Opening Plenary: State of the Art: Biomedical Prevention in 2014
Tuesday, 28 October | 08:15 - 10:30
PL01.01: Prospects for an Antibody-based HIV Vaccine
Intensive efforts to develop a preventive HIV vaccine have been significantly bolstered by recent discoveries of broad and potent neutralizing antibodies in some HIV infected humans. Many of these antibodies have unusual genetic features that present a significant challenge for conventional vaccine approaches. Nevertheless, longitudinal studies are revealing how such lineages evolve and enabling the identification of germline B cells that an HIV vaccine would need to stimulate. Parallel viral genetic analysis further demonstrates how viral evolution shapes these responses. Collectively such studies in HIV- infected humans who develop broadly cross-neutralizing antibodies are providing important clues for HIV vaccine design.
Lynn Morris, DPhil is Chief Specialist Scientist and Head of the AIDS Unit at the National Institute for Communicable Diseases (NICD) in Johannesburg, South Africa. She also holds a joint appointment at the University of the Witwatersrand.
For the past 13 years, Dr. Morris has been involved in researching the virological and immunological aspects of local HIV-1 subtype C strains. This includes the genetic and biologic characterization, co-receptor usage and neutralization sensitivity, as well as measuring neutralizing antibodies in infected persons. This latter area of interest developed as a result of her sabbatical at the Aaron Diamond AIDS Research Centre where she examined antibody and B-cell function in persons receiving highly active antiretroviral therapy. HIV vaccine development is a major focus of Dr. Morris' research. She is part of the HIV Vaccine Trials Network and will be responsible for performing neutralizing antibody assays on HIV vaccine clinical trials conducted in South Africa. Dr. Morris is a member of the CAPRISA Executive Committee and the SAAVI management team.
Centre for HIV & STI's: HIV Virology, National Institute for Communicable Diseases of the NHLS, Johannesburg, South Africa, University of the Witwatersrand, Johannesburg, South Africa
Jared M. Baeten M.D., Ph.D. is a professor in the Departments of Global Health, Medicine, and Epidemiology at the University of Washington. His research focuses on the prevention of HIV-1 and other sexually transmitted diseases, including clinical trials of novel prevention interventions, epidemiologic studies of risk factors for HIV-1 transmission and biobehavioral and implementation science research aimed at optimizing prevention delivery. He co-chaired the Partners PrEP Study, a phase III, randomized clinical trial among 4747 HIV-1 uninfected heterosexual men and women in Kenya and Uganda that demonstrated pre-exposure prophylaxis (PrEP) provided protection against HIV-1 acquisition. Current projects include a multinational phase III trial of dapivirine vaginal ring for HIV-1 prevention in women (MTN-020/ASPIRE, through the NIH Microbicides Trials Network, for which he serves as protocol chair); implementation science work to deliver antiretroviral treatment and PrEP for HIV-1 prevention in African HIV-1 serodiscordant couples (the Partners Demonstration Project); epidemiologic studies exploring use of hormonal contraception as a risk factor for HIV-1, and; collaborative studies of immunologic and virologic factors that influence HIV-1 transmission.
University of Washington, Seattle, WA, United States
PL01.03: Comprehensive HIV Prevention: Synergy Between Vaccine and Non-Vaccine Modalities
Anthony S. Fauci, M.D., is director of the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health. Since his appointment as NIAID director in 1984, Dr. Fauci has overseen an extensive research portfolio devoted to preventing, diagnosing, and treating infectious and immune-mediated diseases. Dr. Fauci also is chief of the NIAID Laboratory of Immunoregulation, where he has made numerous important discoveries related to HIV/AIDS and is one of the most-cited scientists in the field. Dr. Fauci serves as one of the key advisors to the White House and Department of Health and Human Services on global AIDS issues, and on initiatives to bolster medical and public health preparedness against emerging infectious disease threats such as pandemic influenza. He was one of the principal architects of the President's Emergency Plan for AIDS Relief (PEPFAR).
Dr. Fauci is a member of the US National Academy of Sciences and is the recipient of numerous awards for his scientific and global health accomplishments, including the National Medal of Science, the Mary Woodard Lasker Award for Public Service, and the Presidential Medal of Freedom. He has been awarded 38 honorary doctoral degrees and is the author, coauthor, or editor of more than 1,200 scientific publications, including several major textbooks.
National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, United States
Plenary 02: Targeting Biomedical Preventions to Different At-Risk Populations
Wednesday 29 October | 08:30 - 10:00
PL02.01: Tailoring Biomedical Preventive Interventions for Key Populations: Towards Safety, Efficacy, Effectiveness
Chris-BeyrerChris Beyrer M.D, M.P.H., is professor of epidemiology, International Health and Health, Behavior and Society at the Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland. He serves as director of Johns Hopkins HIV Training Program in Epidemiology and Prevention Science, and founded and directs the university's Center for Public Health and Human Rights. He is co-principal investigator of the Johns Hopkins Center for AIDS Research (CFAR) and also serves as associate director of the Johns Hopkins Center for Global Health. He has extensive experience in conducting international collaborative research and training programs in HIV/AIDS and other infectious disease epidemiology, in infectious disease prevention research, HIV vaccine preparedness, in health and migration and in health and human rights.
Dr. Beyrer served as field director of the Thai PAVE and HIVNET studies from 1992-1996, and has conducted extensive research in the epidemiology of HIV among key populations in Thailand, Burma, China, India, South Africa, Malawi, Tanzania, Russia and Kazakhstan. He is the author of over 200 scientific papers, authored the 1998 book War in the Blood: Sex Politics and AIDS in Southeast Asia and co-edited the 2008 book Public Health and Human Rights: Evidence-based Approaches. He became president of the International AIDS Society in July, 2014.
Epidemiology, Johns Hopkins Bloomberb School of Public Health, Baltimore, MD, United States
PL02.02: Working with Special Populations within HIV Prevention Intervention Programs and Trials
It is well accepted that effective HIV prevention must target the high risk populations in particular local epidemics, and that working collaboratively with these affected populations to design and deliver prevention interventions is an ethical requirement that can maximise uptake and acceptability.
In 2014, we have a greater than ever range of interventions to prevent HIV, but access, sustainability and adherence remain major issues, and there is no established optimal formula for implementing combination HIV prevention approaches in the specific population groups who need them most. In addition, some of the social and political barriers to effective implementation within key populations have become more entrenched. This poses particular problems both for ongoing research into new interventions and for programmatic implementation of proven interventions.
This plenary will look at the evidence about the use of HIV prevention in particular populations, and consider how HIV prevention research and implementation can work within a broader human rights framework that takes into account social and political barriers that affect vulnerability, sustainability and adherence to prevention interventions.
Bridget-HaireBridget Haire is a lecturer in public health and medical ethics at the University of New South Wales, Australia, and is vice president of the Australian Federation of AIDS Organisations. She also lectures in bioethics and medical humanities at the Centre for Values, Ethics and the Law in Medicine at the University of Sydney. Prior to academia, Dr. Haire worked in HIV and sexual and reproductive health for 20 years as a journalist, editor, policy analyst and advocate. She currently acts as a consultant for the Australia-China Human Rights Technical Co-operation Program on sexual and reproductive health rights and serves on the Data Safety Monitoring Board for the South African HIV prevention study CAPRISA 008. Her doctorate was on standards of care in HIV prevention research.
School of Public Health and Community Medicine, University of New South Wales, Sydney, Australia, Centre for Values, Ethics and the Law in Medicine, University of Sydney, Sydney, Australia
PL02.03: Tailoring Interventions to Different Populations
UNAIDS estimates there were 6,300 new infections a day in 2012, with 95% of these in low- and middle-income countries. Advances in biomedical HIV prevention are giving us hope that the HIV epidemic can be brought under control.
Since Biomedical, Behavioural and Structural interventions intersect, it is important to understand and engage the different priority populations and communities in order to tailor interventions for maximum benefit. Social behavioural, health systems, community participation, epidemic stage, and policy are some factors that will determine the benefits for priority populations of the advances made in biomedical HIV prevention. For example, in most generalized epidemics effective prevention approaches are required for women who are at a disproportionate risk of HIV acquisition for biological as well as social reasons. Mobilising and meaningfully engaging key populations, such as people who inject drugs (PWID), men who have sex with men (MSM), sex workers (SW), and the fisherfolk (FF) in some countries will take different forms in local contexts for these often hard to reach populations. For example, in our studies in Uganda among SW, interventions are provided through special clinics, staffed by skilled health workers with knowledge and understanding of the sex work milieu, offer friendly services and involvement of peers in mobilisation and follow up. For both SW and FF, localising clinics and services nearer to their places of work is essential to their involvement. For FF this includes providing services that are open hours when they are not working. Examples of other tailored programmes engaging populations such as MSM and adolescents will be discussed.
Investing resources and focusing national HIV prevention campaigns on well-defined strategies for and with populations that are key to the epidemic and key to the response will increase the potential for biomedical interventions to slow the HIV epidemic, reducing new infections.
Pontiano-BioPontiano Kaleebu is the director of the MRC/UVRI Uganda Research Unit on AIDS and head of MRC-UVRI Basic Sciences Programme. He is also deputy director of research at the Uganda Virus Research Institute and head of Immunology Department of UVRI. He is honorary professor, London School of Hygiene and Tropical Medicine, Faculty of Infectious and Tropical Diseases and a honorary professor at the Makerere University School of Biomedical Sciences.
Dr. Kaleebu's major areas of interest include understanding protective immune responses against HIV, vaccine trial design, HIV molecular epidemiology and resistance to anti-retroviral drugs. He has served on national and International committees including the WHO HIV vaccine advisory committee and the Global HIV Vaccine Enterprise Scientific committee. He chairs the National HIV Drug Resistance Working Group, and was the chair of the African AIDS Vaccine Programme Steering committee under WHO/UNAID for many years. He was admitted to the Fellowship of the Faculty of Medicine of Imperial College in 2011.
MRC/UVRI Uganda Research Unit on AIDS, Uganda
Plenary 03: Importance of Mucosa in Prevention Research
Thursday 30 October | 08:30 - 10:00
PL03.01: Utilizing NHP Models to Understand Mucosal HIV Transmission and Dissemination
Over 80% of sexual HIV-1 transmissions originate from a single viral variant, but the underlying basis for this transmission bottleneck remains to be elucidated. Nonhuman primate models of mucosal virus transmission allow opportunities to gain insight into the basis of this mucosal bottleneck. This talk will focus on studies that utilize NHP models to understand i) the host innate antiviral responses during the earliest time points after mucosal SIV challenge and ii) the lymphatic drainage pathways of viral dissemination in order to better elucidate the earliest events of virus mucosal transmission and potential intervention strategies.
Jake-EstesJacob D. Estes, Ph.D. heads both the Retroviral Immunopathology Section and Tissue Analysis Core (TAC) in the AIDS and Cancer Virus Program (ACVP) at the National Cancer Institute of the NIH. His research focuses have included the contributions of follicular dendritic cells and the germinal center microenvironment to HIV pathogenesis, and the in vivo immunopathogology of lentiviral infections in lymphatic tissues in both human patient cohorts and non-human primate models.
Dr. Estes joined the AIDS and Cancer Virus Program in 2007 and was named the head of the TAC in 2009. The TAC provides state-of-the art tissue analysis capabilities (i.e. immunofluorescence, immunohistochemistry, in situ hybridization, quantitative image analysis, laser capture microdissection) for ACVP directed studies and in support of intramural and extramural investigators working on collaborative studies relevant to key questions in HIV/AIDS research, with an emphasis on analysis of specimens from non-human primate models.
AIDS & Cancer Virus Program, Leidos Biomedical Research, Inc., Frederick National Laboratory for Cancer Research, Frederick, MD, United States
PL03.02: Genital Inflammation and HIV Risk in Prevention Research
Joann-PassmoreJo-Ann Passmore Ph.D. is a medical scientist with the National Health Laboratory Services, an associate professor in the Division of Medical Virology, Institute for Infectious Diseases and Molecular Medicine, University of Cape Town and a research associate at the Centre for the AIDS Programme of Research in South Africa (CAPRISA). She heads the Genital Mucosa and STI Research Group in the Institute for Infectious Diseases and Molecular Medicine, University of Cape Town and the CAPRISA Mucosal Research Laboratory at the University of Kwa-Zulu Natal. Dr. Passmore's research focuses on studying genital tract adaptive and innate immune responses associated with protection from or susceptibility to sexually transmitted viral diseases including HPV and HIV.
Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa, National Health Laboratory Service, Cape Town, South Africa, CAPRISA, Durban, South Africa
PL03.03: Mucosal Immune Assays in HIV Vaccine Clinical Trials
Background: Mucosal immune responses and mucosal sampling from genitourinary (GU) and gastrointestinal (GI) tracts are at an increased focus for HIV vaccine research and development as well as other HIV prevention and treatment strategies that are targeted at mucosal surfaces. This is in realization that mucosal surface forms the major route of HIV acquisition and transmission across the world.
Collection of mucosal samples during the conduct of clinical trials is associated with significant operational challenges, expenses, as well as some risk and discomfort to study participants. It is therefore critical that appropriate measures are taken into account including, (clinical, behavioral, and demographic characteristics) from study participants so that factors that may influence mucosal immunology and thus the interpretation of assay data are efficiently captured in parallel with mucosal specimens during the conduct of clinical trials. KAVI-Institute of Clinical Research at the University of Nairobi, and others have studied the acceptability and tolerability of repeated mucosal sampling in clinical trial participants as well as other participants at low risk of HIV infection.
To this end the samples obtained were also used to establish and standardize the immune assays for adaptation in evaluation of mucosal immune responses in clinical trials.
Discussion: Repeated mucosal sampling is achievable both in HIV-infected and in healthy adult HIV uninfected clinical trials participants. The sampling methods that have been studied include saliva, oral fluids, semen, cervical, vaginal, rectal, and gut. Participants consented to most specimen collection methods with the exception of rectal sampling.
Samples obtained are of good quality for process, analysis and can be standardized for both T/B cell as well antibody assays for adaptation for use in evaluating mucosal immune responses in HIV vaccine clinical trials in addition to peripheral samples.
Oma-BioOmu Anzala, MBChB. Ph.D. is professor of Virology and Immunology of the Department of Medical Microbiology, College of Health Sciences at the University of Nairobi. Previously, he served as the department chair for 5 years and as a member of Developing Countries Clinical Committee for 3 years. Dr. Anzala is also director of The KAVI Institute of Clinical Research (KAVI-ICR), a global health research and training center at the University's College of Health Sciences. KAVI focuses on communicable diseases such as HIV/AIDS, tuberculosis, zoonoses, and childhood respiratory and gastrointestinal diseases; non-communicable diseases such as breast, colon and prostate cancers; as well as diseases of the cardiovascular, respiratory, and endocrine systems. The Institute has conducted basic HIV research, epidemiological research and multiple HIV vaccine trials. KAVI's Knowledge Translation track brings together research, policy and implementation together by building relationships and opportunities for collaboration between researchers and those who benefit from and use the research results.
Dr. Anzala is currently a principal investigator in 2 Phase 1 HIV Clinical Trials as well as the PI of a number of basic HIV research projects. He is a reviewer of the East African Medical Journal and a number of other peer reviewed journals.
College of Health Sciences, KAVI - Institute of Clinical Research (KAVI-ICR), University of Nairobi, Nairobi, Kenya
Closing Plenary: Mind the Gap: Bridging from Trial Success to Access
Friday 31 October | 10:30 - 12:30
PL04.01: Translating "Controlled" Trial Results to the Cities & Villages of Africa: Past, Present, & Future
Douglas-BioDouglas Shaffer, RPh, MD, MHS, is Chief Medical Officer at the Office of the Global AIDS Coordinator. Having spent the last 13 years in Kenya and Rwanda, Dr. Shaffer began work in Kenya in 2001 as a visiting Lecturer at Moi University Teaching and Referral Hospital focusing upon early HIV/AIDS clinical care and research infrastructure/equity. He helped lead the U.S. Government collaboration with the Government of Kenya during the roll out of HIV services under the President's Emergency Plan for AIDS Relief (PEPFAR) in 2004. Since, Dr. Shaffer's career focused on optimizing HIV prevention, care, and treatment services with parallel development of integrated research capacity and leadership. Dr. Shaffer was Principal Investigator of the U.S. Military HIV Research Program AIDS Clinical Trials Group (ACTG) Clinical Trials Unit. He has joined and mentored researchers in Africa on over 40 studies covering HIV epidemiology, health economics, and Phase I-III vaccine & therapeutic clinical trials (including tuberculosis and malaria co-infections). Dr. Shaffer held medical licensure in Kenya and Rwanda where he practiced and taught medicine. Prior to moving to Kenya, Dr. Shaffer was a Senior Medical Officer at the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration.
Office of the U.S. Global AIDS Coordinator, U.S. Department of State, Washington, DC, United States
PL04.02: Scaling-up HIV Prevention Science from the Laboratory to the Village
HIV prevention science requires a critical mass scale-up to have a population impact. The talk will share experiences of scale-up with medical male circumcision and PMTCT and seek to learn lessons that can be utilized for emerging HIV prevention science.
Alex-BioAlex Coutinho, MD, MSc MPH DTM&H, FRCP worked with the first cases of AIDS in Uganda at Nsambya hospital in 1983-85. From 1986-89 was a lecturer at Makerere Medical school. He left to work in Swaziland in 1989 where he started one of the first care programs for HIV+ people in Swaziland. From 2001 -2007, Dr. Coutinho served as executive director of The AIDS Support organization – TASO - in Uganda.
He is currently director of the Infectious Diseases Institute in Kampala, Uganda, which provides care for 100,000 HIV-positive individuals, including 30,000 on ART. IDI also has several ongoing research projects focusing on HIV and related infectious diseases.
Dr Coutinho served as the Vice Chair of the Global Fund Technical Review Panel from 2002- 2004 and as chair of the Board of the International Partnership for Microbicides IPM. He is currently the chair of the IAVI Board and of the Board of the Infectious Diseases Institute at Makerere University. In 2013, he was awarded the Hideyo Noguchi Africa prize for Medical services by the Japanese government.
Director, Infectious Diseases Institute, Kampala, Uganda
Glenda-GrayProfessor Glenda Gray, MBBCH, FCPaeds (SA), is the President and CEO of the South African Medical Research Council and Professor in the Department of Paediatrics, at the Perinatal HIV Research Unit, University of the Witwatersrand. She has done research in the Prevention of Mother-to-Child Transmission (PMTCT), pediatric HIV, and HIV prevention including HIV vaccines and microbicides. She is the Co-PI of the HIV Vaccine Trials Network (HVTN) and Director of HVTN International Programs. In 2002, together with James McIntyre she was awarded the Nelson Mandela Health and Human Rights Award for pioneering work done in the field of MTCT 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. In 2013 she received the country's highest honor, the Order of Mapungubwe, granted by the president of SA for achievements in the international area which have served South Africa's interest. She also received the 2013 European & Developing Countries Clinical Trials Partnership (EDCTP) Award for an Outstanding African Scientist.
Perinatal HIV Research Unit and Medical Research Council, South Africa