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
Wills, Saintedym; Hwang, Kwan-Ki; Liu, Pinghuang et al. (2018) HIV-1-Specific IgA Monoclonal Antibodies from an HIV-1 Vaccinee Mediate Galactosylceramide Blocking and Phagocytosis. J Virol 92:
Fong, Youyi; Shen, Xiaoying; Ashley, Vicki C et al. (2018) Modification of the Association Between T-Cell Immune Responses and Human Immunodeficiency Virus Type 1 Infection Risk by Vaccine-Induced Antibody Responses in the HVTN 505 Trial. J Infect Dis 217:1280-1288
Fong, Youyi; Huang, Ying; Lemos, Maria P et al. (2018) Rank-based two-sample tests for paired data with missing values. Biostatistics 19:281-294
Eren, Kemal; Murrell, Ben (2018) RIFRAF: a frame-resolving consensus algorithm. Bioinformatics 34:3817-3824
Thiam-Diouf, Arame; Metch, Barbara; Sharpe, Cameron et al. (2018) Substance use patterns of HVTN phase I clinical trial participants: Enrollment, risk reduction counseling and retention. Vaccine 36:1235-1242
Layton, Erik D; Yu, Krystle K Q; Smith, Malisa T et al. (2018) Validation of a CD1b tetramer assay for studies of human mycobacterial infection or vaccination. J Immunol Methods 458:44-52
McGuire, Erin P; Fong, Youyi; Toote, Christopher et al. (2018) HIV-Exposed Infants Vaccinated with an MF59/Recombinant gp120 Vaccine Have Higher-Magnitude Anti-V1V2 IgG Responses than Adults Immunized with the Same Vaccine. J Virol 92:
Barouch, Dan H; Tomaka, Frank L; Wegmann, Frank et al. (2018) Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial (APPROACH) and in rhesus monkeys (NHP 13-19). Lancet 392:232-243
Dietrich, Janan J; Lazarus, Erica; Andrasik, Michele et al. (2018) Mobile Phone Questionnaires for Sexual Risk Data Collection Among Young Women in Soweto, South Africa. AIDS Behav 22:2312-2321
Bekker, Linda-Gail; Moodie, Zoe; Grunenberg, Nicole et al. (2018) Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial. Lancet HIV 5:e366-e378

Showing the most recent 10 out of 146 publications