The Quality Assurance for Duke Vaccine Immunogenicity Programs (QADVIP) (Director: M. Sarzotti-Kelsoe) was originally created in 2002, under the name of Duke CFAR Central Quality Assurance Unit (CQAU), to implement a quality system for three HIV Vaccine Trials Network (HVTN) Endpoint Assay Laboratories.
Today, QADVIP oversees Good Clinical Laboratory Practice (GCLP) compliance by multiple laboratories (CFAR and non-CFAR affiliated) at Duke and outside of Duke involved in processing and the immunogenicity endpoint assessment of specimens from HIV, SARS CoV-2, influenza, malaria, and other vaccine phase I-III clinical trials.
QADVIP has expanded its operations within the CFAR community and with its strategic partners. This has involved monitoring/managing quality and establishing proficiency testing programs for multiple vaccine consortia associated with Duke CFAR, Collaboration for AIDS Vaccine Discovery (CAVD), Duke Center for Human Systems Immunology (CHSI), and Duke Human Vaccine Institute (DHVI) laboratories (EQAPOL, VQA, IQA). QADVIP also oversees quality implementation in laboratories conducting non HIV studies, such as the DHVI Accessioning Unit, DHVI Protein Production Facility, the Collaborative Influenza Vaccine Innovation Centers (CIVICs), the Substrate Services Core Research Support (SSCRS), the Surgical Critical Care Initiative (SC2i) and Mucosal Immunity in human Coronavirus Challenge (MUSICC) consortium.
ISO 17020 Accredited Services:
Audits and Monitoring
QADVIP performs facility, in-process, and data audits to ensure compliance to applicable regulations/guidance. An audit report detailing observations and findings is generated as a deliverable. QADVIP will then follow up with the laboratory with an audit report response form (corrective action plan) to set a timetable to compliance.
Quality Consultation
QADVIP has extensive experience advising on implementing quality into basic research and development laboratories. This typically involves an initial site visit of the laboratory with a report of observations and recommendations as follow-up.
Site Visits
QADVIP offers initial site visits to assess laboratory compliance to GCLP prior to their first audit. Visits include active discussions of current processes and recommendations on QMS software, document control, and other quality measures that can improve the GCLP quality of the lab.
Standard Services*:
Document Review/Management and Document Control
QADVIP can assist laboratories in the creation and implementation of Standard Operating Procedures, Study Plans, Final Reports, Method Qualification/Validation Protocols/Reports and other documents. QADVIP can also assist with document revision cycles and document control.
Assistance with Regulations/Guidance
QADVIP can assist the laboratory in the interpretation and application of various federal and international regulations/guidance necessary for compliance to Sponsor requirements, such as ISO 17043 (Proficiency Testing) and ISO 20387 (Biobanking).
GCLP Training
QADVIP can provide customized training on the applicable elements of Good Clinical Laboratory Practice as endorsed by the NIAID, RQA, and EMA.
Certificate of Analysis (COA) Review
QADVIP offers review services of raw data, submitted in conjunction with the associated COA’s providing QA signatory approvals, compliant with GCLP and ISO/IEC.
Method Validation**
QADVIP can assist laboratories with the formal processes of method qualification and validation following ICH Q2 (R1) and FDA guidance, through training in validation, overseeing quality implementation in the development of validation protocols, the conduction of validation assays, and the preparation of a validation final report.
*Standard services are not included under the scope of the ISO 17020:2012 accreditation.
**Examples of laboratory endpoint assays under quality assurance oversight: Binding Antibody Multiplex Assays (BAMA), Enzyme–linked immunosorbent assays (ELISA), Enzyme-linked ImmunoSpot (ELISPOT) Assays, Neutralizing Antibody (NAb) Assays, Antibody-dependent Cell-mediated Cytotoxicity Assays (ADCC), Intracellular Cytokine Staining Assays (ICS), Biolayer Interferometry (BLI)
Other Services:
QADVIP coordinates two annual mailings for the TZM-bl - Proficiency Testing Program (T-PTP). The T-PTP is supported by funding from the Collaboration of AIDS Vaccine Discovery (CAVD) and the National Institute of Allergy and Infectious Diseases (NIAID) and has been providing a proficiency testing platform for endpoint assay laboratories performing HIV Neutralizing Antibody (NAb) Assays in TZM-bl cells since 2006.
Program support is provided through a network of consortia, including vendors and qualified laboratories compliant to Good Clinical Laboratory Practice (GCLP), to provide a customized quality solution for NAb assay proficiency testing using a validated assay platform (Sarzotti-Kelsoe et al.). Each testing kit includes blinded reagents and Env-pseudotyped viruses that are used for assessment of a laboratory’s TZM-bl neutralization assay performance. For questions about this program, please contact the program via email at T-PTP@duke.edu.
In 2020 the QADVIP was accredited for compliance with the International Organization for Standardization (ISO) 17020:2012 as an Inspection Body, by ANAB and ILAC (cert. AI-2871). This standard provides guidance for inspection bodies, focusing on the ability to manage impartiality and conflicts of interest throughout the entire audit process. QADVIP is one of approximately five QA Departments of this type in the world to become accredited and recognized internationally as an ISO 17020 inspection body. QADVIP is also one of the first QA units to become ISO 17020 accredited within Academia.
Strengthening the Application of the DAIDS GCLP Guidelines: The Implementation of an Integrated Laboratory Oversight Framework
This publication details the “harmonization” efforts between NIAID GCLP and RQA GCLP, which was led by the CFAR CQAU (QADVIP).
This publication details the establishment of an international proficiency testing program for the Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells.
This publication details technology transfer of the Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells to an international network of laboratories operating under GCLP compliance.
This publication details the various steps of establishing an international quality assurance program to oversee the integrity of PBMCs’ collection and long-term storage.
This publication details the steps taken to implement GCLP in domestic laboratories previously operating in a research and development environment, as part of an NIH-funded contract.
These publications detail the validation efforts, with QADVIP quality oversight, for several methods and immunogenicity endpoint assays:
- Sarzotti-Kelsoe M, Daniell X, Todd CA, Bilska M, Martelli A, LaBranche C, Perez LG, Ochsenbauer C, Kappes JC, Rountree W, Denny TN, Montefiori DC, Optimization and validation of a neutralizing antibody assay for HIV-1 in A3R5 cells Kappes JC, Rountree W, Denny TN, Montefiori DC. J Immunol Methods. 2014 Jul; 409:147-60.
- Sarzotti-Kelsoe M, Bailer RT, Turk E, Lin C, Bilska M, Greene KM, Gao H, Todd CA, Ozaki DA, Seaman MS, Mascola JR, Montefiori DC, Optimization and validation of the TZM-bl assay for standardized assessments of neutralizing antibodies against HIV-1, J Immunol Methods. 2014 Jul; 409:131-46.
- Dennison SM, Reichartz M, Seaton KE, Dutta S, Wille-Reece U, Hill AVS, Ewer KJ, Rountree W, Sarzotti-Kelsoe M, Ozaki DA, Alam SM, Tomaras GD. Qualified Biolayer Interferometry Avidity Measurements Distinguish the Heterogeneity of Antibody Interactions with Plasmodium falciparum Circumsporozoite Protein Antigens. J Immunol. 2018 Aug 15; 201(4):1315-1326
- Schultz A, Germann A, Fuss M, Sarzotti-Kelsoe M, Ozaki DA, Montefiori DC, Zimmermann H, von Briesen H. Validation of an automated system for aliquoting of HIV-1 Env-pseudotyped virus stocks. PLoS One. 2018 Jan 4;13(1):e0190669. doi: 10.1371/journal.pone.0190669. eCollection 2018.
- Brown EP, Weiner JA, Lin S, Natarajan H, Normandin E, Barouch DH, Alter G, Sarzotti-Kelsoe M, Ackerman ME. Optimization and Qualification of an Fc Array Assay for Assessments of Antibodies Against HIV-1/SIV. J Immunol Methods. 2018 Apr;455:24-33. doi: 10.1016/j.jim.2018.01.013. Epub 2018 Jan 31.
- Seaman MS, Bilska M, Ghantous F, Eaton A, LaBranche CC, Greene K, Gao H, Weiner JA, Ackerman ME, Garber DA, Rosenberg YJ, Sarzotti-Kelsoe M, Montefiori DC. Optimization and qualification of a functional anti-drug antibody assay for HIV-1 bnAbs. J Immunol Methods. 2020 Jan, 112736; Epub 2020 Jan 7.
- Bharadwaj P, Riekofski C, Lin S, Seaman MS, Garber DA, Montefiori D, Sarzotti-Kelsoe M, Ackerman ME, Weiner JA. Implementation of a three-tiered approach to identify and characterize anti-drug antibodies raised against HIV-specific broadly neutralizing antibodies. J Immunol Methods. 2020 Feb 15:112764. doi: 10.1016/j.jim.2020.112764.
Conference Presentations
- Kelsey Hall, Kathy Yarborough, Zachary Korzen-Varin, Rebecca Beerman, Tom Denny, Marcella Sarzotti-Kelsoe. When to change and adopt a new Quality Standard: a case study with the Duke Human Vaccine Institute Protein Production Facility. Poster Presentation at HIV Vaccine Trials Network (HVTN) Full Group Meeting. Washington, D.C. 2024.
- Virtual Poster Presentation on same topic at Duke Health Quality and Safety Conference. Durham, NC. 2024. Duke community members can view the presentation: https://prodduke.sharepoint.com/sites/DUHS-DukeHSQ/SitePages/Virtual-Poster-Session.aspx
- Ariane Vinson, Zachary Korzen-Varin, Kelsey Hall, Marcella Sarzotti-Kelsoe. Archiving Procedures for GCLP Compliance. Poster Presentation at 2nd Annual CHSI Retreat. Durham, NC. 2024.
- Rebecca Beerman, Brian Boykin, Kelsey Hall, Marcella Sarzotti-Kelsoe. Electronic Quality Management Systems: Should you change systems? When? How? An Opportunity to Share Recommendations from our Recent Experience. Presentation at Society of Quality Assurance 40th Annual Meeting. Aurora, Colorado. 2024.
- R. Beerman was the 2024 recipient of the SQA Past President’s Scholarship Award
- Virtual Poster Presentation on same topic at Duke Health Quality and Safety Conference. Durham, NC. 2024 Duke community members can view the presentation: https://prodduke.sharepoint.com/sites/DUHS-DukeHSQ/SitePages/Virtual-Poster-Session.aspx
- Kristen Skinner. Bridging the Gap: GCLP to ISO 17043 Accreditation. Poster Presentation at HIV Vaccine Trials Network (HVTN) Full Group Meeting. Seattle, WA. 2023.
- Ariane Vinson, Zachary Korzen-Varin, Kelsey Hall, Marcella Sarzotti-Kelsoe. Organizing Physical Archives. Poster Presentation at HIV Vaccine Trials Network (HVTN) Full Group Meeting. Seattle, WA. 2023.
- Carley West, Robyn Osborne, Carmela Archual, Ariane Vinson, Raul Louzao, Angela McKenzie, Mary-Beth Joshi, Marcella Sarzotti-Kelsoe. A Quality Assurance Program for the Integrity of Peripheral Blood Mononuclear Cell Specimens Isolated and Stored by SSCRS for use in the 1,000 Patient Surgery Project (1KP) Poster/Oral Presentation at Surgical Critical Care Initiative (SC2i) Investigators Meeting. Washington, D.C. 2023
Quality Assurance for Duke Vaccine Immunogenicity Programs
2812 Erwin Rd. Erwin Terrace II
Ste. 301
Durham, NC 27705
qadvip@duke.edu
Marcella Sarzotti-Kelsoe, Ph.D.
Director, QADVIP
See short Biography in Immunology Core Leadership
Integrative Immunobiology Women's Month History Profile
marcellakelsoe@dm.duke.edu
Angela McKenzie
Scientific Program Leader
Angela McKenzie is a Scientific Program Leader with the Quality Assurance of Duke Vaccine Immunogenicity Programs (QADVIP) at Duke University. She brings to the team over 18 years of research experience working for Pharmaceutical, CRO’s and academic laboratories. Angela joined the team in February 2017 and manages the QADVIP portfolio, overseeing new and ongoing programs, financial administration, and personnel oversight.
angela.mckenzie@duke.edu
Rebecca Beerman, Ph.D.
Systems Compliance Manager
Rebecca Beerman joined the QADVIP in October 2020, supporting electronic data management, data audits, and computer systems validation initiatives for all of the clinical research programs under QADVIP oversight. Rebecca’s Duke career started in 2011, as a postdoctoral researcher in the department of Molecular Genetics and Microbiology. In 2017, she joined the newly established Duke Office of Scientific Integrity – ASIST team, helping to develop and implement several research integrity programs and software/data management tools. Rebecca holds a B.S. in Molecular Biology from the University of Pittsburgh and a Ph.D. in Cell and Molecular Biology from the University of Pennsylvania.
rebecca.beerman@duke.edu
Kristen Skinner
QA & Regulatory Compliance Associate
Kristen Skinner joined Duke University in 2017 and serves as the QA and Regulatory Compliance Associate at QADVIP, where she holds Quality Manager Roles for ISO 17020, ISO 20387 and ISO 17043 accreditations for numerous NIAID and Gates funded research programs and biorepositories. With over a decade of experience in CAP accredited clinical laboratories, Kristen has dedicated the last seven years to Quality Assurance with GCLP oversight. Kristen also serves as the audit program manager for all sites under QADVIP oversight.
https://www.linkedin.com/in/kristenskinner/
kristen.skinner@duke.edu
Zachary Korzen-Varin
Senior Coordinator, QA & Compliance
Zachary graduated from NCSU with a B.S. in Microbiology. He previously worked in an HIV research laboratory at Duke. In his downtime, he enjoys bird watching and rock climbing with his wife.
zachary.varin@duke.edu
Kelsey Hall, MBA
Senior Coordinator, QA & Compliance
Kelsey received her Bachelor’s degree in Biological Sciences from the University of North Carolina (UNC) at Charlotte and a Master’s in Business Administration with a concentration in Information Systems Management from UNC Wilmington. Her previous technical experience in the ADCC lab allowed for a seamless transition to a regulatory career as a Coordinator for Quality Assurance and Compliance within QADVIP, where she advanced to an internal Senior position. Within the QADVIP, Kelsey has become familiar with aspects of regulatory document management and auditing, while maintaining a respectful, customer service focused attitude to promote the highest quality of research in keeping with GCLP guidelines. Kelsey will assist with the BAMA and NAb laboratories, and coordinate the TZM-bl – Proficiency Testing Program.
kelsey.hall@duke.edu
Carley West
Coordinator, QA & Compliance
Carley joined QADVIP in 2022 as a Coordinator for QA and Compliance. She began her career at Duke in HIV, and later SARS-CoV-2, vaccine research. She has a lifelong interest in the development of an effective HIV vaccine and hopes to facilitate support through quality assurance. Within QADVIP, Carley works closely with labs to facilitate ongoing compliance to DAIDS GCLP standards and provide support services. Outside of work, she enjoys painting and watching reality TV.
carley.west@duke.edu
Amanda Parrish
Coordinator, QA & Compliance
Amanda graduated with a B.S. in Biology from East Carolina in 2014. Her first job was in a microbiology lab, where she performed testing on dietary supplements and cosmetics. In 2017, Amanda started working for the North Carolina State Laboratory of Public Health, where she worked in the Newborn Screening department and conducted time-sensitive testing. Amanda spends her spare time with family and visiting the coast and mountains.
amanda.parrish@duke.edu
Ariane Vinson, Ph.D.
QA Project Coordinator
Ariane Vinson joined the QADVIP in July 2022. Before that, she taught chemistry, biology, and TEAS prep courses for 11 years at community colleges in Durham and Alamance counties. She received her B.A. in chemistry with a biology minor from Wellesley College and her Ph.D. from Wake Forest University.
ariane.vinson@duke.edu
Spring 2021
- In support of these updated guidelines, DAIDS has developed new GCLP online training, now required for all compliant network participants under QADVIP’s quality assurance umbrella. Contact your lab’s quality manager or qadvip@duke.edu for more information on how to access this training.
- Surgical Sciences Quality Assurance Unit awarded Researchers of the Month!
Click here for the article from the "Good News from the Section - March 2021" newsletter.
Spring 2020
- In May 2020, QADVIP was notified that its quality oversight of the NAb assays would be required in support of the federal government's "Operation Warp Speed" program that was seeking to have a vaccine against SARS-CoV-2 available by year's end.