Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial

Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME100). The study was an open-label, dose-esc...

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Published inVaccine Vol. 29; no. 5; pp. 960 - 968
Main Authors Beckett, Charmagne G., Tjaden, Jeffrey, Burgess, Timothy, Danko, Janine R., Tamminga, Cindy, Simmons, Monika, Wu, Shuenn-Jue, Sun, Peifang, Kochel, Tadeusz, Raviprakash, Kanakatte, Hayes, Curtis G., Porter, Kevin R.
Format Journal Article
LanguageEnglish
Published Kidlington Elsevier Ltd 29.01.2011
Elsevier
Elsevier Limited
Subjects
Adolescent
Adult
adults
Allergy and Immunology
Antibodies, Neutralizing - blood
Antibodies, Viral - blood
Applied microbiology
Biological and medical sciences
Clinical trials
Dengue
Dengue - prevention & control
Dengue fever
Dengue Vaccines - administration & dosage
Dengue Vaccines - adverse effects
Dengue Vaccines - immunology
Dengue virus
Deoxyribonucleic acid
DNA
DNA vaccines
Enzymes
Fundamental and applied biological sciences. Psychology
genes
Health care
Human subjects
Humans
immune response
Immunization, Secondary - methods
Immunogenicity
Injections, Intramuscular
interferon-gamma
Microbiology
Middle Aged
muscles
neutralizing antibodies
Pain
Pain - chemically induced
plasmid vectors
recombinant vaccines
Safety
serotypes
Skin Diseases - chemically induced
T-lymphocytes
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Vaccines, DNA - administration & dosage
Vaccines, DNA - adverse effects
Vaccines, DNA - immunology
Vector-borne diseases
Young Adult
Clinical trials
Dengue
DNA vaccines
Infection
Viral disease
Arbovirus disease
Dengue 1
Clinical trial
Genetic vaccine
Online AccessGet full text

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Abstract Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME100). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naïve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0mg, n=12) or a low dose (1.0mg, n=10) DNA vaccine using the needle-free Biojector® 2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.
AbstractList Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME100). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naïve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0mg,n=12) or a low dose (1.0mg,n=10) DNA vaccine using the needle-free Biojector®2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.
Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME(100)). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naïve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0mg, n=12) or a low dose (1.0mg, n=10) DNA vaccine using the needle-free Biojector(®) 2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME(100)). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naïve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0mg, n=12) or a low dose (1.0mg, n=10) DNA vaccine using the needle-free Biojector(®) 2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.
Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME¹⁰⁰). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naïve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0mg, n=12) or a low dose (1.0mg, n=10) DNA vaccine using the needle-free Biojector® 2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.
Abstract Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME100 ). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naïve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0 mg, n = 12) or a low dose (1.0 mg, n = 10) DNA vaccine using the needle-free Biojector® 2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.
Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME(100)). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naïve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0mg, n=12) or a low dose (1.0mg, n=10) DNA vaccine using the needle-free Biojector(®) 2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.
Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME100). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naïve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0mg, n=12) or a low dose (1.0mg, n=10) DNA vaccine using the needle-free Biojector® 2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.
Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase 1 clinical trial was performed using the dengue virus serotype-1 (DENV-1) vaccine construct (D1ME[super]100). The study was an open-label, dose-escalation, safety and immunogenicity trial involving 22 healthy flavivirus-naieve adults assigned to one of two groups. Each group received three intramuscular injections (0, 1, and 5 months) of either a high dose (5.0 mg, n = 12) or a low dose (1.0 mg, n = 10) DNA vaccine using the needle-free Biojector[super][registered] 2000. The most commonly reported solicited signs and symptoms were local mild pain or tenderness (10/22, 45%), local mild swelling (6/22, 27%), muscle pain (6/22, 27%) and fatigue (6/22, 27%). Five subjects (41.6%) in the high dose group and none in the low dose group developed detectable anti-dengue neutralizing antibodies. T-cell IFN gamma responses were detected in 50% (4/8) and 83.3% (10/12) of subjects in the low and high dose groups, respectively. The safety profile of the DENV-1 DNA vaccine is acceptable at both doses administered in the study. These results demonstrate a favorable reactogenicity and safety profile of the first in human evaluation of a DENV-1 DNA vaccine.
Author Wu, Shuenn-Jue
Kochel, Tadeusz
Tjaden, Jeffrey
Sun, Peifang
Raviprakash, Kanakatte
Porter, Kevin R.
Hayes, Curtis G.
Tamminga, Cindy
Simmons, Monika
Danko, Janine R.
Beckett, Charmagne G.
Burgess, Timothy
Author_xml – sequence: 1
  givenname: Charmagne G.
  surname: Beckett
  fullname: Beckett, Charmagne G.
  email: charmagne.beckett@med.navy.mil
– sequence: 2
  givenname: Jeffrey
  surname: Tjaden
  fullname: Tjaden, Jeffrey
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  givenname: Timothy
  surname: Burgess
  fullname: Burgess, Timothy
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  givenname: Janine R.
  surname: Danko
  fullname: Danko, Janine R.
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  givenname: Cindy
  surname: Tamminga
  fullname: Tamminga, Cindy
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  givenname: Monika
  surname: Simmons
  fullname: Simmons, Monika
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  givenname: Shuenn-Jue
  surname: Wu
  fullname: Wu, Shuenn-Jue
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  surname: Sun
  fullname: Sun, Peifang
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  givenname: Tadeusz
  surname: Kochel
  fullname: Kochel, Tadeusz
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  surname: Raviprakash
  fullname: Raviprakash, Kanakatte
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  givenname: Curtis G.
  surname: Hayes
  fullname: Hayes, Curtis G.
– sequence: 12
  givenname: Kevin R.
  surname: Porter
  fullname: Porter, Kevin R.
BackLink http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23850504$$DView record in Pascal Francis
https://www.ncbi.nlm.nih.gov/pubmed/21111785$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Copyright 2010
2015 INIST-CNRS
Copyright © 2010 Elsevier Ltd. All rights reserved.
Copyright Elsevier Limited Jan 29, 2011
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Issue 5
Keywords Clinical trials
Dengue
DNA vaccines
Infection
Viral disease
Arbovirus disease
Dengue 1
Clinical trial
Genetic vaccine
Language English
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Snippet Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid vector. A Phase...
Abstract Candidate dengue DNA vaccine constructs for each dengue serotype were developed by incorporating pre-membrane and envelope genes into a plasmid...
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SubjectTerms Adolescent
Adult
adults
Allergy and Immunology
Antibodies, Neutralizing - blood
Antibodies, Viral - blood
Applied microbiology
Biological and medical sciences
Clinical trials
Dengue
Dengue - prevention & control
Dengue fever
Dengue Vaccines - administration & dosage
Dengue Vaccines - adverse effects
Dengue Vaccines - immunology
Dengue virus
Deoxyribonucleic acid
DNA
DNA vaccines
Enzymes
Fundamental and applied biological sciences. Psychology
genes
Health care
Human subjects
Humans
immune response
Immunization, Secondary - methods
Immunogenicity
Injections, Intramuscular
interferon-gamma
Microbiology
Middle Aged
muscles
neutralizing antibodies
Pain
Pain - chemically induced
plasmid vectors
recombinant vaccines
Safety
serotypes
Skin Diseases - chemically induced
T-lymphocytes
Vaccines
Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
Vaccines, DNA - administration & dosage
Vaccines, DNA - adverse effects
Vaccines, DNA - immunology
Vector-borne diseases
Young Adult
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Title Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial
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