This proposal describes the Harvard Medical School (HMS) Vaccine Clinical Trials Unit (CTU), which is comprised of an administrative component at HMS, two Clinical Research Sites (CRSs) at Brigham and Women's Hospital (BWH) and Fenway Community Health Center (FCH), and is supported by a processing laboratory at Beth Israel Deaconess Medical Center (BIDMC). The CTU will be affiliated with the Vaccine Network and represents a continuation of the highly successful Harvard HVTU which has been the lead enrolling unit in the HIV Vaccine Trials Network (HVTN) for the past three years, which maintains consistently high scores in the Network Evaluation System, and whose members play important leadership roles in the HVTN. The CTU will be led by highly experienced clinical investigators in the field of HIV vaccines who have collaborated effectively for the past five years. Dr. Raphael Dolin will serve as Principal Investigator (PI) for the CTU, and Drs. Lindsey Baden and Kenneth Mayer will serve as CRS site-PIs for BWH and FCH respectively. Dr. Dolin will also oversee the supporting laboratory at BIDMC. The collaboration among the components of the proposed CTU takes advantage of the special strengths of each site and results in a synergy of activities toward the goals of the Vaccine Trials Network. The BWH CRS is a university-based site with strong ties to local college populations, medical center employees, and has broad-based research programs. FCH is a community-based health center with strong ties to gay, lesbian, bisexual, and transgender communities and with well developed relationships with communities of underrepresented minorities. The laboratory at BIDMC has well-established sample processing procedures and also has other highly developed HIV laboratory capabilities. The CTU and its component CRSs are fully established to carry out the broad spectrum of activities required by the Network. These activities are fully integrated under the guidance of the CTU, and include community outreach, recruitment, and education programs, a single community advisory board (CAB), a single common pharmacy, centralized sample processing, and coordinated quality management. Common standard operating procedures (SOPs) have been developed through the Harvard HVTU for both CRS sites. While this Unit has participated in a broad spectrum of HIV vaccine trials, the CTU has particular interest in studies of adenovirus vectors, novel adjuvants, and mucosal immunity. We project that the Harvard HVTU will follow 176 subjects in year 6 of the current award, and at least 146 subjects in year 1 of the proposed award. Thus, 80 to 100 subjects will be followed at each CRS annually. We also anticipate that we could expand to enroll 500 subjects for a Phase III trial when one is undertaken.

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 #
5UM1AI069412-07
Application #
8413862
Study Section
Special Emphasis Panel (ZAI1-TP-A (M2))
Program Officer
Tauscher, Gail H
Project Start
2007-01-15
Project End
2013-12-09
Budget Start
2013-01-01
Budget End
2013-12-09
Support Year
7
Fiscal Year
2013
Total Cost
$1,086,687
Indirect Cost
$156,085
Name
Beth Israel Deaconess Medical Center
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code
02215
Hendrix, Craig W; Andrade, Adriana; Bumpus, Namandjé N et al. (2016) Dose Frequency Ranging Pharmacokinetic Study of Tenofovir-Emtricitabine After Directly Observed Dosing in Healthy Volunteers to Establish Adherence Benchmarks (HPTN 066). AIDS Res Hum Retroviruses 32:32-43
Nelson, LaRon E; Wilton, Leo; Moineddin, Rahim et al. (2016) Economic, Legal, and Social Hardships Associated with HIV Risk among Black Men who have Sex with Men in Six US Cities. J Urban Health 93:170-88
Landovitz, Raphael J; Tran, Thuy Tien T; Cohn, Susan E et al. (2016) HIV Transmission Risk Behavior in a Cohort of HIV-Infected Treatment-Naïve Men and Women in the United States. AIDS Behav 20:2983-2995
Jacobson, Jeffrey M; Zheng, Lu; Wilson, Cara C et al. (2016) The Safety and Immunogenicity of an Interleukin-12-Enhanced Multiantigen DNA Vaccine Delivered by Electroporation for the Treatment of HIV-1 Infection. J Acquir Immune Defic Syndr 71:163-71
Baden, Lindsey R; Karita, Etienne; Mutua, Gaudensia et al. (2016) Assessment of the Safety and Immunogenicity of 2 Novel Vaccine Platforms for HIV-1 Prevention: A Randomized Trial. Ann Intern Med 164:313-22
Chan, Ellen S; Landay, Alan L; Brown, Todd T et al. (2016) Differential CD4+ cell count increase and CD4+ :  CD8+ ratio normalization with maraviroc compared with tenofovir. AIDS 30:2091-7
Walsh, Stephen R; Moodie, Zoe; Fiore-Gartland, Andrew J et al. (2016) Vaccination With Heterologous HIV-1 Envelope Sequences and Heterologous Adenovirus Vectors Increases T-Cell Responses to Conserved Regions: HVTN 083. J Infect Dis 213:541-50
Girouard, Michael P; Sax, Paul E; Parker, Robert A et al. (2016) The Cost-effectiveness and Budget Impact of 2-Drug Dolutegravir-Lamivudine Regimens for the Treatment of HIV Infection in the United States. Clin Infect Dis 62:784-91
Li, Jonathan Z; Etemad, Behzad; Ahmed, Hayat et al. (2016) The size of the expressed HIV reservoir predicts timing of viral rebound after treatment interruption. AIDS 30:343-53
Fogel, Jessica M; Hudelson, Sarah E; Ou, San-San et al. (2016) Brief Report: HIV Drug Resistance in Adults Failing Early Antiretroviral Treatment: Results From the HIV Prevention Trials Network 052 Trial. J Acquir Immune Defic Syndr 72:304-9

Showing the most recent 10 out of 85 publications