Plenary 04: Emerging Clinical Trial Data

Thursday, 10 October | 10:30 – 12:50

Tomas Hanke

PL04.01 | 10:30 – 10:55
The First Clinical Evaluation of Conserve-Region Vaccines in Humans

Tomas Hanke
University of Oxford, United Kingdom

 

Biography

Professor Hanke directs the HIV-1 Vaccine Program at the Jenner Institute, University of Oxford. His group in collaboration with other experts in the field takes a multi-pronged strategy to HIV-1 vaccine development, which combines several novel approaches and newly emerging technologies to maximize the potential for inducing protective T cell and broadly neutralizing Ab responses. In essence, new vaccines are progressed in an iterative process from bench construction to first mouse and non-human primate models, and then to humans. Professor Hanke has been the chief investigator and/or collaborates on a number of HIV-1 vaccine trials in UK, Spain and Africa involving healthy and HIV-1-infected adults as well as two vaccine trials in neonates born to healthy and HIV-1-infected mothers.

 

 
Muhammad Bakari

PL04.02 | 10:55 – 11:20
The HIVIS and TaMoVac Studies, a North - South Collaboration

Muhammad Bakari
Muhimbili University of Health and Allied Sciences, United Republic of Tanzania

Biography

Muhammad Bakari is an Associate Professor of Internal Medicine at the Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania. He received his initial medical training in Tanzania, and later a PhD from the Karolinska Institutet (KI), Sweden.

He was Study Director of the HIV Vaccine Immunogenicity Study (HIVIS) - 03 project. He also was overall Project Co-ordinator and MUHAS site PI of the European and Developing Countries Clinical Trials Partnership (EDCTP) - funded Tanzania and Mozambique HIV Vaccine (TaMoVac) - 01 project. He is currently the MUHAS site PI for the EDCTP funded TaMoVac-II project. He is also the project co-odinator for the Swedish International Development Agency (Sida) - funded HIV-TB sub-programme at MUHAS.

He has a wide teaching, research and clinical care experience in a resource constrained setting, and has had a wide experience in research collaboration with various partners.

 

 
Merlin Robb

PL04.03 | 11:20 – 11:45
Looking Back to Move Forward: Understanding ALVAC/AIDSVAX Immune Responses

Merlin Robb
U.S. Military HIV Research Program (MHRP)

Biography

Dr. Merlin Robb is the Deputy Director for Clinical Research for the U.S. Military HIV Research Program (MHRP). He is a board certified pediatric infectious disease specialist with research experience in molecular biology, neutralizing antibody assay development, perinatal and pediatric HIV research, HIV correlates of protection research, acute infection studies, HIV immuno-therapeutic trials, the design and conduct of Phase I, II and III clinical trials and the strategic planning and organization of vaccine development programs for East Africa. Dr. Robb was instrumental in developing MHRP’s global research infrastructure in Uganda, Kenya, Tanzania, Nigeria, Mozambique and Thailand.

Dr. Robb has contributed to HIV vaccine prevention and therapy research since 1992 to include the first study to show protection from infection with an HIV vaccine, the recently completed phase III HIV vaccine trial in Thailand, also known as RV144.

Dr. Robb joined MHRP in 1990 while on active duty in the US Army and is currently employed by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF), and serves as the HJF director for MHRP. MHRP is a collaboration between HJF and the Walter Reed Army Institute of Research (WRAIR) Division of Retrovirology.

 
Georgia Tomaras

PL04.04 | 11:45 – 12:10
Vaccine Induced Antibody Responses in HVTN 505, A Phase IIb HIV-1 Efficacy Trial

Georgia Tomaras
Duke University, USA

Biography

Dr. Georgia Tomaras is an Associate Professor of Surgery, Immunology, and Molecular Genetics and Microbiology at Duke University Medical Center. Dr. Tomaras is the P.I. of the Laboratory of Immune Responses and Virology, Director of the DHVI Training Program, and Associate Director of Research for the Duke Human Vaccine Institute. She is Director of the Duke Laboratory for the HIV Vaccine Trials Network (HVTN, NIH) and the CAVD-VIMC Binding Antibody laboratory (Bill and Melinda Gates Foundation). Dr. Tomaras has authored over 95 publications that focus on understanding the ontogeny of HIV-1 immune responses and identifying humoral immune correlates for vaccine trials. Dr. Tomaras' research involves the study of mucosal and systemic antibody responses, ontogeny of neutralizing antibodies, and antiviral HIV-1 T cell responses. Dr. Tomaras is on the editorial board of several international journals and is an NIH NIAID Advisory Council Member, and ARAC and AVRS Subcommittee Member.

Dr. Tomaras received her B.S. in Biology from the University of Michigan, Ann Arbor, MI, her Ph.D. from SUNY Upstate Medical University, Syracuse, NY, and completed her postdoctoral fellowship in HIV/AIDS at Duke University, Durham, NC.

 

 
Glenda Gray

PL04.05 | 12:10 – 12:30
An Update on the Phambili/HVTN 503 Study, a Phase IIB HIV Vaccine Efficacy Study
Investigating MRK Ad5 HIV-1 Subtype B gag/pol/nef Vaccine

Glenda Gray
Perinatal HIV Research Unit, South Africa

Biography

Glenda Gray, MBBCH, FCPaeds (SA), is the executive director of the Perinatal HIV Research Unit and Research Professor based at the University of the Witwatersrand, South Africa as well as the Director of the Office of AIDS Research at the SA-MRC. She is the Co-PI of the HIV Vaccine Trials Network and Director of HVTN International Programs. In 2002, she was awarded the Nelson Mandela Health and Human Rights Award for pioneering work done in the field of Mother-to-Child Transmission of HIV-1. She is a member of the Academy of Science in South Africa, and chairs their standing committee on health. She is a member of the Institute of Medicine, of the National Academies, serves on their Global Health Board.

Gray has also been awarded the IAPAC "Hero of Medicine" award for work done in the field of HIV treatment in children and adults. In 2009, James McIntyre and Gray received the N'Galy-Mann lectureship in recognition of their HIV research contribution in South Africa.  In June 2012 she received a DSc honoris causa from the Simon Fraser University, Vancouver. She has also been admitted into the American Academy of Microbiology in 2012. In 2013 she received  the country's highest honour, the Order of Mapungubwe, granted by the president of SA for achievements in the international area which have served South Africa's interest.

 
 
Peter Gilbert

PL04.06 | 12:35 – 13:00
Meta-Analysis of Ad5-vector HIV Vaccine Trials to Assess the Vaccine Effect on HIV Acquisition

Peter Gilbert
Fred Hutchinson Cancer Research Center, USA

Biography

Peter Gilbert is a member of the Vaccine and Infectious Disease and Public Health Sciences Divisions of the Fred Hutchinson Cancer Research and a Research Professor in the Department of Biostatistics at the University of Washington. As Principal Investigator of the Statistical Data Management Center for the HIV Vaccine Trials Network, his research focuses on the statistical design and analysis of HIV vaccine trials, with emphasis on assessing immune correlates of vaccine-induced protection within efficacy trials, including the sieve analysis of HIV sequences infecting trial volunteers. This research contributes to general areas of statistical methods research including surrogate endpoint assessment, causal inference, survival analysis and efficient randomized trial design, and has application to vaccine efficacy trials for a variety of pathogens. Collaborating with many investigators including from the Thai Ministry of Health, the US Military HIV Research Program, CHAVI, and the HVTN, Dr. Gilbert provided biostatistical leadership for the RV144 'Thai trial' immune correlates and sieve studies that developed a process for immune correlates discovery.