Between now and the end of October data will be here Pennvax's therapeutic results..I say this because PennvaxGP phase 1 trial is due to launch this month (sep 2013) as confrimed in may at the hvtn' closed mtg, PennvaxGP is a preventive and therapeutic vaccine
Therapeutic results for Pennvax were presented in a closed mtg March 5th at the CROI conference 2013
Potent Cellular Immune Responses Induced after Therapeutic Immunization of HIV+ Patients with PENNVAX-B DNA Vaccine Delivered by Electroporation
Lorenzo Ramirez*1, T Arango1, D Shah2, M Morrow2, J Lee2, M Naji1, K Maffei3, M Bagarazzi2, P Tebas3, and J Boyer1
1Univ of Pennsylvania Perelman Sch of Med, Philadelphia, US; 2Inovio Pharmaceuticals, Blue Bell, PA, US; and 3Univ of Pennsylvania, Philadelphia, US
Background: The goal of eradicating the HIV reservoir has renewed interest in immunotherapeutic approaches to boost T cell responses against HIV+ cells. However, individuals chronically infected with HIV respond poorly to T cell vaccines. We evaluated the use of PENNVAX-B vaccine (a gag, pol, and env combination DNA vaccine) delivered by in vivo electroporation (EP) that has proven immunogenic in HIV– individuals (HVTN 080).
Methods: We conducted a phase 1 study in well controlled, ART treated, HIV+ individuals (HIV RNA 400/µL, and nadir CD4 cells 200 cells/µL). Subjects received 4 doses (at day 0, weeks 4, 8, and 16) of 3 mg PENNVAX-B (consisting of consensus sequence HIV gag, pol, and env immunogens) intramuscularly followed by EP. Standard IFN-? ELISpot assays were performed. Positive responses were determined using a one-way ANOVA followed by Dunnett’s test, comparing each time-point to baseline. We measured the potential of cells to lyse HIV-1+ cells by measuring CD8+CD107a+ Perforin+ Granzyme B+ responses, by standard flow cytometry. Subjects were considered responders to the vaccine if responses were 50% greater than baseline. Also, the subjects’ pre-vaccination cytokine profiles were examined using a 30 cytokine Luminex plasma assay. We compared baseline cytokine profiles of the subjects who responded via ELISpot or Flow assays to those who did not respond.
Results: 12 subjects were included. 92% were male and 58% black. The vaccine was safe and well tolerated. 10 of the 12 subjects (83%) showed significant vaccine-specific T cell responses in the form of IFN-? ELISpot to at least 1/3 vaccine antigens (gag, pol, or env) throughout the immunizations. ELISpot responses were primarily mediated by CD8+ T cells. 9/11 subjects tested showed a positive CD8+CD107a+ Perforin+ Granzyme B+ response. HIV-1+ individuals, despite having well-controlled viral replication showed significantly different cytokine profiles compared to healthy controls. Importantly, baseline IL-12 p70, and MCP-1 levels were directly associated with response to the HIV-1 therapeutic vaccine.
Conclusions: PENNVAX-B induced HIV-specific CTL responses in well-controlled HIV+ individuals. The pre-vaccination cytokine environment may provide the necessary signals for T cells to respond to therapeutic vaccination, suggesting that the cytokines examined could serve as potential adjuvants in a therapeutic vaccine strategy.
possibly results around this conference
AIDS Vaccine conference Barcelona, Spain
Progress, Partnership and Perseverance. The annual AIDS Vaccine conference is the largest and most diverse international meeting of researchers, advocates, clinicians, private sector partners and public health experts working collaboratively to advance HIV vaccine science. HIV vaccine research has progressed further and faster in the last few years than at any time since the epidemic began. AIDS Vaccine 2013 will focus on partnerships and perseverance to transform these advances into a safe and effective vaccine to help end the pandemic.
Poster 288639 PENNVAX-B DNA Vaccine via Electroporation Drives Potent Cellular Immune Responses and Synthesis of Granzyme B, Perforin: Data from 3 Clinical Trials