Laboratory expansion to large-scale international HIV preventive vaccine trials
被引:13
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作者:
Gilmour, Jill W.
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机构:
Univ London Imperial Coll Sci Technol & Med, St Stephens Ctr, Chelsea & Westminster Hosp, Int AIDS Vaccine Initiat,Core Lab, London SW10 9NH, EnglandUniv London Imperial Coll Sci Technol & Med, St Stephens Ctr, Chelsea & Westminster Hosp, Int AIDS Vaccine Initiat,Core Lab, London SW10 9NH, England
Gilmour, Jill W.
[1
]
Stevens, Wendy S.
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机构:
Univ Witwatersrand, Dept Mol Med & Haematol, Johannesburg, South AfricaUniv London Imperial Coll Sci Technol & Med, St Stephens Ctr, Chelsea & Westminster Hosp, Int AIDS Vaccine Initiat,Core Lab, London SW10 9NH, England
Stevens, Wendy S.
[2
]
Gray, Clive
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机构:
Natl Inst Communicable Dis, Johannesburg, South AfricaUniv London Imperial Coll Sci Technol & Med, St Stephens Ctr, Chelsea & Westminster Hosp, Int AIDS Vaccine Initiat,Core Lab, London SW10 9NH, England
Gray, Clive
[3
]
de Souza, Mark
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机构:
AFRIMS Henry M Jackson Fdn, Dept Retrovirol, Bangkok, ThailandUniv London Imperial Coll Sci Technol & Med, St Stephens Ctr, Chelsea & Westminster Hosp, Int AIDS Vaccine Initiat,Core Lab, London SW10 9NH, England
de Souza, Mark
[4
]
机构:
[1] Univ London Imperial Coll Sci Technol & Med, St Stephens Ctr, Chelsea & Westminster Hosp, Int AIDS Vaccine Initiat,Core Lab, London SW10 9NH, England
[2] Univ Witwatersrand, Dept Mol Med & Haematol, Johannesburg, South Africa
[3] Natl Inst Communicable Dis, Johannesburg, South Africa
[4] AFRIMS Henry M Jackson Fdn, Dept Retrovirol, Bangkok, Thailand
AIDS vaccine trial;
good clinical laboratory practices;
standardization;
D O I:
10.1097/COH.0b013e3280eec77a
中图分类号:
R392 [医学免疫学];
Q939.91 [免疫学];
学科分类号:
100102 ;
摘要:
Purpose of review The purpose of this article is to describe the requirements for clinical laboratories supporting large-scale multinational trials of prophylactic AIDS vaccine trials and review the progress made. Recent findings There is an increasing need for laboratories in Africa, Asia and the Caribbean to support internationally initiated and funded clinical trials of preventive HIV vaccine candidates. A number of qualified laboratories are currently supporting AIDS vaccine trials in these regions, although there remains a need to develop capacity further. The standardization of all tests is key in order that data can be pooled and compared across multiple sites and products. Significant progress has been made towards this aim. The recent development of quality programmes including good clinical laboratory practices are key to ensuring data are reliable and meet the requirements of regulatory bodies. In addition, HIV diagnostic tests are being developed to distinguish true HIV infection from vaccine-induced antibodies. Summary Significant advances have been made to develop laboratories capable of supporting multinational AIDS vaccine trials.
机构:
Gyeongsang Natl Univ, Coll Vet Med, Jinju 52828, South Korea
Gyeongsang Natl Univ, Inst Anim Med, Jinju 52828, South KoreaGyeongsang Natl Univ, Coll Vet Med, Jinju 52828, South Korea
Nguyen, Binh T.
Yim, Dongjean
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Gyeongsang Natl Univ, Business Ctr, Hoxbio, Jinju 52828, South KoreaGyeongsang Natl Univ, Coll Vet Med, Jinju 52828, South Korea
Yim, Dongjean
Flores, Rochelle A.
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Gyeongsang Natl Univ, Coll Vet Med, Jinju 52828, South Korea
Gyeongsang Natl Univ, Inst Anim Med, Jinju 52828, South KoreaGyeongsang Natl Univ, Coll Vet Med, Jinju 52828, South Korea
Flores, Rochelle A.
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Lee, Seung Yun
Kim, Woo H.
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Gyeongsang Natl Univ, Coll Vet Med, Jinju 52828, South Korea
Gyeongsang Natl Univ, Inst Anim Med, Jinju 52828, South KoreaGyeongsang Natl Univ, Coll Vet Med, Jinju 52828, South Korea
Kim, Woo H.
Jung, Seung-Hwan
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机构:
MSD Anim Hlth Korea Ltd, Seoul Sq, Seoul 04637, South KoreaGyeongsang Natl Univ, Coll Vet Med, Jinju 52828, South Korea
Jung, Seung-Hwan
Kim, Sangkyu
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MSD Anim Hlth Korea Ltd, Seoul Sq, Seoul 04637, South KoreaGyeongsang Natl Univ, Coll Vet Med, Jinju 52828, South Korea
机构:
Univ Michigan, Sch Law, Ann Arbor, MI 48109 USA
Univ Copenhagen, Ctr Adv Studies Biomed Innovat Law, Copenhagen, DenmarkUniv Michigan, Sch Law, Ann Arbor, MI 48109 USA
Price, W. Nicholson, II
Rai, Arti K.
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机构:
Duke Univ, Sch Law, Durham, NC 27706 USA
Ctr Innovat Policy, Durham, NC 27706 USAUniv Michigan, Sch Law, Ann Arbor, MI 48109 USA
Rai, Arti K.
Minssen, Timo
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机构:
Univ Copenhagen, Ctr Adv Studies Biomed Innovat Law, Copenhagen, Denmark
Univ Copenhagen, Fac Law, Copenhagen, DenmarkUniv Michigan, Sch Law, Ann Arbor, MI 48109 USA
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Cornell Univ, Sch Operat Res & Informat Engn, 286 Rhodes Hall, Ithaca, NY 14853 USA
Cornell Univ, Cornell Inst Dis & Disaster Preparedness, 402 E 67th St, New York, NY 10065 USACornell Univ, Sch Operat Res & Informat Engn, 286 Rhodes Hall, Ithaca, NY 14853 USA
Muckstadt, John A.
Klein, Michael G.
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机构:
San Jose State Univ, Dept Mkt & Business Analyt, One Washington Sq, San Jose, CA 95192 USACornell Univ, Sch Operat Res & Informat Engn, 286 Rhodes Hall, Ithaca, NY 14853 USA
Klein, Michael G.
Jackson, Peter L.
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Singapore Univ Technol & Design, Engn Syst & Design, 8 Somapah Rd,Bldg 1,Level 7, Singapore 487372, Singapore
Weill Cornell Med, Dept Med, 530 East 70th St,M-522, New York, NY 10021 USACornell Univ, Sch Operat Res & Informat Engn, 286 Rhodes Hall, Ithaca, NY 14853 USA
Jackson, Peter L.
Gougelet, Robert M.
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Cornell Univ, Cornell Inst Dis & Disaster Preparedness, 402 E 67th St, New York, NY 10065 USACornell Univ, Sch Operat Res & Informat Engn, 286 Rhodes Hall, Ithaca, NY 14853 USA
Gougelet, Robert M.
Hupert, Nathaniel
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Cornell Univ, Cornell Inst Dis & Disaster Preparedness, 402 E 67th St, New York, NY 10065 USA
Weill Cornell Med, Dept Populat Hlth Sci, 402 E 67th St, New York, NY 10065 USACornell Univ, Sch Operat Res & Informat Engn, 286 Rhodes Hall, Ithaca, NY 14853 USA
机构:
Nanjing Univ, Dept Phys, Natl Lab Solid State Microstruct, Nanjing 210093, Peoples R China
Nanjing Univ, Chem & Biomed Innovat Ctr, Nanjing 210093, Peoples R China
Nanjing Univ, Inst Brain Sci, Nanjing 210093, Peoples R China
Nanjing Univ, Shenzhen Res Inst, Shenzhen 518057, Peoples R ChinaNanjing Univ, Dept Phys, Natl Lab Solid State Microstruct, Nanjing 210093, Peoples R China
Yin, Sheng
Cao, Yi
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机构:
Nanjing Univ, Dept Phys, Natl Lab Solid State Microstruct, Nanjing 210093, Peoples R China
Nanjing Univ, Chem & Biomed Innovat Ctr, Nanjing 210093, Peoples R China
Nanjing Univ, Inst Brain Sci, Nanjing 210093, Peoples R China
Nanjing Univ, Shenzhen Res Inst, Shenzhen 518057, Peoples R ChinaNanjing Univ, Dept Phys, Natl Lab Solid State Microstruct, Nanjing 210093, Peoples R China
机构:
Oslo Univ Hosp, Neurol, N-0424 Oslo, Norway
Norwegian Air Ambulance Fdn, Oslo, NorwayOslo Univ Hosp, Neurol, N-0424 Oslo, Norway
Sandset, Else Charlotte
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Walter, Silke
Song, Lili
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George Inst Global China, Beijing, Peoples R China
Univ New South Wales, George Inst Global Hlth, Fac Med, Sydney, NSW, AustraliaOslo Univ Hosp, Neurol, N-0424 Oslo, Norway