FDA Reopening Comment Period for Notice of Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research
“FDA is reopening the comment period for the notice of public meeting entitled ‘Human Immunodeficiency Virus (HIV) Patient-Focused Drug Development and HIV Cure Research,’ published in the Federal Register of May 21, 2013. As part of Patient-Focused Drug Development, FDA is gathering input from HIV patients and patient advocates on current approaches to managing HIV, symptoms experienced because of HIV or its treatment, and patient perspectives related to ‘HIV cure research.’
“Comments can be submitted until September 3, 2013.”
For more information and to learn how to submit comments, read the FDA press release or view the notice at FederalRegister.gov.
Study Evaluates Safety and Comparative Immunogenicity of an HIV-1 DNA Vaccine in Combination with a Plasmid IL-12 Vaccine and the Impact of Intramuscular Electroporation for Delivery
“DNA vaccines have been very poorly immunogenic in humans but have been an effective priming modality in prime-boost regimens. Methods to increase the immunogenicity of DNA vaccines are needed. … HIV Vaccine Trials Network (HVTN) studies 070 and 080 were multicenter, randomized, clinical trials. The human immunodeficiency virus type 1 (HIV-1) PENNVAX®-B DNA vaccine (PV) is a mixture of 3 expression plasmids encoding HIV-1 Clade B Env, Gag, and Pol. The interleukin 12 (IL-12) DNA plasmid expresses human IL-12 proteins p35 and p40. Study subjects were healthy HIV-1-uninfected adults 18-50 years old. Four intramuscular vaccinations were given in HVTN 070, and 3 intramuscular vaccinations were followed by electroporation in HVTN 080. … Vaccination was safe and well tolerated. Administration of PV plus IL-12 with electroporation had a significant dose-sparing effect and provided immunogenicity superior to that observed in the trial without electroporation, despite fewer vaccinations. … Use of electroporation after PV administration provided superior immunogenicity than delivery without electroporation. This study illustrates the power of combined DNA approaches to generate impressive immune responses in humans.”
More information is available: