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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
3UM1AI068618-07S1
Application #
8645799
Study Section
Special Emphasis Panel (ZAI1-TH-A (J1))
Program Officer
D'Souza, Patricia D
Project Start
2006-06-29
Project End
2013-12-31
Budget Start
2013-06-01
Budget End
2013-12-31
Support Year
7
Fiscal Year
2013
Total Cost
$7,256,662
Indirect Cost
$1,876,680
Name
Fred Hutchinson Cancer Research Center
Department
Type
DUNS #
078200995
City
Seattle
State
WA
Country
United States
Zip Code
98109
Stekler, Joanne D; Ure, George; O'Neal, Joshua D et al. (2016) Performance of Determine Combo and other point-of-care HIV tests among Seattle MSM. J Clin Virol 76:8-13
Hughes, Sean M; Shu, Zhiquan; Levy, Claire N et al. (2016) Cryopreservation of Human Mucosal Leukocytes. PLoS One 11:e0156293
Fong, Youyi; Yin, Shuxin; Huang, Ying (2016) Combining biomarkers linearly and nonlinearly for classification using the area under the ROC curve. Stat Med 35:3792-809
Lama, Javier R; Karuna, Shelly T; Grant, Shannon P et al. (2016) Transient Peripheral Immune Activation follows Elective Sigmoidoscopy or Circumcision in a Cohort Study of MSM at Risk of HIV Infection. PLoS One 11:e0160487
Gray, Glenda E; Mayer, Kenneth H; Elizaga, Marnie L et al. (2016) Subtype C gp140 Vaccine Boosts Immune Responses Primed by the South African AIDS Vaccine Initiative DNA-C2 and MVA-C HIV Vaccines after More than a 2-Year Gap. Clin Vaccine Immunol 23:496-506
Lhomme, Edouard; Richert, Laura; Moodie, Zoe et al. (2016) Early CD4+ T Cell Responses Are Associated with Subsequent CD8+ T Cell Responses to an rAd5-Based Prophylactic Prime-Boost HIV Vaccine Strategy. PLoS One 11:e0152952
Churchyard, Gavin; Mlisana, Koleka; Karuna, Shelly et al. (2016) Sequential Immunization with gp140 Boosts Immune Responses Primed by Modified Vaccinia Ankara or DNA in HIV-Uninfected South African Participants. PLoS One 11:e0161753
Hertz, T; Logan, M G; Rolland, M et al. (2016) A study of vaccine-induced immune pressure on breakthrough infections in the Phambili phase 2b HIV-1 vaccine efficacy trial. Vaccine 34:5792-5801
Mkhize, Nonhlanhla N; Durgiah, Raveshni; Ashley, Vicki et al. (2016) Broadly neutralizing antibody specificities detected in the genital tract of HIV-1 infected women. AIDS 30:1005-14
Lemos, M P; Karuna, S T; Mize, G J et al. (2016) In men at risk of HIV infection, IgM, IgG1, IgG3, and IgA reach the human foreskin epidermis. Mucosal Immunol 9:798-808

Showing the most recent 10 out of 107 publications