@article{Nilsson:2015:10.1371/journal.pone.0131748,
author = {Nilsson, C and Hejdeman, B and Godoy-Ramirez, K and Tecleab, T and Scarlatti, G and Brove, A and Earl, PL and Stout, RR and Robb, ML and Shattock, RJ and Biberfeld, G and Sandstrom, E and Wahren, B},
doi = {10.1371/journal.pone.0131748},
journal = {PLOS One},
title = {HIV-DNA Given with or without Intradermal Electroporation Is Safe and Highly Immunogenic in Healthy Swedish HIV-1 DNA/MVA Vaccinees: A Phase I Randomized Trial},
url = {http://dx.doi.org/10.1371/journal.pone.0131748},
volume = {10},
year = {2015}
}

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TY  - JOUR
AB  - BackgroundWe compared safety and immunogenicity of intradermal (ID) vaccination with and withoutelectroporation (EP) in a phase I randomized placebo-controlled trial of an HIV-DNA primeHIV-MVA boost vaccine in healthy Swedish volunteers.MethodsHIV-DNA plasmids encoding HIV-1 genes gp160 subtypes A, B and C; Rev B; Gag A and Band RTmut B were given ID at weeks 0, 6 and 12 in a dose of 0.6 mg. Twenty-five volunteersreceived vaccine using a needle-free device (ZetaJet) with (n=16) or without (n=9) IDEP (Dermavax). Five volunteers were placebo recipients. Boosting with recombinant MVACMDRexpressing HIV-1 Env, Gag, Pol of CRF01_AE (HIV-MVA) or placebo was performedat weeks 24 and 40. Nine of the vaccinees received a subtype C CN54 gp140 proteinboost together with HIV-MVA.ResultsThe ID/EP delivery was very well tolerated. After three HIV-DNA immunizations, no statisticallysignificant difference was seen in the IFN-γ ELISpot response rate to Gag between HIV-DNA ID/EP recipients (5/15, 33%) and HIV-DNA ID recipients (1/7, 14%, p=0.6158).The first HIV-MVA or HIV-MVA+gp140 vaccination increased the IFN-γ ELISpot responserate to 18/19 (95%). CD4+ and/or CD8+ T cell responses to Gag or Env were demonstrablein 94% of vaccinees. A balanced CD4+ and CD8+ T cell response was noted, with 78% and71% responders, respectively. IFN-γ and IL-2 dominated the CD4+ T cell response to Gagand Env. The CD8+ response to Gag was broader with expression of IFN-γ, IL-2, MIP-1βand/or CD107. No differences were seen between DNA vaccine groups. Binding antibodieswere induced after the second HIV-MVA+/-gp140 in 93% of vaccinees to subtype C Env,with the highest titers among EP/gp140 recipients.ConclusionIntradermal electroporation of HIV-DNA was well tolerated. Strong cell- and antibody-mediatedimmune responses were elicited by the HIV-DNA prime and HIV-MVA boosting regimen,with or without intradermal electroporation use.
AU  - Nilsson,C
AU  - Hejdeman,B
AU  - Godoy-Ramirez,K
AU  - Tecleab,T
AU  - Scarlatti,G
AU  - Brove,A
AU  - Earl,PL
AU  - Stout,RR
AU  - Robb,ML
AU  - Shattock,RJ
AU  - Biberfeld,G
AU  - Sandstrom,E
AU  - Wahren,B
DO  - 10.1371/journal.pone.0131748
PY  - 2015///
SN  - 1932-6203
TI  - HIV-DNA Given with or without Intradermal Electroporation Is Safe and Highly Immunogenic in Healthy Swedish HIV-1 DNA/MVA Vaccinees: A Phase I Randomized Trial
T2  - PLOS One
UR  - http://dx.doi.org/10.1371/journal.pone.0131748
UR  - http://hdl.handle.net/10044/1/26317
VL  - 10
ER  - 

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