Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine

Andrew T. Catanzaro; Mario Roederer; Richard A. Koup; Robert T. Bailer; Mary E. Enama; Martha C. Nason; Julie E. Martin; Steve Rucker; Charla A. Andrews; Phillip L. Gomez; John R. Mascola; Gary J. Nabel; Barney S. Graham

doi:10.1016/j.vaccine.2007.02.050

Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine

Andrew T. Catanzaro, Mario Roederer, Richard A. Koup, Robert T. Bailer, Mary E. Enama, Martha C. Nason, Julie E. Martin, Steve Rucker, Charla A. Andrews, Phillip L. Gomez, John R. Mascola, Gary J. Nabel, Barney S. Graham

Research output: Contribution to journal › Article › peer-review

127 Scopus citations

Abstract

Needle-free delivery of a six-plasmid HIV-1 DNA vaccine encoding EnvA, EnvB, EnvC, and subtype B Gag, Pol, and Nef underwent open-label evaluation in 15 subjects; 14 completed the 0, 1, 2 month vaccination schedule. T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4⁺ [13/14 (93%)] and CD8⁺ [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation.

Original language	English (US)
Pages (from-to)	4085-4092
Number of pages	8
Journal	Vaccine
Volume	25
Issue number	20
DOIs	https://doi.org/10.1016/j.vaccine.2007.02.050
State	Published - May 16 2007
Externally published	Yes

Keywords

AIDS
Envelope
Gag
Nef
Pol
Prevention
Promoter
T cell response

ASJC Scopus subject areas

Immunology
Microbiology
Virology
Infectious Diseases
Public Health, Environmental and Occupational Health
General Veterinary

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10.1016/j.vaccine.2007.02.050

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title = "Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine",

abstract = "Needle-free delivery of a six-plasmid HIV-1 DNA vaccine encoding EnvA, EnvB, EnvC, and subtype B Gag, Pol, and Nef underwent open-label evaluation in 15 subjects; 14 completed the 0, 1, 2 month vaccination schedule. T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4+ [13/14 (93%)] and CD8+ [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation.",

keywords = "AIDS, Envelope, Gag, Nef, Pol, Prevention, Promoter, T cell response",

author = "Catanzaro, {Andrew T.} and Mario Roederer and Koup, {Richard A.} and Bailer, {Robert T.} and Enama, {Mary E.} and Nason, {Martha C.} and Martin, {Julie E.} and Steve Rucker and Andrews, {Charla A.} and Gomez, {Phillip L.} and Mascola, {John R.} and Nabel, {Gary J.} and Graham, {Barney S.}",

year = "2007",

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doi = "10.1016/j.vaccine.2007.02.050",

language = "English (US)",

volume = "25",

pages = "4085--4092",

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T1 - Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine

AU - Catanzaro, Andrew T.

AU - Roederer, Mario

AU - Koup, Richard A.

AU - Bailer, Robert T.

AU - Enama, Mary E.

AU - Nason, Martha C.

AU - Martin, Julie E.

AU - Rucker, Steve

AU - Andrews, Charla A.

AU - Gomez, Phillip L.

AU - Mascola, John R.

AU - Nabel, Gary J.

AU - Graham, Barney S.

PY - 2007/5/16

Y1 - 2007/5/16

N2 - Needle-free delivery of a six-plasmid HIV-1 DNA vaccine encoding EnvA, EnvB, EnvC, and subtype B Gag, Pol, and Nef underwent open-label evaluation in 15 subjects; 14 completed the 0, 1, 2 month vaccination schedule. T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4+ [13/14 (93%)] and CD8+ [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation.

AB - Needle-free delivery of a six-plasmid HIV-1 DNA vaccine encoding EnvA, EnvB, EnvC, and subtype B Gag, Pol, and Nef underwent open-label evaluation in 15 subjects; 14 completed the 0, 1, 2 month vaccination schedule. T cell responses to HIV-specific peptide pools were detected by intracellular cytokine staining of CD4+ [13/14 (93%)] and CD8+ [5/14 (36%)], and by ELISpot in 11/14 (79%). Ten of 14 (71%) had ELISA antibody responses to Env proteins. Compared to a four-plasmid product, Gag- and Nef-specific T cell responses were improved, while Env-specific responses were maintained. This candidate vaccine has now advanced to Phase II evaluation.

KW - AIDS

KW - Envelope

KW - Gag

KW - Nef

KW - Pol

KW - Prevention

KW - Promoter

KW - T cell response

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Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

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