Sarzotti-Kelsoe, MarcellaNeedham, Leila KRountree, WesBainbridge, JohnGray, Clive MFiscus, Susan AFerrari, GuidoStevens, Wendy SStager, Susan LBinz, WhitneyLouzao, RaulLong, Kristy OMokgotho, PaulineMoodley, NiranjiniMackay, MelanieKerkau, MelissaMcMillion, TakeshaKirchherr, JenniferSoderberg, Kelly AHaynes, Barton FDenny, Thomas N2017-06-012017-06-012014-07https://hdl.handle.net/10161/14681The 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.BiorepositoryCryopreservationHIVHuman clinical trialsPBMCVaccineAIDS VaccinesAfricaCell SurvivalClinical Trials as TopicConsensusCooperative BehaviorCryopreservationGuideline AdherenceHIV InfectionsHumansImmunologic TestsInternational CooperationLaboratoriesLaboratory Proficiency TestingLeukocytes, MononuclearLongitudinal StudiesMonitoring, ImmunologicObserver VariationPractice Guidelines as TopicPredictive Value of TestsProgram DevelopmentProgram EvaluationQuality ControlReproducibility of ResultsSpecimen HandlingTime FactorsTreatment OutcomeUnited StatesWorkflowJournal article1872-7905