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

被引：68

作者：

Graham, Barney S. ^{[1
]}

Enama, Mary E. ^{[1
]}

Nason, Martha C. ^{[2
]}

Gordon, Ingelise J. ^{[1
]}

Peel, Sheila A. ^{[3
]}

Ledgerwood, Julie E. ^{[1
]}

Plummer, Sarah A. ^{[1
]}

Mascola, John R. ^{[1
]}

Bailer, Robert T. ^{[1
]}

Roederer, Mario ^{[1
]}

Koup, Richard A. ^{[1
]}

Nabel, Gary J. ^{[1
]}

机构：

[1] NIAID, Vaccine Res Ctr, NIH, Bethesda, MD 20892 USA

[2] NIAID, Biostat Res Branch, Div Clin Res, NIH, Bethesda, MD 20892 USA

[3] Walter Reed Army Inst Res, US Mil HIV Res Program, Silver Spring, MD USA

来源：

PLOS ONE | 2013年 / 8卷 / 04期

关键词：

HEPATITIS-A VACCINE; T-CELL RESPONSES; NEUTRALIZING ANTIBODY; CANDIDATE VACCINE; HEALTHY-ADULTS; IMMUNOGENICITY EVALUATION; PHASE-1; SAFETY; JET INJECTION; PLASMID DNA; HIV-1;

D O I：

10.1371/journal.pone.0059340

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

070301 [无机化学]; 070403 [天体物理学]; 070507 [自然资源与国土空间规划学]; 090105 [作物生产系统与生态工程];

摘要：

Background: DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO2-powered Biojector (R) device was compared to delivery by needle and syringe and evaluated for safety and immunogenicity. Methods: 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 (R) 2000 (TM) 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. Results: 120 DNA and 39 rAd5 injections were given; 36 subjects completed follow-up research sample collections. IFN-gamma ELISpot response rates were 17/19 (89%) for Biojector (R) 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 (R) 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. Conclusions: DNA vaccination by Biojector (R) was well-tolerated and compared to needle injection, primed for greater IFN-gamma ELISpot, CD8+ T-cell, and antibody responses after rAd5 boosting. Trial Registration: ClinicalTrials.gov NCT00109629

引用

页数：11

共 34 条

[1]

Enhancement of the immune response in rabbits to a malaria DNA vaccine by immunization with a needle-free jet device [J].

Aguiar, JC ;

Hedstrom, RC ;

Rogers, WO ;

Charoenvit, Y ;

Sacci, JB ;

Lanar, DE ;

Majam, VF ;

Stout, RR ;

Hoffman, SL .

VACCINE, 2001, 20 (1-2) :275-280

[2]

A human T-cell leukemia virus type 1 regulatory element enhances the immunogenicity of human immunodeficiency virus type 1 DNA vaccines in mice and nonhuman primates [J].

Barouch, DH ;

Yang, ZY ;

Kong, WP ;

Korioth-Schmitz, B ;

Sumida, SM ;

Truitt, DM ;

Kishko, MG ;

Arthur, JC ;

Miura, A ;

Mascola, JR ;

Letvin, NL ;

Nabel, GJ .

JOURNAL OF VIROLOGY, 2005, 79 (14) :8828-8834

[3]

Phase I clinical evaluation of a six-plasmid multiclade HIV-1 DNA candidate vaccine [J].

Catanzaro, Andrew T. ;

Roederer, Mario ;

Koup, Richard A. ;

Bailer, Robert T. ;

Enama, Mary E. ;

Nason, Martha C. ;

Martin, Julie E. ;

Rucker, Steve ;

Andrews, Charla A. ;

Gomez, Phillip L. ;

Mascola, John R. ;

Nabel, Gary J. ;

Graham, Barney S. .

VACCINE, 2007, 25 (20) :4085-4092

[4]

Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector [J].

Catanzaro, Andrew T. ;

Koup, Richard A. ;

Roederer, Mario ;

Bailer, Robert T. ;

Enama, Mary E. ;

Moodie, Zoe ;

Gu, Lin ;

Martin, Julie E. ;

Novik, Laura ;

Chakrabarti, Bimal K. ;

Butman, Bryan T. ;

Gall, Jason G. D. ;

King, C. Richter ;

Andrews, Charla A. ;

Sheets, Rebecca ;

Gomez, Phillip L. ;

Mascola, John R. ;

Nabel, Gary J. ;

Graham, Barney S. .

JOURNAL OF INFECTIOUS DISEASES, 2006, 194 (12) :1638-1649

[5]

A Phase IIA Randomized Clinical Trial of a Multiclade HIV-1 DNA Prime Followed by a Multiclade rAd5 HIV-1 Vaccine Boost in Healthy Adults (HVTN204) [J].

Churchyard, Gavin J. ;

Morgan, Cecilia ;

Adams, Elizabeth ;

Hural, John ;

Graham, Barney S. ;

Moodie, Zoe ;

Grove, Doug ;

Gray, Glenda ;

Bekker, Linda-Gail ;

McElrath, M. Juliana ;

Tomaras, Georgia D. ;

Goepfert, Paul ;

Kalams, Spyros ;

Baden, Lindsey R. ;

Lally, Michelle ;

Dolin, Raphael ;

Blattner, William ;

Kalichman, Artur ;

Figueroa, J. Peter ;

Pape, Jean ;

Schechter, Mauro ;

Defawe, Olivier ;

De Rosa, Stephen C. ;

Montefiori, David C. ;

Nabel, Gary J. ;

Corey, Lawrence ;

Keefer, Michael C. .

PLOS ONE, 2011, 6 (08)

[6]

Vaccine-Induced HIV Seropositivity/Reactivity in Noninfected HIV Vaccine Recipients [J].

Cooper, Cristine J. ;

Metch, Barbara ;

Dragavon, Joan ;

Coombs, Robert W. ;

Baden, Lindsey R. .

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 304 (03) :275-283

[7]

HIV-DNA Priming Alters T Cell Responses to HIV-Adenovirus Vaccine Even When Responses to DNA Are Undetectable [J].

De Rosa, Stephen C. ;

Thomas, Evan P. ;

Bui, John ;

Huang, Yunda ;

deCamp, Allan ;

Morgan, Cecilia ;

Kalams, Spyros A. ;

Tomaras, Georgia D. ;

Akondy, Rama ;

Ahmed, Rafi ;

Lau, Chuen-Yen ;

Graham, Barney S. ;

Nabel, Gary J. ;

McElrath, M. Juliana .

JOURNAL OF IMMUNOLOGY, 2011, 187 (06) :3391-3401

[8]

Safety, tolerability, and lack of antibody responses after administration of a PfCSP DNA malaria vaccine via needle or needle-free jet injection, and comparison of intramuscular and combination intramuscular/intradermal routes [J].

Epstein, JE ;

Gorak, EJ ;

Charoenvit, Y ;

Wang, RB ;

Freydberg, N ;

Osinowo, O ;

Richie, TL ;

Stoltz, EL ;

Trespalacios, F ;

Nerges, J ;

Ng, J ;

Fallarme-Majam, V ;

Abot, E ;

Goh, L ;

Parker, S ;

Kumar, S ;

Hedstrom, RC ;

Norman, J ;

Stout, R ;

Hoffman, SL .

HUMAN GENE THERAPY, 2002, 13 (13) :1551-1560

[9]

Immunogenicity and safety of a new inactivated hepatitis A vaccine: A clinical trial with comparison of administration route [J].

Fisch, A ;

Cadilhac, P ;

Vidor, E ;

Prazuck, T ;

Dublanchet, A ;

Lafaix, C .

VACCINE, 1996, 14 (12) :1132-1136

[10]

Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 DNA candidate vaccine [J].

Graham, Barney S. ;

Koup, Richard A. ;

Roederer, Mario ;

Bailer, Robert T. ;

Enama, Mary E. ;

Moodie, Zoe ;

Martin, Julie E. ;

McCluskey, Margaret M. ;

Chakrabarti, Bimal K. ;

Lamoreaux, Laurie ;

Andrews, Charla A. ;

Gomez, Phillip L. ;

Mascola, John R. ;

Nabel, Gary J. .

JOURNAL OF INFECTIOUS DISEASES, 2006, 194 (12) :1650-1660

← 1 2 3 4 →