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EV01: A phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium

Abstract NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag , pol , env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and... Full description

Journal Title: Vaccine 2008, Vol.26 (25), p.3153-3161
Main Author: Bart, Pierre-Alexandre
Other Authors: Goodall, Ruth , Barber, Tristan , Harari, Alexandre , Guimaraes-Walker, Ana , Khonkarly, Mona , Sheppard, Neil C , Bangala, Yolanda , Frachette, Marie-Joelle , Wagner, Ralf , Liljeström, Peter , Kraehenbuhl, Jean-Pierre , Girard, Marc , Goudsmit, Jaap , Esteban, Mariano , Heeney, Jonathan , Sattentau, Quentin , McCormack, Sheena , Babiker, Abdel , Pantaleo, Giuseppe , Weber, Jonathan
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: Oxford: Elsevier Ltd
ID: ISSN: 0264-410X
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title: EV01: A phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium
format: Article
creator:
  • Bart, Pierre-Alexandre
  • Goodall, Ruth
  • Barber, Tristan
  • Harari, Alexandre
  • Guimaraes-Walker, Ana
  • Khonkarly, Mona
  • Sheppard, Neil C
  • Bangala, Yolanda
  • Frachette, Marie-Joelle
  • Wagner, Ralf
  • Liljeström, Peter
  • Kraehenbuhl, Jean-Pierre
  • Girard, Marc
  • Goudsmit, Jaap
  • Esteban, Mariano
  • Heeney, Jonathan
  • Sattentau, Quentin
  • McCormack, Sheena
  • Babiker, Abdel
  • Pantaleo, Giuseppe
  • Weber, Jonathan
subjects:
  • Adult
  • AIDS vaccines
  • AIDS Vaccines - administration & dosage
  • AIDS Vaccines - chemistry
  • AIDS Vaccines - immunology
  • Allergy and Immunology
  • Antithrombin III
  • Applied microbiology
  • Biological and medical sciences
  • Blood pressure
  • Clinical trials
  • Consortia
  • Female
  • Fundamental and applied biological sciences. Psychology
  • Good Manufacturing Practice
  • Hepatitis
  • HIV (Viruses)
  • HIV Infections - prevention & control
  • HIV preventative vaccine
  • HIV-1 - immunology
  • Human immunodeficiency virus
  • Humans
  • Immunization
  • Laboratories
  • Male
  • Medicin och hälsovetenskap
  • Microbiology
  • Middle Aged
  • Miscellaneous
  • NYVAC-C
  • Peptides - chemistry
  • Phase I
  • Product development
  • Vaccines
  • Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
  • Viral Vaccines - administration & dosage
  • Viral Vaccines - chemistry
  • Viral Vaccines - immunology
  • Viral Vaccines - therapeutic use
  • Virology
ispartof: Vaccine, 2008, Vol.26 (25), p.3153-3161
description: Abstract NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag , pol , env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and 4, and assessed for safety and immunogenicity over 48 weeks. There were no serious adverse events, and no clinical or laboratory abnormalities or other events that led to withdrawal, interruption or dose reduction of the NYVAC-C/placebo. Half of the 10 assessed responded in the ELISpot assay under stringent criteria, which informed the sample size for a DNA–NYVAC-C comparison to NYVAC-C alone.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0264-410X
fulltext: fulltext
issn:
  • 0264-410X
  • 1873-2518
url: Link


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titleEV01: A phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium
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creatorBart, Pierre-Alexandre ; Goodall, Ruth ; Barber, Tristan ; Harari, Alexandre ; Guimaraes-Walker, Ana ; Khonkarly, Mona ; Sheppard, Neil C ; Bangala, Yolanda ; Frachette, Marie-Joelle ; Wagner, Ralf ; Liljeström, Peter ; Kraehenbuhl, Jean-Pierre ; Girard, Marc ; Goudsmit, Jaap ; Esteban, Mariano ; Heeney, Jonathan ; Sattentau, Quentin ; McCormack, Sheena ; Babiker, Abdel ; Pantaleo, Giuseppe ; Weber, Jonathan
creatorcontribBart, Pierre-Alexandre ; Goodall, Ruth ; Barber, Tristan ; Harari, Alexandre ; Guimaraes-Walker, Ana ; Khonkarly, Mona ; Sheppard, Neil C ; Bangala, Yolanda ; Frachette, Marie-Joelle ; Wagner, Ralf ; Liljeström, Peter ; Kraehenbuhl, Jean-Pierre ; Girard, Marc ; Goudsmit, Jaap ; Esteban, Mariano ; Heeney, Jonathan ; Sattentau, Quentin ; McCormack, Sheena ; Babiker, Abdel ; Pantaleo, Giuseppe ; Weber, Jonathan ; EuroVacc Consortium
descriptionAbstract NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag , pol , env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and 4, and assessed for safety and immunogenicity over 48 weeks. There were no serious adverse events, and no clinical or laboratory abnormalities or other events that led to withdrawal, interruption or dose reduction of the NYVAC-C/placebo. Half of the 10 assessed responded in the ELISpot assay under stringent criteria, which informed the sample size for a DNA–NYVAC-C comparison to NYVAC-C alone.
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subjectAdult ; AIDS vaccines ; AIDS Vaccines - administration & dosage ; AIDS Vaccines - chemistry ; AIDS Vaccines - immunology ; Allergy and Immunology ; Antithrombin III ; Applied microbiology ; Biological and medical sciences ; Blood pressure ; Clinical trials ; Consortia ; Female ; Fundamental and applied biological sciences. Psychology ; Good Manufacturing Practice ; Hepatitis ; HIV (Viruses) ; HIV Infections - prevention & control ; HIV preventative vaccine ; HIV-1 - immunology ; Human immunodeficiency virus ; Humans ; Immunization ; Laboratories ; Male ; Medicin och hälsovetenskap ; Microbiology ; Middle Aged ; Miscellaneous ; NYVAC-C ; Peptides - chemistry ; Phase I ; Product development ; Vaccines ; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects) ; Viral Vaccines - administration & dosage ; Viral Vaccines - chemistry ; Viral Vaccines - immunology ; Viral Vaccines - therapeutic use ; Virology
ispartofVaccine, 2008, Vol.26 (25), p.3153-3161
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3Harari, Alexandre
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6Sheppard, Neil C
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8Frachette, Marie-Joelle
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12Girard, Marc
13Goudsmit, Jaap
14Esteban, Mariano
15Heeney, Jonathan
16Sattentau, Quentin
17McCormack, Sheena
18Babiker, Abdel
19Pantaleo, Giuseppe
20Weber, Jonathan
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0EV01: A phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium
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descriptionAbstract NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag , pol , env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and 4, and assessed for safety and immunogenicity over 48 weeks. There were no serious adverse events, and no clinical or laboratory abnormalities or other events that led to withdrawal, interruption or dose reduction of the NYVAC-C/placebo. Half of the 10 assessed responded in the ELISpot assay under stringent criteria, which informed the sample size for a DNA–NYVAC-C comparison to NYVAC-C alone.
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1AIDS vaccines
2AIDS Vaccines - administration & dosage
3AIDS Vaccines - chemistry
4AIDS Vaccines - immunology
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7Applied microbiology
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35Viral Vaccines - administration & dosage
36Viral Vaccines - chemistry
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38Viral Vaccines - therapeutic use
39Virology
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titleEV01: A phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium
authorBart, Pierre-Alexandre ; Goodall, Ruth ; Barber, Tristan ; Harari, Alexandre ; Guimaraes-Walker, Ana ; Khonkarly, Mona ; Sheppard, Neil C ; Bangala, Yolanda ; Frachette, Marie-Joelle ; Wagner, Ralf ; Liljeström, Peter ; Kraehenbuhl, Jean-Pierre ; Girard, Marc ; Goudsmit, Jaap ; Esteban, Mariano ; Heeney, Jonathan ; Sattentau, Quentin ; McCormack, Sheena ; Babiker, Abdel ; Pantaleo, Giuseppe ; Weber, Jonathan
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1AIDS vaccines
2AIDS Vaccines - administration & dosage
3AIDS Vaccines - chemistry
4AIDS Vaccines - immunology
5Allergy and Immunology
6Antithrombin III
7Applied microbiology
8Biological and medical sciences
9Blood pressure
10Clinical trials
11Consortia
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13Fundamental and applied biological sciences. Psychology
14Good Manufacturing Practice
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16HIV (Viruses)
17HIV Infections - prevention & control
18HIV preventative vaccine
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30Peptides - chemistry
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32Product development
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34Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects)
35Viral Vaccines - administration & dosage
36Viral Vaccines - chemistry
37Viral Vaccines - immunology
38Viral Vaccines - therapeutic use
39Virology
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14Esteban, Mariano
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17McCormack, Sheena
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0Bart, Pierre-Alexandre
1Goodall, Ruth
2Barber, Tristan
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7Bangala, Yolanda
8Frachette, Marie-Joelle
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13Goudsmit, Jaap
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15Heeney, Jonathan
16Sattentau, Quentin
17McCormack, Sheena
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atitleEV01: A phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium
jtitleVaccine
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risdate2008
volume26
issue25
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pages3153-3161
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abstractAbstract NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag , pol , env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and 4, and assessed for safety and immunogenicity over 48 weeks. There were no serious adverse events, and no clinical or laboratory abnormalities or other events that led to withdrawal, interruption or dose reduction of the NYVAC-C/placebo. Half of the 10 assessed responded in the ELISpot assay under stringent criteria, which informed the sample size for a DNA–NYVAC-C comparison to NYVAC-C alone.
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doi10.1016/j.vaccine.2008.03.083