Andrew T Catanzaro; Mario Roederer; Richard A Koup; Robert T Bailer; Mary E Enama; Martha C Nason; Julie E Martin; Steve Rucker; Charla A Andrews; Phillip L Gomez; John R Mascola; Gary J Nabel; Barney S Graham Journal: Vaccine Date: 2007-03-07 Impact factor: 3.641
Authors: Malissa C Diehl; Jessica C Lee; Stephen E Daniels; Pablo Tebas; Amir S Khan; Mary Giffear; Niranjan Y Sardesai; Mark L Bagarazzi Journal: Hum Vaccin Immunother Date: 2013-06-04 Impact factor: 3.452
Authors: Mark Wallace; Barbara Evans; Sandra Woods; Robin Mogg; Lei Zhang; Adam C Finnefrock; Dietmar Rabussay; Michael Fons; John Mallee; Devan Mehrotra; Florian Schödel; Luwy Musey Journal: Mol Ther Date: 2009-03-10 Impact factor: 11.454
Authors: Spyros A Kalams; Scott D Parker; Marnie Elizaga; Barbara Metch; Srilatha Edupuganti; John Hural; Stephen De Rosa; Donald K Carter; Kyle Rybczyk; Ian Frank; Jonathan Fuchs; Beryl Koblin; Denny H Kim; Patrice Joseph; Michael C Keefer; Lindsey R Baden; John Eldridge; Jean Boyer; Adam Sherwat; Massimo Cardinali; Mary Allen; Michael Pensiero; Chris Butler; Amir S Khan; Jian Yan; Niranjan Y Sardesai; James G Kublin; David B Weiner Journal: J Infect Dis Date: 2013-07-08 Impact factor: 5.226
Authors: Juliet Mpendo; Gaudensia Mutua; Julien Nyombayire; Rosine Ingabire; Annet Nanvubya; Omu Anzala; Etienne Karita; Peter Hayes; Jakub Kopycinski; Len Dally; Drew Hannaman; Michael A Egan; John H Eldridge; Kristen Syvertsen; Jennifer Lehrman; Beth Rasmussen; Jill Gilmour; Josephine H Cox; Patricia E Fast; Claudia Schmidt Journal: PLoS One Date: 2015-08-07 Impact factor: 3.240
Authors: Gaudensia Mutua; Bashir Farah; Robert Langat; Jackton Indangasi; Simon Ogola; Brian Onsembe; Jakub T Kopycinski; Peter Hayes; Nicola J Borthwick; Ambreen Ashraf; Len Dally; Burc Barin; Annika Tillander; Jill Gilmour; Jan De Bont; Alison Crook; Drew Hannaman; Josephine H Cox; Omu Anzala; Patricia E Fast; Marie Reilly; Kundai Chinyenze; Walter Jaoko; Tomáš Hanke; The Hiv-Core 004 Study Group Journal: Mol Ther Methods Clin Dev Date: 2016-08-31 Impact factor: 6.698