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) v...

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Published inPloS one Vol. 8; no. 4; p. e59340
Main Authors Graham, Barney S., Enama, Mary E., Nason, Martha C., Gordon, Ingelise J., Peel, Sheila A., Ledgerwood, Julie E., Plummer, Sarah A., Mascola, John R., Bailer, Robert T., Roederer, Mario, Koup, Richard A., Nabel, Gary J.
Format Journal Article
LanguageEnglish
Published United States Public Library of Science 08.04.2013
Public Library of Science (PLoS)
Subjects
Adenoviridae - genetics
Adenoviruses
Adolescent
Adult
Adults
Antibodies, Viral - immunology
Avian flu
Binding sites
Biology
Carbon dioxide
CD4 antigen
CD8 antigen
CD8-Positive T-Lymphocytes - immunology
Clinical trials
Delivery scheduling
Deoxyribonucleic acid
DNA
DNA vaccines
DNA, Recombinant - genetics
Dose-Response Relationship, Immunologic
Drug delivery systems
Enzyme-linked immunosorbent assay
Female
Hepatitis
HIV
HIV-1 - immunology
HIV-1 - metabolism
Human immunodeficiency virus
Humans
Immunity, Cellular - immunology
Immunity, Humoral - immunology
Immunization, Secondary - methods
Immunogenicity
Infectious diseases
Injection
Injections
Interferon
Lymphocytes T
Male
Medicine
Middle Aged
Peptide Fragments - metabolism
Priming
Safety
Safety regulations
Studies
Syringes
T cells
Vaccination
Vaccination - instrumentation
Vaccines
Vaccines, DNA - administration & dosage
Vaccines, DNA - adverse effects
Vaccines, DNA - genetics
Vaccines, DNA - immunology
Vice presidents (Organizations)
West Nile virus
Young Adult
γ-Interferon
United States > US
Maryland
Online AccessGet full text

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Abstract 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.
AbstractList DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO.sub.2 -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[TM] or needle and syringe (N/S) and boosted IM at week 24 with VRC-HIVADV014-00-VP (rAd5) with N/S at 10.sup.10 or 10.sup.11 particle units (PU). Equal numbers per assigned schedule had low ([less than or equal to]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-[gamma] 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-[gamma] ELISpot, CD8+ T-cell, and antibody responses after rAd5 boosting.
Background 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. 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® 2000™ or needle and syringe (N/S) and boosted IM at week 24 with VRC-HIVADV014-00-VP (rAd5) with N/S at 1010 or 1011 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-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. Conclusions 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. Trial Registration ClinicalTrials.gov NCT00109629
Background DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO.sub.2 -powered Biojector® 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® 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.sup.10 or 10.sup.11 particle units (PU). Equal numbers per assigned schedule had low ([less than or equal to]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® 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. Conclusions DNA vaccination by Biojector® 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
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.
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.
Background 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. 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® 2000™ or needle and syringe (N/S) and boosted IM at week 24 with VRC-HIVADV014-00-VP (rAd5) with N/S at 1010 or 1011 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-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. Conclusions 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. Trial Registration ClinicalTrials.gov NCT00109629
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.BACKGROUNDDNA 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.METHODSForty 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.RESULTS120 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.CONCLUSIONSDNA 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.TRIAL REGISTRATIONClinicalTrials.gov NCT00109629.
Audience Academic
Author Peel, Sheila A.
Gordon, Ingelise J.
Koup, Richard A.
Graham, Barney S.
Nason, Martha C.
Ledgerwood, Julie E.
Enama, Mary E.
Bailer, Robert T.
Plummer, Sarah A.
Mascola, John R.
Nabel, Gary J.
Roederer, Mario
AuthorAffiliation 2 Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America
3 Walter Reed Army Institute of Research, U.S. Military HIV Research Program, Silver Spring, Maryland, United States of America
1 Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America
Istituto Superiore di Sanità, Italy
AuthorAffiliation_xml – name: Istituto Superiore di Sanità, Italy
– name: 1 Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America
– name: 3 Walter Reed Army Institute of Research, U.S. Military HIV Research Program, Silver Spring, Maryland, United States of America
– name: 2 Biostatistics Research Branch, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/23577062$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Contributor Rucker, Steve
Eaton, Erica
Goswami, Trishna
Alley, Tiffany
Starling, Judith
Gomez, Phillip
McCluskey, Margaret
Casazza, Joseph
Catanzaro, Andrew
Sitar, Sandra
Novik, Laura
Sheets, Rebecca
Yan, Lihan
Edmonds, Pamela
Jones, Richard
DuBois, Woody
DeCederfelt, Hope
Holman, Lasonji
Thompson, Erica
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Rhone, Kathy
Stein, Judy
Larkin, Brenda
Andrews, Charla
Stanford, LaChonne
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Conceived and designed the experiments: BSG MEE MCN Sarah A Plummer JEL. Performed the experiments: BSG IJG Sarah A Plummer JEL Sheila A Peel JRM RTB MR RAK GJN. Analyzed the data: BSG, MCN, RAK GJN. Contributed reagents/materials/analysis tools: Sheila A Peel JRM RTB MR RK GJN.
Membership of the VRC 008 Study Team is provided in the Acknowledgments.
Competing Interests: GJN is named on patent applications for the candidate vaccines described in the paper. The patents include: 1) HIV vaccines based on Env of multiple clades of HIV, # 7666427; 2) HIV vaccines based on adenoviral vectors encoding Env from multiple clades of HIV, #8323961; 3) Method of using adenoviral vectors to induce an immune response, #WO2005110492; 4) Vaccines against AIDS comprising cmv/r-nucleic acid constructs, #WO2006020071. Lihan Yan and Phyllis Zaia (part of the VRC 008 Study Team) are employed by EMMES Corporation. There are no further patents, products in development or marketed products to declare. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials, as detailed online in the guide for authors.
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Snippet DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO2-powered Biojector® device was compared to delivery...
Background DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO.sub.2 -powered Biojector® device was...
DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO.sub.2 -powered Biojector® device was compared to...
Background DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO2-powered Biojector® device was compared...
Background DNA vaccine immunogenicity has been limited by inefficient delivery. Needle-free delivery of DNA using a CO2-powered Biojector® device was compared...
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StartPage e59340
SubjectTerms Adenoviridae - genetics
Adenoviruses
Adolescent
Adult
Adults
Antibodies, Viral - immunology
Avian flu
Binding sites
Biology
Carbon dioxide
CD4 antigen
CD8 antigen
CD8-Positive T-Lymphocytes - immunology
Clinical trials
Delivery scheduling
Deoxyribonucleic acid
DNA
DNA vaccines
DNA, Recombinant - genetics
Dose-Response Relationship, Immunologic
Drug delivery systems
Enzyme-linked immunosorbent assay
Female
Hepatitis
HIV
HIV-1 - immunology
HIV-1 - metabolism
Human immunodeficiency virus
Humans
Immunity, Cellular - immunology
Immunity, Humoral - immunology
Immunization, Secondary - methods
Immunogenicity
Infectious diseases
Injection
Injections
Interferon
Lymphocytes T
Male
Medicine
Middle Aged
Peptide Fragments - metabolism
Priming
Safety
Safety regulations
Studies
Syringes
T cells
Vaccination
Vaccination - instrumentation
Vaccines
Vaccines, DNA - administration & dosage
Vaccines, DNA - adverse effects
Vaccines, DNA - genetics
Vaccines, DNA - immunology
Vice presidents (Organizations)
West Nile virus
Young Adult
γ-Interferon
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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
URI https://www.ncbi.nlm.nih.gov/pubmed/23577062
https://www.proquest.com/docview/1330894549
https://www.proquest.com/docview/1326726164
https://pubmed.ncbi.nlm.nih.gov/PMC3620125
https://doaj.org/article/3b852a8c202e41198b2ecf9667a79776
http://dx.doi.org/10.1371/journal.pone.0059340
Volume 8
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