Evaluating the Safety of and Immune Response to an HIV Vaccine Followed by Booster, Administered by Two Devices, in HIV-Uninfected Adults

Summary

The purpose of this study is to evaluate the safety of and immune response to an HIV vaccine, administered using two different devices, followed by a vaccine boost, in healthy, HIV-uninfected adults.

Timeline

Start

2010-02

Primary completion

2013-12

Completion

2015-06

Publications

• Background Cristillo AD, Weiss D, Hudacik L, Restrepo S, Galmin L, Suschak J, Draghia-Akli R, Markham P, Pal R. Persistent antibody and T cell responses induced by HIV-1 DNA vaccine delivered by electroporation. Biochem Biophys Res Commun. 2008 Feb 1;366(1):29-35. doi: 10.1016/j.bbrc.2007.11.052. Epub 2007 Nov 26.
• Background Loutfy MR, Harris M, Raboud JM, Antoniou T, Kovacs C, Shen S, Dufresne S, Smaill F, Rouleau D, Rachlis A, Gough K, Lalonde R, Tsoukas C, Trottier B, Walmsley SL, Montaner JS. A large prospective study assessing injection site reactions, quality of life and preference in patients using the Biojector vs standard needles for enfuvirtide administration. HIV Med. 2007 Oct;8(7):427-32. doi: 10.1111/j.1468-1293.2007.00489.x.
• Ake JA, Schuetz A, Pegu P, Wieczorek L, Eller MA, Kibuuka H, Sawe F, Maboko L, Polonis V, Karasavva N, Weiner D, Sekiziyivu A, Kosgei J, Missanga M, Kroidl A, Mann P, Ratto-Kim S, Anne Eller L, Earl P, Moss B, Dorsey-Spitz J, Milazzo M, Laissa Ouedraogo G, Rizvi F, Yan J, Khan AS, Peel S, Sardesai NY, Michael NL, Ngauy V, Marovich M, Robb ML. Safety and Immunogenicity of PENNVAX-G DNA Prime Administered by Biojector 2000 or CELLECTRA Electroporation Device With Modified Vaccinia Ankara-CMDR Boost. J Infect Dis. 2017 Nov 27;216(9):1080-1090. doi: 10.1093/infdis/jix456.

Drugs

Indications