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Clinical Trials Title: IAVI B004, "A Phase 1 Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of a Multiantigen (HIV-MAG) plasmid DNA (PDNA) Vaccine co-administered with Recombinant Human IL-12 pDNA (GENEVAX®IL-12) followed or preceded by Recombinant Ad35-GRIN/ENV Vaccine in HN-Uninfected, Healthy Volunteers". Sponsor: International AIDS Vaccine Initiative Clinicaltrials.gov Identifier: Link: http://www.iavi.org/research-development/trials/Pages/ClinicalTrials.aspx Status: This study is expected to begin recruiting participants in Africa at the following sites: Kenya AIDS Vaccine Initiative, Nairobi, Kenya Project San Francisco, Kigali, Rwanda Uganda Virus Research Institute, Entebbe, Uganda Description: The proposed Phase 1 clinical study will investigate the safety and tolerability of sequential administration of HIV-1 Multiantigen pDNA Vaccine (ProfectusVax HIV-1 gag/pol and ProfectusVax HIV-1 nef/tat/vif, env) (hereafter known as HIV-MAG) and Human IL-12 pDNA (hereafter known as GENEVAX®IL-12) injected intramuscularly followed immediately by in vivo electroporation (IM/EP) and followed at an interval of 4 months by Ad35-GRIN/ENV by intramuscular injection (IM). The HIV-MAG will be given once or three times (Months 0, 1, 2). Alternatively, Ad35-GRIN/ENV will be given first followed by HIV-MAG at 4 months. This study will attempt to replicate, in humans, the immune responses seen in non-human primates that had a 4-log reduction in SIV viral load following SIVmac239 challenge. This approach is being developed through collaboration between the International AIDS Vaccine Initiative (lAVI, New York, NY, USA), Profectus Biosciences, Inc. (Tarrytown, New York, NY, USA) and Ichor Medical Systems, Inc (San Diego, CA, USA).Title: Safety of and immune response to an investigational therapeutic HIV-1 vaccine with or without interleukin-12 (IL-12) in HIV-1 infected adults Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Clinicaltrials.gov Identifier: NCT01266616 Link: http://clinicaltrials.gov/ct2/show/NCT01266616?term=A5281&rank=1 Status: This study is currently recruiting participants.Description : Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural immune response. There are currently no FDA-approved therapeutic HIV vaccines. This Phase 1 study will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is safe and effective. This study will also test a new way of administering the vaccine called electroporation (EP) using a device developed by Ichor Medical Systems. Title: A phase 1 clinical trial to evaluate the safety and immunogenicity of VSVIN HIV gag vaccine given intramuscularly in healthy, HIV-1–uninfected adult participants Sponsor:National Institute of Allergy and Infectious Diseases (NIAID)Clinicaltrials.gov Identifier: NCT01438606 Link: http://www.clinicaltrials.gov/ct2/show/NCT01438606?term=hvtn+090&rank=1 Status: Open for enrollment. Description: This is a phase 1 study of an HIV vaccine that uses Vesicular Stomatitis Virus (VSV) as the vaccine vector. This is a first-in-humans study that will establish the safety and the maximum tolerated dose of the vaccine. Pending the outcome of this study, the HVTN plans to give the VSV vaccine as a boost to participants in HVTN 087, which gives a pDNA vaccine made by Profectus as the prime. |
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