The overall goal of our HVTN Laboratory Program is to conduct state-of-the-art laboratory-based clinical research and evaluation through the HIV Vaccine Trials Network that will lead to the development of a safe and efficacious HIV vaccine. To accomplish this goal, we propose six Specific Aims.
In Aim 1, we will build upon, improve and enrich the current infrastructure and operations of the HVTN Laboratory Program to provide the leadership and administration to conduct high quality laboratory-based vaccine research and evaluation.
In Aim 2, we will execute protocol-related validated endpoint laboratory studies in a GLP setting and comprehensive exploratory studies that will provide unambiguous measurements of vaccine immunogenicity.
In Aim 3, we will apply FDA-compliant, validated assays as well as a broad range of innovative approaches to measure vaccine efficacy in large-scale phase lib/Nil trials and to improve understanding of the correlates of HIV protection.
In Aim 4, we will explore strategies to induce and improve measurements of innate and mucosal immunity as well as anti-vaccine responses that have the potential to augment or dampen vaccine efficacy. We propose in Aim 5 a rigorous Laboratory QA/QC and operations program overarching all aspects of the HVTN Laboratory studies. Finally, in Aim 6 we will provide leadership and expertise as needed to facilitate and participate in investigations with other HIV clinical trials networks. Headquartered at FHCRC, the HVTN laboratory Program will coordinate its activities seamlessly with the HVTN Core Leadership and the SDAC (SCHARP) and with the DAIDS Vaccine Clinical Branch.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-TH-A (J1))
Program Officer
D'Souza, Patricia D
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Fred Hutchinson Cancer Research Center
United States
Zip Code
Cumberland, William N; Fong, Youyi; Yu, Xuesong et al. (2015) Nonlinear Calibration Model Choice between the Four and Five-Parameter Logistic Models. J Biopharm Stat 25:972-83
Ducar, Constance; Smith, Donna; Pinzon, Cris et al. (2014) Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal. J Immunol Methods 409:9-20
Seaton, Kelly E; Ballweber, Lamar; Lan, Audrey et al. (2014) HIV-1 specific IgA detected in vaginal secretions of HIV uninfected women participating in a microbicide trial in Southern Africa are primarily directed toward gp120 and gp140 specificities. PLoS One 9:e101863
Goepfert, Paul A; Elizaga, Marnie L; Seaton, Kelly et al. (2014) Specificity and 6-month durability of immune responses induced by DNA and recombinant modified vaccinia Ankara vaccines expressing HIV-1 virus-like particles. J Infect Dis 210:99-110
Gartland, Andrew J; Li, Sue; McNevin, John et al. (2014) Analysis of HLA A*02 association with vaccine efficacy in the RV144 HIV-1 vaccine trial. J Virol 88:8242-55
Finak, Greg; Frelinger, Jacob; Jiang, Wenxin et al. (2014) OpenCyto: an open source infrastructure for scalable, robust, reproducible, and automated, end-to-end flow cytometry data analysis. PLoS Comput Biol 10:e1003806
Sunshine, Justine; Kim, Moon; Carlson, Jonathan M et al. (2014) Increased sequence coverage through combined targeting of variant and conserved epitopes correlates with control of HIV replication. J Virol 88:1354-65
Slichter, Chloe K; Friedrich, David P; Smith, Rebecca J et al. (2014) Measuring inhibition of HIV replication by ex vivo CD8? T cells. J Immunol Methods 404:71-80
Li, Shuying S; Gilbert, Peter B; Tomaras, Georgia D et al. (2014) FCGR2C polymorphisms associate with HIV-1 vaccine protection in RV144 trial. J Clin Invest 124:3879-90
Finak, Greg; Jiang, Wenxin; Krouse, Kevin et al. (2014) High-throughput flow cytometry data normalization for clinical trials. Cytometry A 85:277-86

Showing the most recent 10 out of 25 publications