A Phase 1 Safety and Immunogenicity Study of the Epitope Based DNA Vaccine (EP HIV-1090) in HIV-1 Infected Individuals Receiving Antiretroviral Therapy (ART)
This trial is active, not recruiting.
|Start date||October 2006|
|End date||April 2008|
|Trial size||32 participants|
|Trial identifier||NCT00532974, EP-HIV-1090|
The use of a Bioject 2000 needle free injection device (NFID) and a compressed immunization schedule will be safely tolerated and will augment the immunogenicity of the HIV-1 CTL epitope DNA vaccine (EP1090) in HIV-1 infected individuals receiving potent combination antiretroviral therapy (ART) and who have undetectable levels of viral replication in plasma.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Safety and Immunogenicity: defined as the effect of the vaccine on peripheral blood CD8 CTL responses, CD4 T cell counts, plasma HIV-1 RNA levels and clinical signs and symptoms.
time frame: six months
Male or female participants from 18 years up to 60 years old.
Inclusion Criteria: - HIV-1 Infection - CD4 Tcell count >350 - HIV-1 RNA levels to <400 copies - Negative HbsAg and anti-HCV antibody Exclusion Criteria: - Recent receipt of experimental HIV-1 vaccines - Recent use of immunomodulatory agents - Hypersensitivity or serious reactions to study vaccine components - Active opportunistic infections
|Official title||A Phase 1 Safety and Immunogenicity Study of the Pharmexa-Epimmune HIV-1 CTL Epitope-Based DNA Vaccine (EP HIV-1090) Administered Using a Biojector 2000 Needle Free Immunization Device in HIV-1 Infected Individuals Receiving Potent Combination Antiretroviral Therapy (ART)|
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