Abstract
This study evaluated the safety and immunogenicity of PENNVAX-B in 12 HIV infected individuals. PENNVAX-B is a combination of three optimized synthetic plasmids encoding for multiclade HIV Gag and Pol and a consensus CladeB Env delivered by electroporation. HIV infected individuals whose virus was effectively suppressed using highly active antiretroviral therapy (HAART) received PENNVAX-B DNA followed by electroporation with CELLECTRA-5P at study weeks 0, 4, 8, and 16. Local administration site and systemic reactions to PENNVAX-B were recorded after each treatment along with any adverse events. Pain of the treatment procedure was assessed using a Visual Analog Scale. Whole PBMCs were isolated for use in IFN ELISpot and Flow Cytometric assays. PENNVAX-B was generally safe and well tolerated. Overall, the four dose regimen was not associated with any serious adverse events or severe local or systemic reactions. A rise in antigen-specific SFU was detected in the INFγ ELISpot assay in all 12 participants. T cells from 8/12 participants loaded with both granzyme B and perforin in response to HIV antigen, an immune finding characteristic of long-term nonprogressors (LTNPs) and elite controllers (ECs). Thus administration of PENNVAX-B may prove useful adjunctive therapy to ART for treatment and control of HIV infection.
Publication types
-
Research Support, N.I.H., Extramural
MeSH terms
-
AIDS Vaccines / administration & dosage
-
AIDS Vaccines / chemistry
-
AIDS Vaccines / genetics
-
AIDS Vaccines / immunology*
-
Adult
-
Antiretroviral Therapy, Highly Active*
-
Consensus Sequence
-
Enzyme-Linked Immunospot Assay
-
Female
-
Granzymes / biosynthesis*
-
Granzymes / genetics
-
HIV Infections / immunology
-
HIV Infections / pathology
-
HIV Infections / therapy*
-
HIV Infections / virology
-
HIV-1 / immunology
-
Humans
-
Immunity, Cellular
-
Interferon-gamma / biosynthesis
-
Interferon-gamma / metabolism
-
Leukocytes, Mononuclear / immunology*
-
Leukocytes, Mononuclear / pathology
-
Leukocytes, Mononuclear / virology
-
Male
-
Middle Aged
-
Perforin / biosynthesis*
-
Perforin / genetics
-
Vaccination
-
Vaccines, Synthetic
-
env Gene Products, Human Immunodeficiency Virus / chemistry
-
env Gene Products, Human Immunodeficiency Virus / genetics
-
env Gene Products, Human Immunodeficiency Virus / immunology
-
gag Gene Products, Human Immunodeficiency Virus / chemistry
-
gag Gene Products, Human Immunodeficiency Virus / genetics
-
gag Gene Products, Human Immunodeficiency Virus / immunology
-
pol Gene Products, Human Immunodeficiency Virus / chemistry
-
pol Gene Products, Human Immunodeficiency Virus / genetics
-
pol Gene Products, Human Immunodeficiency Virus / immunology
Substances
-
AIDS Vaccines
-
Vaccines, Synthetic
-
env Gene Products, Human Immunodeficiency Virus
-
gag Gene Products, Human Immunodeficiency Virus
-
pol Gene Products, Human Immunodeficiency Virus
-
Perforin
-
Interferon-gamma
-
Granzymes