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Marcella Sarzotti-Kelsoe

Research Professor of Integrative Immunobiology
Integrative Immunobiology
DUMC Box 102800, Durham, NC 27710
2 Genome Ct., Msrbii Rm 1089, Durham, NC 27710

Overview


Ongoing Applied Activities 
•I direct a Global Quality Assurance Program, which I developed and pioneered here at Duke University, to oversee compliance with Good Clinical Laboratory Practice Guidelines in three HIV vaccine trial networks (CHAVI, CAVD, Duke HVTN, EQAPOL, Duke VTEU) involving domestic and international laboratory sites.
•I also direct a Global Proficiency Testing Program for laboratories testing for neutralizing antibody function in individuals infected with HIV or vaccinated against HIV. The Program was launched in 2009.
•I provide assistance and oversight for endpoint assay standardization, qualification and validation, as well as for the QSU of the GMP facility at DHVI, which will manufacture HIV vaccine products for first-in-man Phase I trials.

Past Basic Research
•Development of T cell responses in neonates.
•Neonatal T cell receptor Vβ repertoire diversity in the peripheral T cell pool.
•The role of heat shock protein, as a natural adjuvant, at eliciting innate and adaptive immune responses.
•Development of the T cell receptor repertoire in naïve, immunodeficient infants, given bone marrow or thymic transplantation.
•Thymic output, T cell diversity and T cell function in long-term human SCID chimeras.
•Telomere length in T cells from SCID chimeras.

Current Appointments & Affiliations


Research Professor of Integrative Immunobiology · 2013 - Present Integrative Immunobiology, Basic Science Departments
Associate Professor in Surgery · 2020 - Present Surgery, Clinical Science Departments
Member of the Duke Human Vaccine Institute · 2006 - Present Duke Human Vaccine Institute, Institutes and Centers

Recent Publications


Strengthening the Application of the DAIDS GCLP Guidelines: The Implementation of an Integrated Laboratory Oversight Framework.

Journal Article AIDS Res Hum Retroviruses · November 2024 The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability ... Full text Link to item Cite

Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.

Journal Article Science · January 7, 2022 In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at the time o ... Full text Link to item Cite

Calibration of two validated SARS-CoV-2 pseudovirus neutralization assays for COVID-19 vaccine evaluation.

Journal Article Sci Rep · December 14, 2021 Vaccine-induced neutralizing antibodies (nAbs) are key biomarkers considered to be associated with vaccine efficacy. In United States government-sponsored phase 3 efficacy trials of COVID-19 vaccines, nAbs are measured by two different validated pseudoviru ... Full text Link to item Cite
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Recent Grants


External Quality Assurance Program Oversight Laboratory (EQAPOL)

ResearchInvestigator · Awarded by National Institutes of Health · 2024 - 2031

CEPI QAU

ResearchPrincipal Investigator · Awarded by Imperial College London · 2025 - 2029

Neutralizing Antibody Assessment to Support bnAb Production

ResearchDirector · Awarded by Advanced Bioscience Laboratories, Inc. · 2024 - 2028

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Education, Training & Certifications


University of Turin (Italy) · 1986 D.R.
University of Turin (Italy) · 1980 Ph.D.