DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.

DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO2-powered Biojector® device was compared to delivery by needle and syringe and evaluated for safety and immunogenicity.Forty adults, 18-50 years, were randomly assigned to intramuscular (IM) va...

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Main Authors: Barney S Graham, Mary E Enama, Martha C Nason, Ingelise J Gordon, Sheila A Peel, Julie E Ledgerwood, Sarah A Plummer, John R Mascola, Robert T Bailer, Mario Roederer, Richard A Koup, Gary J Nabel, VRC 008 Study Team
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2013-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC3620125?pdf=render
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author Barney S Graham
Mary E Enama
Martha C Nason
Ingelise J Gordon
Sheila A Peel
Julie E Ledgerwood
Sarah A Plummer
John R Mascola
Robert T Bailer
Mario Roederer
Richard A Koup
Gary J Nabel
VRC 008 Study Team
author_facet Barney S Graham
Mary E Enama
Martha C Nason
Ingelise J Gordon
Sheila A Peel
Julie E Ledgerwood
Sarah A Plummer
John R Mascola
Robert T Bailer
Mario Roederer
Richard A Koup
Gary J Nabel
VRC 008 Study Team
author_sort Barney S Graham
collection DOAJ
description DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO2-powered Biojector® device was compared to delivery by needle and syringe and evaluated for safety and immunogenicity.Forty adults, 18-50 years, were randomly assigned to intramuscular (IM) vaccinations with DNA vaccine, VRC-HIVDNA016-00-VP, (weeks 0, 4, 8) by Biojector® 2000™ or needle and syringe (N/S) and boosted IM at week 24 with VRC-HIVADV014-00-VP (rAd5) with N/S at 10(10) or 10(11) particle units (PU). Equal numbers per assigned schedule had low (≤500) or high (>500) reciprocal titers of preexisting Ad5 neutralizing antibody.120 DNA and 39 rAd5 injections were given; 36 subjects completed follow-up research sample collections. IFN-γ ELISpot response rates were 17/19 (89%) for Biojector® and 13/17 (76%) for N/S delivery at Week 28 (4 weeks post rAd5 boost). The magnitude of ELISpot response was about 3-fold higher in Biojector® compared to N/S groups. Similar effects on response rates and magnitude were observed for CD8+, but not CD4+ T-cell responses by ICS. Env-specific antibody responses were about 10-fold higher in Biojector-primed subjects.DNA vaccination by Biojector® was well-tolerated and compared to needle injection, primed for greater IFN-γ ELISpot, CD8+ T-cell, and antibody responses after rAd5 boosting.ClinicalTrials.gov NCT00109629.
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spelling doaj.art-3b852a8c202e41198b2ecf9667a797762022-12-22T02:42:04ZengPublic Library of Science (PLoS)PLoS ONE1932-62032013-01-0184e5934010.1371/journal.pone.0059340DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.Barney S GrahamMary E EnamaMartha C NasonIngelise J GordonSheila A PeelJulie E LedgerwoodSarah A PlummerJohn R MascolaRobert T BailerMario RoedererRichard A KoupGary J NabelVRC 008 Study TeamDNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO2-powered Biojector® device was compared to delivery by needle and syringe and evaluated for safety and immunogenicity.Forty adults, 18-50 years, were randomly assigned to intramuscular (IM) vaccinations with DNA vaccine, VRC-HIVDNA016-00-VP, (weeks 0, 4, 8) by Biojector® 2000™ or needle and syringe (N/S) and boosted IM at week 24 with VRC-HIVADV014-00-VP (rAd5) with N/S at 10(10) or 10(11) particle units (PU). Equal numbers per assigned schedule had low (≤500) or high (>500) reciprocal titers of preexisting Ad5 neutralizing antibody.120 DNA and 39 rAd5 injections were given; 36 subjects completed follow-up research sample collections. IFN-γ ELISpot response rates were 17/19 (89%) for Biojector® and 13/17 (76%) for N/S delivery at Week 28 (4 weeks post rAd5 boost). The magnitude of ELISpot response was about 3-fold higher in Biojector® compared to N/S groups. Similar effects on response rates and magnitude were observed for CD8+, but not CD4+ T-cell responses by ICS. Env-specific antibody responses were about 10-fold higher in Biojector-primed subjects.DNA vaccination by Biojector® was well-tolerated and compared to needle injection, primed for greater IFN-γ ELISpot, CD8+ T-cell, and antibody responses after rAd5 boosting.ClinicalTrials.gov NCT00109629.http://europepmc.org/articles/PMC3620125?pdf=render
spellingShingle Barney S Graham
Mary E Enama
Martha C Nason
Ingelise J Gordon
Sheila A Peel
Julie E Ledgerwood
Sarah A Plummer
John R Mascola
Robert T Bailer
Mario Roederer
Richard A Koup
Gary J Nabel
VRC 008 Study Team
DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.
PLoS ONE
title DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.
title_full DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.
title_fullStr DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.
title_full_unstemmed DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.
title_short DNA vaccine delivered by a needle-free injection device improves potency of priming for antibody and CD8+ T-cell responses after rAd5 boost in a randomized clinical trial.
title_sort dna vaccine delivered by a needle free injection device improves potency of priming for antibody and cd8 t cell responses after rad5 boost in a randomized clinical trial
url http://europepmc.org/articles/PMC3620125?pdf=render
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