The Center for HIV/AIDS Vaccine Immunology (CHAVI) multi-site quality assurance program for cryopreserved human peripheral blood mononuclear cells.

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Sarzotti-Kelsoe, Marcella

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Needham, Leila K

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Rountree, Wes

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Bainbridge, John

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Gray, Clive M

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Fiscus, Susan A

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Ferrari, Guido

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Stevens, Wendy S

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Stager, Susan L

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Binz, Whitney

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Louzao, Raul

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Long, Kristy O

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Mokgotho, Pauline

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Moodley, Niranjini

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Mackay, Melanie

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Kerkau, Melissa

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McMillion, Takesha

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Kirchherr, Jennifer

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Soderberg, Kelly A

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Haynes, Barton F

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Denny, Thomas N

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Netherlands

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2017-06-01T19:18:14Z

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2017-06-01T19:18:14Z

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2014-07

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The Center for HIV/AIDS Vaccine Immunology (CHAVI) consortium was established to determine the host and virus factors associated with HIV transmission, infection and containment of virus replication, with the goal of advancing the development of an HIV protective vaccine. Studies to meet this goal required the use of cryopreserved Peripheral Blood Mononuclear Cell (PBMC) specimens, and therefore it was imperative that a quality assurance (QA) oversight program be developed to monitor PBMC samples obtained from study participants at multiple international sites. Nine site-affiliated laboratories in Africa and the USA collected and processed PBMCs, and cryopreserved PBMC were shipped to CHAVI repositories in Africa and the USA for long-term storage. A three-stage program was designed, based on Good Clinical Laboratory Practices (GCLP), to monitor PBMC integrity at each step of this process. The first stage evaluated the integrity of fresh PBMCs for initial viability, overall yield, and processing time at the site-affiliated laboratories (Stage 1); for the second stage, the repositories determined post-thaw viability and cell recovery of cryopreserved PBMC, received from the site-affiliated laboratories (Stage 2); the third stage assessed the long-term specimen storage at each repository (Stage 3). Overall, the CHAVI PBMC QA oversight program results highlight the relative importance of each of these stages to the ultimate goal of preserving specimen integrity from peripheral blood collection to long-term repository storage.

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https://www.ncbi.nlm.nih.gov/pubmed/24910414

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S0022-1759(14)00175-6

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1872-7905

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https://hdl.handle.net/10161/14681

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eng

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Elsevier BV

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J Immunol Methods

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10.1016/j.jim.2014.05.013

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Biorepository

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Cryopreservation

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HIV

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Human clinical trials

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PBMC

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Vaccine

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AIDS Vaccines

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Africa

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Cell Survival

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Clinical Trials as Topic

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Consensus

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Cooperative Behavior

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Cryopreservation

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Guideline Adherence

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HIV Infections

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Humans

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Immunologic Tests

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International Cooperation

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Laboratories

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Laboratory Proficiency Testing

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Leukocytes, Mononuclear

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Longitudinal Studies

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Monitoring, Immunologic

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Observer Variation

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Practice Guidelines as Topic

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Predictive Value of Tests

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Program Development

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Program Evaluation

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Quality Control

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Reproducibility of Results

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Specimen Handling

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Time Factors

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Treatment Outcome

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United States

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Workflow

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The Center for HIV/AIDS Vaccine Immunology (CHAVI) multi-site quality assurance program for cryopreserved human peripheral blood mononuclear cells.

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Journal article

pubs.author-url

https://www.ncbi.nlm.nih.gov/pubmed/24910414

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21

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30

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Basic Science Departments

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Clinical Science Departments

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Duke

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Duke Cancer Institute

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Duke Human Vaccine Institute

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Immunology

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Institutes and Centers

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Medicine

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Medicine, Duke Human Vaccine Institute

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Molecular Genetics and Microbiology

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School of Medicine

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Surgery

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Surgery, Surgical Sciences

pubs.publication-status

Published

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409

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