title: The Center for HIV/AIDS Vaccine Immunology (CHAVI) multi-site quality assurance program for cryopreserved human peripheral blood mononuclear cells.
abstract: 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.
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA; Department of Surgery, Duke University Medical Center, Durham, NC, USA; Department of Immunology, Duke University Medical Center, Durham, NC, USA. Electronic address: marcella.sarzottikelsoe@dm.duke.edu.
authors.forename: Marcella
authors.initials: M
authors.lastname: Sarzotti-Kelsoe
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Leila K
authors.initials: LK
authors.lastname: Needham
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Wes
authors.initials: W
authors.lastname: Rountree
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: John
authors.initials: J
authors.lastname: Bainbridge
authors.affiliation: AIDS Virus Research Unit, National Institute for Communicable Diseases, Johannesburg, South Africa.
authors.forename: Clive M
authors.initials: CM
authors.lastname: Gray
authors.affiliation: Department of Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Susan A
authors.initials: SA
authors.lastname: Fiscus
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA; Department of Surgery, Duke University Medical Center, Durham, NC, USA.
authors.forename: Guido
authors.initials: G
authors.lastname: Ferrari
authors.affiliation: Department of Molecular Medicine and Haematology, Faculty of Health Sciences, University of the Witwatersrand and the National Health Laboratory Services, Johannesburg, South Africa; Clinical Laboratory Services (CLS), Johannesburg, South Africa.
authors.forename: Wendy S
authors.initials: WS
authors.lastname: Stevens
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA; Department of Surgery, Duke University Medical Center, Durham, NC, USA.
authors.forename: Susan L
authors.initials: SL
authors.lastname: Stager
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Whitney
authors.initials: W
authors.lastname: Binz
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Raul
authors.initials: R
authors.lastname: Louzao
authors.affiliation: Department of Surgery, Duke University Medical Center, Durham, NC, USA.
authors.forename: Kristy O
authors.initials: KO
authors.lastname: Long
authors.affiliation: AIDS Virus Research Unit, National Institute for Communicable Diseases, Johannesburg, South Africa.
authors.forename: Pauline
authors.initials: P
authors.lastname: Mokgotho
authors.affiliation: AIDS Virus Research Unit, National Institute for Communicable Diseases, Johannesburg, South Africa; Clinical Laboratory Services (CLS), Johannesburg, South Africa.
authors.forename: Niranjini
authors.initials: N
authors.lastname: Moodley
authors.affiliation: AIDS Virus Research Unit, National Institute for Communicable Diseases, Johannesburg, South Africa; Clinical Laboratory Services (CLS), Johannesburg, South Africa.
authors.forename: Melanie
authors.initials: M
authors.lastname: Mackay
authors.affiliation: Department of Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Melissa
authors.initials: M
authors.lastname: Kerkau
authors.affiliation: Department of Microbiology and Immunology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Takesha
authors.initials: T
authors.lastname: McMillion
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Kirchherr
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Kelly A
authors.initials: KA
authors.lastname: Soderberg
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Barton F
authors.initials: BF
authors.lastname: Haynes
authors.affiliation: Duke Human Vaccine Institute, Duke University Medical Center, Durham, NC, USA.
authors.forename: Thomas N
authors.initials: TN
authors.lastname: Denny
mesh_terms: D016915:AIDS Vaccines / Q000627:therapeutic use*; D000349:Africa; D002470:Cell Survival; D002986:Clinical Trials as Topic / Q000592:standards*; D032921:Consensus; D003299:Cooperative Behavior; D015925:Cryopreservation / Q000592:standards*; D019983:Guideline Adherence / Q000592:standards; D015658:HIV Infections / Q000175:diagnosis / Q000276:immunology / Q000628:therapy* / Q000821:virology; D006801:Humans; D007159:Immunologic Tests / Q000592:standards*; D007391:International Cooperation; D007753:Laboratories / Q000592:standards*; D059021:Laboratory Proficiency Testing / Q000592:standards*; D007963:Leukocytes, Mononuclear / Q000276:immunology* / Q000821:virology; D008137:Longitudinal Studies; D015166:Monitoring, Immunologic / Q000592:standards*; D015588:Observer Variation; D017410:Practice Guidelines as Topic / Q000592:standards; D011237:Predictive Value of Tests; D016730:Program Development; D015397:Program Evaluation; D011786:Quality Control; D015203:Reproducibility of Results; D013048:Specimen Handling / Q000592:standards*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D057188:Workflow
chemical_list: D016915:AIDS Vaccines
keywords: Biorepository; Cryopreservation; HIV; Human clinical trials; PBMC; Vaccine