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Clinical phase 1 testing of the safety and immunogenicity of an epitope-based DNA vaccine in human immunodeficiency virus type 1-infected subjects receiving highly active antiretroviral therapy.

ABSTRACT: A DNA vaccine encoding sequence-conserved human immunodeficiency virus type 1 (HIV-1)-derived cytotoxic T-lymphocyte (CTL) epitopes from multiple HIV-1 gene products (designated EP HIV-1090) was evaluated in a placebo-controlled, dose escalation phase 1 clinical trial of HIV-1-infected subjects receiving potent combination antiretroviral therapy. Patients received four intramuscular immunizations with EP HIV-1090 over a 4-month period at one of four doses (0.5, 1.0, 2.0, or 4.0 mg) or received a placebo. The vaccine was determined to be safe and well tolerated at all doses tested. CTL responses were measured from cryopreserved peripheral blood mononuclear cells using gamma interferon enzyme-linked immunospot assays, with and without in vitro peptide stimulation (IVS). Responses to one or more vaccine epitopes were detected throughout the course of vaccination in 37.5% (12/32) and 47% (15/32) of vaccine recipients measured without and with IVS, respectively, indicating possible vaccine-induced priming of epitope-specific T cells. However, differences in rates of response to HIV-1 epitopes between vaccine and placebo recipients did not achieve statistical significance. The HIV-1 epitope-specific CTL responses measured in the peripheral blood after vaccination were often low level and short-lived, and therefore, alternative immunization schedules, routes of delivery, or vaccine formulations may be required to increase vaccine potency.

SUBMITTER: Wilson CC

PROVIDER: S-EPMC2446619 | biostudies-literature | 2008 Jun

REPOSITORIES: biostudies-literature

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Clinical phase 1 testing of the safety and immunogenicity of an epitope-based DNA vaccine in human immunodeficiency virus type 1-infected subjects receiving highly active antiretroviral therapy.

Wilson Cara C CC Newman Mark J MJ Livingston Brian D BD MaWhinney Samantha S Forster Jeri E JE Scott Jim J Schooley Robert T RT Benson Constance A CA

Clinical and vaccine immunology : CVI 20080409 6

A DNA vaccine encoding sequence-conserved human immunodeficiency virus type 1 (HIV-1)-derived cytotoxic T-lymphocyte (CTL) epitopes from multiple HIV-1 gene products (designated EP HIV-1090) was evaluated in a placebo-controlled, dose escalation phase 1 clinical trial of HIV-1-infected subjects receiving potent combination antiretroviral therapy. Patients received four intramuscular immunizations with EP HIV-1090 over a 4-month period at one of four doses (0.5, 1.0, 2.0, or 4.0 mg) or received a ...[more]

PMID: 18400976

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Project description:AimTo evaluate and compare effects of 48-week treatment with rosiglitazone and metformin on insulin resistance in patients infected with Human Immunodeficiency Virus (HIV) receiving highly active antiretroviral therapy (HAART), containing a protease inhibitor.MethodsRandomized prospective controlled clinical trial enrolled 90 male patients infected with HIV and having impaired glucose tolerance and insulin resistance (fasting insulin concentration >20 mIU/L). The patients were randomly assigned into three groups; the first group receiving 4 mg rosiglitazone once a day, the second group receiving 500 mg metformin two times a day, and the third group serving as control without hypoglycemic treatment. The primary efficacy parameters were fasting plasma glucose and insulin levels compared between baseline and week. Data on insulin resistance and beta cell function were analyzed by the Homeostasis Model Assessment (HOMA).ResultsAfter 48 weeks of treatment, the fasting insulin concentration (+/-standard deviation) in rosiglitazone group significantly declined from 39.0+/-3.35 to 19.7+/-3.99 mIU/L (P<0.001; 49% decrease) and in metformin group from 40.3+/-2.29 to 29.2+/-2.82 mIU/L (P<0.001; 27% decrease). HOMA indicated that rosiglitazone significantly reduced insulin resistance from 11.3+/-1.03 to 4.0+/-0.95 (P<0.001), compared with metformin which reduced it from 11.9+/-0.73 to 5.7+/-0.62 (P<0.001). Insulin resistance was significantly lower in the rosiglitazone group after 48 weeks (P<0.001). Metformin significantly improved beta cell function (from 257.3+/-21.91 to 707.4+/-207.32; P<0.001), as did rosiglitazone as well (from 261.3+/-27.98 to 403.3+/-162.50; P<0.001), but the improvement in the metformin group was significantly better (P<0.001). However, metformin was more efficient in improving beta cell function (from 257.3+/-21.91 to 707.4+/-207.32) than rosiglitazone (from 261.3+/-27.98 to 403.3+/-162.50).ConclusionsBoth rosiglitazone and metformin were effective and well tolerated in HIV treated with protease inhibitor-containing HAART. Rosiglitazone significantly more reduced insulin resistance, while beta cell function was significantly better in patients on metformin. Both drugs may be considered as an appropriate therapy, with rosiglitazone being a better alternative in treating insulin resistance in this patient population. ClinicalTrials.gov trial registration number: NCT00483392.

Dataset Information

Clinical phase 1 testing of the safety and immunogenicity of an epitope-based DNA vaccine in human immunodeficiency virus type 1-infected subjects receiving highly active antiretroviral therapy.

Publications

Clinical phase 1 testing of the safety and immunogenicity of an epitope-based DNA vaccine in human immunodeficiency virus type 1-infected subjects receiving highly active antiretroviral therapy.

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