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Satellite Sessions

Please come early and stay late for HIVR4P’s satellite sessions! These independently organized sessions will take place on Monday, October 17 from 08:30 – 15:30 and Friday, October 21 from 09:00 – 12:00. Conference registration is not required for satellite participants or attendees. Some satellites may have a separate process to confirm attendance. Information about these sessions, including locations, times, and hosting institutions, is below. Please click here to view the conference program including satellite session details.


Systemic and Topical Delivery of Anti-HIV Monoclonal Antibodies to Prevent HIV Transmission

8:30 – 11:00
Sheraton Ballroom III

Host Institution: Boston University and Mapp Biopharmaceuticals
Chairs: Deborah Anderson, Boston University School of Medicine; Kevin Whaley, Mapp Biopharmaceutical
Speakers: Deborah Anderson, Boston University School of Medicine; Kevin Whaley, Mapp Biopharmaceutical; Ruth Ruprecht, Texas Biomedical Research Institute; Francois Villinger, New Iberia Primate Center; Kenneth Mayer, Harvard Medical School ; Galit Alter, Harvard Medical School

This workshop will present an overview of anti-HIV monoclonal antibody (mAb) production platforms, nonhuman primate research on HIV mabs and SIV/SHIV infection, research on mAb function in mucosal tissues, and ongoing clinical trials employing the systemic and topical delivery of mabs to prevent HIV transmission. The workshop will end with a panel discussion on future directions of the field.

Addressing the Leading Edge of the HIV Epidemic in the U.S.: Advancing Prevention Programs for Urban YMSM

8:30 – 11:30
Chicago Ballroom VIII

Host Institution: Third Coast Center for AIDS Research
Session Chairs: Alida Bouris, University of Chicago; Sybil Hosek, Stroger Hospital of Cook County; Brian Mustanski, Northwestern University
Keynote: Kenneth Mayer
Panelists: Brian Mustanski; Aditya Khanna; Alida Bouris; Michael Newcomb; Sybil Hosek

Experts in social, biomedical, and network sciences will present research on the HIV prevention needs of urban young men who have sex with men (YMSM). The session will detail recent trends in the domestic HIV epidemic among men who have sex with men (MSM), provide insight into structures that determine HIV risk, and discuss the path forward as exisiting and future interventions are implemented.
Keynote, Kenneth Mayer, MD will present recent survey and epidemiologic data on the state of the HIV epidemic in YMSM. The keynote will discuss ongoing prevention efforts and identify opportunities for expanding prevention initiatives.

Panel 1. Social and network factors that drive the HIV epidemic. Scientists will examine HIV risk through the lense of interpersonal relationships at mutiple levels (sexual/romantic dyads, families, and social/sexual networks).
Panel 2. Engagement and adherence strategies for biomedical prevention. Experts will present up-to-the-minute results on biomedical prevention acceptability, uptake, adherence, and outcomes for YMSM.

The Next Wave in HIV Prevention: Multipurpose Prevention Technologies (MPTs)

8:30 – 11:30

Host Institution: Initiative for Multipurpose Prevention Technologies (IMPT)
Session Chairs: Bethany Young Holt, IMPT; Elizabeth Bukusi, Kenya Medical Research Institute (KEMRI); Helen Rees, Wits Reproductive Health and HIV Institute
Speakers: Martha Brady, Population Council; Mike Chirenje, UZ-UCSF Collaborative Research Programme; Amy Lin, USAID; Kavita Nanda, FHI 360; Joseph Romano, IMPT/NWJ Group; Andrea Thurman, CONRAD; Everlyne Ombati, IMPT/KEMRI

Multipurpose prevention technologies (MPTs) are an important class of prevention options for women offering combinations of HIV protection, other STI protection, and contraception. MPTs have high potential for public health impact, and achieving this potential can be attained only through optimized funding and objective and informed consideration of market drivers and technical aspects of MPT development and delivery. Building from the key recommendations from the IMPT’s technical meeting on MPT clinical trial evaluation and design (CTED) Clinical Evaluation Workshop for MPTs in September, the objective of this satellite is to further the development of a consensus strategy unifying funders, developers, and market entities in the product neutral assessment of relevant MPT market drivers and technical options, and eliminate impediments to appropriate MPT development define the technical, clinical and market data required to justify progressing an appropriately optimal MPT product through regulatory licensure and into a successful commercial launch. This session will 1) examine the value and impact potential of MPTs; 2) assess key MPT market drivers and data needs; and 3) identify relevant technical considerations that are responsive to MPT market drivers. Panels of product development, advocacy, social-behavioral, and market evaluation experts will report back on CTED clinical trial meeting recommendations and participate in focused discussions of these critical issues. Session attendees will be directly engaged in structured discussions to inform multi-faceted strategies to achieve successful development and uptake of MPTs.

HIV Vaccine Design and Development Partnerships in Africa: Showcasing African-led Basic HIV Prevention Science Research

8:30 AM – 12:30
Chicago Ballroom IX

Hosting Institutions: Medical Research Council (MRC)/Uganda Virus Research Institute (UVRI); Global HIV Vaccine Enterprise (GHVE); International AIDS Vaccine Initiative (IAVI)
Chairs: Pontiano Kaleebu, Medical Research Council/Uganda Virus Research Institute (MRC/UVRI) and UVRI; Tumani Corrah, Africa Research Development, Medical Research Council (MRC), The Gambia; Margaret McCluskey, HIV Vaccines, US Agency for International Development (USAID); William Snow, Secretariat of the Global HIV Vaccine Enterprise (GHVE)

Despite impressive capacity strengthening for HIV research in Africa, there are still gaps. Many of the efforts were directed toward epidemiological and clinical studies, but basic science research capacity is still low. New partnership models are beginning to increase the engagement of Africans in Africa in basic HIV prevention research. This brings novel opportunities for North-South and South-South collaborations for discovery and innovation and promotes multidisciplinary approaches. The coming wave of change facilitates more initiatives addressing these gaps while harnessing the role African scientists and institutions play in basic research. We will bring together African scientists, policy makers, advocates, and institutions involved in HIV prevention research to share success stories, identify gaps and challenges, and propose opportunities for enhanced collaborations with a focus on discovery and innovation, as well as young scientists. The session will feature design and development partnership models, each with a brief overview from a leadership representative and short presentations by two junior investigators. In advance and during the session, presenters and participants (and those who can’t attend) will be invited to share their ideas of the next priorities for African research. These will be discussed in a final panel discussion on the way forward.

Advocates Pre-conference Workshop: Strengthening Advocacy for Research to Rollout

8:30 AM – 15:00

Host Institution: AVAC

The current landscape in HIV prevention offers new opportunities and challenges to advocates across the world involved and/or interested in biomedical HIV prevention research and development as well as the implementation of positive results into policies and programs. Advocates are at the forefront of advocating for the rollout of PrEP as well as helping to develop guidelines and implementation plans to roll it out. They are key collaborators in efforts to monitor rollout of early treatment and VMMC, as well contribute to the important dialogues on how research for new interventions for women’s prevention meets women’s needs. Advocates have championed the voices of key groups whose access to new interventions is imperative if they are to be successful and, as a result, have helped bring them to the table. At the same time, they are engaged in discussions around trials of vaccines, long-acting injectables, antibody mediated prevention and multipurpose prevention technologies.

International and national advocacy partners will hold a day-long pre-conference workshop to equip advocates, new investigators, community liaison officers at trials and other interested stakeholders to more fully participate in biomedical HIV prevention research and the HIV R4P conference. The workshop will provide an overview of the field to contextualize the themes and issues that will be presented at HIV R4P; will connect research and advocacy priorities and explore common goals; and build the capacity of advocates and trial staff to better engage with emerging issues in the field.

The pre-conference workshop will feature seasoned advocates and researchers from the HIV prevention research field who will provide new and experienced advocates, community representatives and trial staff with latest updates and previews on topics to be presented at the conference.

Please click here to view the full session agenda, and click the link below to register for the Advocates pre-conference workshop.

From Basic to Population Sciences: How to Understand and Prevent HIV Transmission: Vaccines and Sexual Transmission

9:00 – 10:30 AM
Chicago Ballroom X

Host Institution: Sidaction
Session Chairs: Jean-Daniel Lelièvre, INSERM/Vaccine Research Institute (VRI); Bonnie Mathieson, Office of AIDS Research, NIH
Speakers: Roger Le Grand, CEA iMETI/Division of Immuno-Virology, CEA; Christiane Moog, Institut de Virologie, Strasbourg; Bertran Auvert, Institut de Biologie et Chimie des Proteines, CNRS, Lyon; Nicolas Nagot, INSERM, Montpellier; Philippe Van De Perre, INSERM, Montpellier

Ending HIV infection requires a better understanding of HIV transmission at the cellular, clinical, and social levels with a comprehensive and innovative approach. Here, outcomes and ongoing research results, spanning from understanding the physiology of the target cell and the initial processes of infection in mucosal tissues in order to develop blocking antibodies and vaccine antigens to the use of biodegradable nanoparticles in HIV vaccine development and the effect of male circumcision in South Africa on HIV infection of women at population scale, will be presented. The current state of the art in biomedical prevention tools such as PrEP, vaccines, and antibodies as well as evidence-based public policies will be discussed.
These multidisciplinary research projects in HIV transmission were funded by the Pierre Bergé endowment fund in collaboration with Sidaction.

Engagement from All Angles: Advocates, Sponsors, and Implementers Discuss GPP in Action

9:00 – 11:00
Sheraton II

Host Institution: AVAC
Session Chairs: Stacey Hannah, AVAC; Deborah Baron, Wits Reproductive Health and HIV Institute
Speakers: Sinazo Pato, Wits Reproductive Health and HIV Institute; Helen Rees, Wits Reproductive Health and HIV Institute; Mitchell Warren, AVAC

The Good Participatory Practice Guidelines (GPP) provide implementers with a framework for broad stakeholder engagement throughout research processes. GPP is increasingly becoming the gold standard of engagement practices, especially since the release of the second edition of the guidelines in 2011. As GPP implementation continues, predominantly at trial site level, some debate has emerged over who is responsible for supporting and implementing GPP, whose role it is to involve various stakeholder groups, and when to begin and end trial and/or research engagement. This satellite session will provide an update on global GPP implementation and an interactive discussion around roles and responsibilities of various research entities and advocacy groups, such as AVAC. Case studies will be presented to highlight organizational approaches, successes, and challenges around implementing GPP, including in research studies involving vulnerable populations. A sponsor perspective will articulate how GPP is being implemented beyond individual trial sites and will explore the benefit of an institutional approach to GPP. Finally, session leaders and participants will reflect on the value of monitoring the impact of GPP and how GPP indicators can inform effective stakeholder engagement processes at all levels.

Replicating HIV Prevention Impact Evaluations

9:00 – 11:00

Host Institution: International Initiative for Impact Evaluation
Session Chair: Ben Wood, International Initiative for Impact Evaluation
Speakers: Baojiang Chen, University of Texas Health Science Center; Jiangtao Luo, University of Nebraska Medical Center; Fang Yu, University of Nebraska Medical Center; Lynette Smith, University of Nebraska Medical Center; Eric Djimeu, International

Three decades of work on HIV prevention have yielded a series of effective biomedical, behavioral, social, and structural interventions among specific population groups in small-scale settings and/or in controlled trials. Although most interventions show clear potential for a major impact in reducing HIV and the associated human and economic costs, the importance of the effort to prevent HIV and the magnitude of effort required to scale up any evidence-based intervention require the study results to be carefully reviewed, understood, and confirmed before scaling up interventions. Replications are the most established method of research validation in science. Replications funded by 3ie are internal replications—those that use data from the original study, and possibly existing secondary datasets from the same location, in order to check the validity and robustness of the findings and recommendations in order to inform scaling up interventions. Panelists will present five replications of impact evaluations involving HIV prevention from a Thematic Replication Window that will be published in the International Initiative for Impact Evaluations (3ie) Replication Paper Series. In addition, Ben Wood will present the benefits of replication for impact evaluations around HIV prevention interventions as well as previous replications from 3ie.

Engaging High-risk Fishing Communities in HIV Prevention Research

12:00 – 15:00
Chicago Ballroom X

Host Institution: International AIDS Vaccine Initiative (IAVI)
Session Chairs: Chairs: Anatoli Kamali, International AIDS Vaccine Initiative (IAVI); Saidi Kapiga, Mwanza Interventional Trials Unit, Uganda
Speakers: Elizabeth Bukusi, Kenya Medical Research Institute (KEMRI); Noah Kiwanuka, UVRI-IAVI

Studies in Lake Victoria fishing communities have documented high HIV incidence and limited access to healthcare and HIV services. In fishing communities in Uganda, the overall HIV incidence is about 5-fold greater than the surrounding agrarian population. Incidence is equally high in Kenya and under investigation in Tanzania. The fishing communities are home to over a million people, and heterogeneous in structure. HIV risks vary with occupation, mobility, age, and alcohol use. The Lake Victoria Health Research Consortium (LVHRC), composed of research organizations in Uganda, Kenya, and Tanzania, with IAVI, is conducting research activities among the fishing communities and has demonstrated that the populations can be meaningfully engaged in health research and that this population could be important for large-scale HIV prevention trials. This session will provide brief descriptions and characteristics of the cohorts and key research questions addressed with an emphasis on HIV epidemiology and risk factors, HIV prevention/care interventions. The session will in addition review the access to care, engagement in research, and care. Discussion will focus on additional research questions, ethical concerns, and the potential for Lake Victoria fishing communities to participate in future large-scale HIV prevention studies and treatment scale-up.

Non-human Primate Models for HIV and Other STIs Prevention

12:00 – 15:00
Sheraton Ballroom II

Host Institution: Population Council
Session Chair: Elena Martinelli, Population Council
Speakers: Walid Heneine, Centers for Disease Control and Prevention; Nina Derby, Population Council; Dorothy Patton, University of Washington; Natalia Teleshova, Population Council; Jeffrey Lifson, National Cancer Institute at Frederick; Dan Barouch, Center for Virology and Vaccine Research, BIDMC, Harvard Medical School

Non-human primates (NHPs) have been indispensable for modeling HIV susceptibility, infection, and pathogenesis, as well as for the development of prophylactic and therapeutic interventions. Macaque models are used to evaluate safety and determine pharmacokinetics (PK)/pharmacodynamics (PD) relationships of prevention products. Several SIV and chimeric SIV/HIV (SHIV) models in macaques are utilized for testing efficacy of HIV prevention strategies. These models encompass both stringent high viral dose challenge, often with progesterone pre-treatment to thin the vaginal epithelium, and the more physiologically relevant repeated low-dose challenge. Importantly, studies carefully mimicking the designs of vaccine (Step) and PreP (iPrEx) clinical trials suggest that NHP models can recapitulate the results of studies in humans. Recently, new in vivo (HSV-2, T. vaginalis and C. trachomatis) and ex vivo (HSV-2) STI models (single or coinfection with SHIV) were established, providing an opportunity to test prevention strategies in high-risk HIV transmission settings. Session objectives include: 1. Show how macaques are a valuable tool to test preclinical safety and efficacy of microbicides, PrEP, and vaccines targeting HIV and/or other STIs, 2. Discuss selection of models for prevention studies in macaques, 3. Discuss future strategies for prevention studies in macaques.

Vaccine-elicited Immunity in the Pediatric Immune System

12:00 – 15:00
Sheraton Ballroom III

Host Institution: Division of AIDS, NIAID, NIH
Organizer: Sallie R. Permar, Duke University Medical Center; Anjali Singh, Division of AIDS, NIAID, NIH
Panelist: Rebecca D. Adkins, University of Miami; Kristina De Paris, University of North Carolina School of Medicine; Hayley A. Gans, Stanford University; Ann J. Hessell, Oregon Health And Science University; Tobias R. Kollmann, University of British Columbia; Ofer Levy, Boston Children’s Hospital; Joseph Mccune, University of California San Francisco; Elizabeth J. Mcfarland, Children’s Hospital Colorado; Julie Overbaugh, Fred Hutchinson Cancer Research Center; Octavio Ramilo, The Ohio State University; Stuart Z. Shapiro, Division of AIDS, NIAID, NIH; Georgia D. Tomaras, Duke University School of Medicine

Despite the success of many vaccines in the young age groups, our understanding of vaccine-elicited immune responses in infants and how they differ from those of adults remains limited. Important factors that distinguish the infant immune system from that of adult include differences in effector cell subsets, immune-regulatory mechanisms of fetal development, passive acquisition of maternal antibodies, and limited pre-exposure to environmental immune stimuli. These immunologic differences may result in distinct immune responses following infant and adult vaccination. An understanding of the infant immune landscape is therefore critical for the design and selection of vaccines and vaccine adjuvants that will elicit optimal immune responses and target long-term immunity in infants. The workshop goal is to achieve a better understanding of the complex interplay between the maturing immune system and distinct immune responses to HIV and non-HIV vaccines in infants that will not only inform upon prevention strategies to develop efficacious HIV vaccine candidates but may also lead to the identification of correlates of susceptibility to HIV infection and improved animal models to test HIV prevention modalities. The workshop presentations and panel discussions aim to foster collaborative opportunities among experts targeting HIV and non-HIV prevention strategies and to further inform and prioritize vaccine design and immunization approaches for guiding effective and comprehensive HIV prevention efforts in infants.

• To probe the relationship between infant immune landscape and distinct immune responses to HIV and non-HIV vaccines in pediatric populations from that of adults.
• To address the research gaps to understand establishment of adaptive immunity during infancy that results in distinct immune responses in infants following HIV vaccination.
• To determine optimal animal model system(s) to test proof of concept by immune responsiveness of the HIV vaccine candidates in infants.
• To identify avenues to facilitate HIV vaccine design, development, testing, and effectiveness in infants.

Germline Targeting Immunogens: Taking the First Steps toward bNAb Development

12:30 – 15:30
Chicago Ballroom VIII

Host Institutions: International AIDS Vaccine Initiative
Session Chair: William Schief, International AIDS Vaccine Initiative, The Scripps Research Institute
Speakers: William Schief, International AIDS Vaccine Initiative , The Scripps Research Institute; Bart Haynes, Duke University; Andrew McGuire, Fred Hutchinson Cancer Research Center; John Mascola, Vaccine Research Center, NIAID, NIH; Amelia Escolano, The Rockefeller University; Dennis Burton, The Scripps Research Institute; Peter Kwong, Vaccine Research Center, NIAID, NIH

It is becoming more and more evident that unique approaches may be necessary to elicit broadly neutralizing antibodies (bNAbs) against HIV through vaccination. Looking back to understand the germline versions of the antibodies that have been isolated from patients has given the field potential clues as to the way forward. The emerging vaccine strategy of immunizing people with a series of different engineered HIV proteins as immunogens in order to teach the immune system to produce HIV bNAbs from these germline beginnings, has generated a great deal of interest and momentum. To this end, it was recently reported that HIV-1 bNAb precursor B cells for one particular class of bNAbs are present in most people, and that an HIV vaccine germline-targeting immunogen can be designed that is capable of binding those B cells. The recent development of knock-in mouse models with germline bNAb precursor B cells has also opened the door to immunization testing of germline-targeting immunogens and follow-on boosting regimens. With different bNAb targets on the Env protein being investigated by several groups, the field is set for researchers to assess whether other new vaccine proteins can bind and activate their intended precursor B cells, and whether boosting protocols can be devised to mature the response toward bNAb activity. These types of experiments provide the ability to vet germline-targeting and boosting immunogens before testing them in large, time-consuming and costly clinical trials.

Long-acting Drug Release Systems for PrEP and Treatment

12:30 – 15:30

Host Institution: Northwestern University: Sustained Long-Acting Protection from HIV (SLAP-HIV) Program UM1 and the Third Coast Center for AIDS Research
Session Chairs: Craig Hendrix, Johns Hopkins University; Peter Anton, University of California, Los Angeles
Speakers: Rodney Ho, University of Washington: Alessandro Grattoni, Houston Methodist Research Institute; Tejal Desai (represented by William Lykins), University of California, San Francisco; Patrick Kiser, Northwestern University; Meredith Clark, CONRAD, Eastern Virginia Medical School; Bill Spreen, GSK/ViiV

There is currently great interest in increasing antiretroviral adherence by using long-acting drug delivery systems that do not require daily dosing by HAART and PrEP users. These systems will increase adherence to control or prevent HIV infection. Drs. Patrick Kiser and Thomas Hope, co-PIs on the SLAP-HIV UM1, host this workshop to bring together experts in the field to discuss various approaches to sustained release of antiretrovirals including lymphatic delivery, controlled release refillable implant systems, degradable implants, controlled release implants, long-acting intravaginal rings, and injectable nanoformulations. This meeting will have broad appeal to HIVR4P attendees interested in sustained-release PrEP approaches that increase adherence and subsequent protection from HIV acquisition. The workshop’s cross-disciplinary and translational focus will drive innovation, stimulate interactions, and facilitate the exchange of ideas to catalyze the development of sustained release PrEP. In this satellite, six speakers will give 20-minute presentations followed by 5 minutes of discussion.

Target Product Profile for HIV Vaccines

13:00 – 15:00

Host Institution: Global HIV Vaccine Enterprise
Session Chair: Yegor Voronin, Global HIV Vaccine Enterprise
Speakers: James Ackland, International AIDS Vaccine Initiative; Charla Andrews, NIAID; Jane Halpern, National Institute of Allergy and Infectious Diseases, NIH; Dagna Laufer, International AIDS Vaccine Initiative; Sanjay Phogat, sanofi pasteur

Target Product Profile (TPP) is a strategic document that lists key attributes of a candidate vaccine as well as studies required to support the claims. First developed by FDA to facilitate discussions with drug developers, TPP is now widely used in industry to ensure that all team members are working toward common goals and targets. Funders of HIV vaccine R&D are increasingly asking researchers to create TPPs for their vaccine candidates. In this hands-on workshop, product development experts will guide small groups of attendees through creation of TPP for a fictional preventive HIV vaccine candidate. Participants will learn about key elements of TPP, what choices have to be made in prioritizing attributes, and how set targets define the path for product development. Space is limited, advance registration is required for attendance -

Designing Prevention Clinical Trials in the Era of Highly Effective Combination Prevention

13:30 – 15:30
Chicago Ballroom IX

Host Institution: Aaron Diamond AIDS Research Center, University of California, San Francisco
Session Chair: Mitchell Warren, AVAC
Speakers: Susan Buchbinder, San Francisco Department of Public Health; Deborah Donnell, Fred Hutchinson Cancer Research Center; David Glidden, University of California, San Francisco; Jeremy Sugarman, Johns Hopkins University; Timothy Horn, Treatment Action Group

We are at a pivotal moment in HIV prevention where highly effective HIV prevention, particularly PrEP, has been developed but is not yet accessible to the majority of the population in need. Further advance in prevention requires the development of vaccines, alternative oral regimens, and long-acting or coitally dependent dosing strategies. Clinical trials in HIV prevention lack a surrogate, and any efficacy study is a resource-intensive undertaking. The issues of populations in which new agents should be tested, the comparator arms, and the standard package of prevention services present statistical and ethical challenges. This session aims to gather perspectives from clinical investigators, statisticians, ethicists, and community stakeholders on designing efficient and ethical trials for the pipeline of prevention agents.

Implementing HIV/AIDS Combination Interventions Tailored to Populations and Geographies at Scale

9:00 – 11:00
Chicago Ballroom IX

Host Institution: Kenya National AIDS Control Council
Speakers: Nduku Kilonzo, National AIDS Control Council; Chesire Emmy, National AIDS Control Council; Jacobi Jantine, UNAIDS Kenya; Perry Katherine, PEPFAR

The Kenya HIV Prevention Revolution Roadmap (2014) provides a framework for the future orientation of the national HIV prevention response. The Roadmap revolutionized the global HIV response, by recommending that HIV investments be assigned by risk, population, and location profiling. Modelling data demonstrated that the proposed shifts would catalyse reduction of new HIV infections and AIDS-related deaths at no added costs, thus saving lives and averting deaths. The Roadmap recommended shifts in HIV prevention programming at county levels requiring managers to focus on: a) needs of populations rather than driving available interventions blindly toward all populations; b) granulation of the epidemic at sub-national level with appropriate interventions for each sub-epidemic; c) leveraging non-health sector interventions to deliver HIV prevention for hard-to-reach populations and also address structural determinants that drive HIV vulnerability. In the last year, Kenya has made progress in reorienting its HIV program to align to these recommended shifts, which are nontraditional in the HIV response framework globally. Stakeholders including PEPFAR, the Global Fund, and UNAIDS have begun and continue to invest in this approach. This session proposes to share data, experiences, and lessons from global partners and countries in implementing these shifts.

Systems Biology and Vaccines – Implications for HIV Vaccine Design

9:00 – 11:30
Sheraton Ballroom I

Host Institutions: International AIDS Vaccine Initiative and Emory University
Session Chairs: Bali Pulendran, Emory University; Rafick Sekaly, Case Western Reserve University
Speakers: Elias Haddad, Case Western Reserve University; Herbert (Skip) Virgin, Washington University; Bruce Walker, Ragon Institute of MGH, MIT and Harvard; Erica Andersen-Nissen, HVTN; Manjinder Sandhu , Welcome Trust Sanger Institute

Systems biology approaches may help accelerate HIV vaccine development by identifying predictors and genetic signatures of immunogenicity and protective immune responses. Some vaccines appear to be less effective in LMIC populations, with possible factors including nutrition, concomitant infections, and the host microbiome.Systems biology approaches provide an opportunity to understand the impact of these factors on immune response to vaccines for populations most at risk for HIV. Systems biology has been used to identify gene signatures that predict CD8+ T cell and B cell responses to influenza and yellow fever vaccination. However, applications for HIV vaccine development are not well described. This session will review current systems biology methodologies, examples of their use in vaccinology and immunology, and current research relevant to HIV vaccine development. A panel discussion will focus on potential high-priority applications of omics to HIV vaccine development, including microbiome and accompanying bioinformatics.

Beyond Viral Neutralization

9:00 AM – 12:00
Sheraton Ballroom III

Host Institution: Canadian HIV Vaccine Initiative (CHVI) Research and Development Alliance Coordinating Office (ACO), International Centre for Infectious Diseases (ICID, Inc.)
Session Chair: Andrés Finzi, Université de Montréal
Speakers: George Lewis, University of Maryland; Guido Ferrari, Duke University; Marzena Pazgier, University of Maryland; David Evans, University of Wisconsin; Andrés Finzi, Université de Montréal; Nicole Bernard, McGill University; Stylianos Bournazos, Rockefeller University; Matt Parsons, University of Melbourne

It has been known for more than 30 years that Human Immunodeficiency Virus 1 (HIV-1) infection drives a very potent B cell response resulting in the production of anti-HIV-1 antibodies targeting several viral proteins, particularly its envelope glycoproteins (Env), which are exposed at the surface of viral particles and infected cells. Enthusiasm by the generation of these anti-Env antibodies was short-lived since the majority were found to be unable to efficiently neutralize viral particles. This class of antibodies were therefore called non-neutralizing antibodies. However, antiviral activities of antibodies should not be limited to viral neutralization. Through their Fc portion, antibodies can mediate several immunological responses such as antibody-dependent cellular cytotoxicity (ADCC), antibody-mediated complement activation, antibody-mediated cellular phagocytosis (ADCP), antibody-dependent cell-mediated virus inhibition (ADCVI), trancytosis inhibition, opsonization, etc. All these functions could be beneficial in fighting viral infections including HIV-1. In this satellite session, we will discuss the latest developments in the expanding field of non-neutralizing, effector function competent (nNeFC) anti-HIV-1 antibodies.

Sex, Intimacy, and HIV Prevention: What Do Women and Their Partners Really Want? Incorporating End-user Input and Developing a Market Launch Strategy for PrEP

9:00 AM – 12:00
Chicago Ballroom VIII

Host Institution: CONRAD
Session Chair: Andrea Thurman, CONRAD
Speakers: Kristine Torjesen, FHI 360; Ann Kim, IDEO; Jared Baeten, University of Washington; Hasina Subedar, former SANC; Saiqa Mullick, Wits Reproductive Health and HIV Institute; Connie Celum, University of Washington; Yogan Pillay, South Africa Department of Health; Andrew Schirmer, McCann; Liz Montgomery, RTI International; Mitchell Warren, AVAC; Cal Burns, Matchboxology

What do women really desire from an HIV prevention product, and how do we, as a field, provide the optimal environment for women to adopt and adhere to these technologies? What are the product attributes that researchers should incorporate during the development process, and how should they be packaged, branded, and distributed? What role do health care providers, community, and stakeholders play in implementation and uptake? How can private sector approaches be applied to inform public health market shaping? Following the disappointing results of some PrEP trials in African women, one thing is clear: we must begin with the end user in mind. The Microbicide Product Introduction Initiative (MPii) is a multipartner, multiyear project funded by USAID that takes a deep dive into end-user research, stakeholder engagement, and PrEP implementation by using human-centered design, research-driven branding and messaging, and public/private partnerships to engage end users and their network on what makes HIV prevention products desirable and practical to use. Team members from MPii Projects EMOTION, OPTIONS, and POWER will provide an overview of each project and discuss how research and stakeholder engagement will be woven into an integrated launch plan for optimal results in PrEP introduction. Audience engagement will be emphasized.

Strengthening Community Advocacy and Solidarity for HIV Vaccine Research

9:00 AM – 12:00
Sheraton Ballroom II

Host Institution: Vaccine Advocacy Resource Group
Session Chairs: Morenike Upong, New HIV Vaccine and Microbicide Advocacy Society; Tian Johnson, African Alliance for HIV Prevention; Ntando Yola, Desmond Tutu HIV Research Foundation

AIDS vaccine research is complex; the role of an AIDS vaccine advocate is challenging. Explaining the hopeful, yet slow and complicated, progress in AIDS vaccine research to non-scientific stakeholders requires someone with relatively deep knowledge of complex science, research process, and related technical issues. Likewise, the critical role of representing stakeholder concerns to AIDS vaccine researchers requires someone who can speak in language that commands scientists’ attention and respect. Through the Vaccine Advocacy Resource Group (VARG) a global team of AIDS prevention research advocates play a critical liaison role in a highly complex scientific field. Since 2014, the VARG has been convened virtually—largely through teleconferences and email—to receive research updates, discuss advocates’ perspectives and priorities, and to move forward key actions. These efforts have been impactful in terms of coalescing the team of vaccine-specific advocates, building VARG members’ skills and understanding to a certain degree, and preparing them for conferences and scientific meetings. This satellite session aims to build the capacity of community advocates at R4P around HIV Prevention Research Advocacy, particularly how it relates to vaccine research.

Antibody Mediated Prevention and What It Takes to Make an HIV Vaccine?

9:00 AM – 11:00
Chicago Ballroom X

Host Institution: HIV Vaccine Trials Network – FHCRC and HIV Prevention Trials Network—FHI360
Session Chairs: Glenda Gray, South African Medical Research Council; Larry Corey, HIV Vaccine Trials Network
Speakers: Julie McElrath, HIV Vaccine Trials Network; Srilatha Edupuganti, Emory University; Nyaradzo Mgodi, University of Zimbabwe

The HVTN and the HPTN are international collaborations funded primarily by the National Institute of Allergy and Infectious Disease (NIAID) of the United States National Institutes of Health (NIH). Since its founding more than a decade ago, the HVTN has sought to characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing, as rapidly as possible, a safe, effective vaccine for the prevention of HIV infection globally.  The HPTN research agenda is focused primarily on the use of integrated strategies, using antiretroviral therapy for prevention of transmission from the HIV infected individual, and pre-exposure prophylaxis agents for prevention of acquisition in HIV uninfected individuals, as well as interventions for substance use, behavioral risk reduction and structural interventions.  Antibody Mediated Prevention (AMP) is one approach the Networks are taking to achieve these goals. The AMP Studies will demonstrate whether an intravenously infused broadly neutralizing antibody against HIV, which works well in controlled in vitro assays and NHP challenge experiments, will prevent HIV infection in men, women, and transgender individuals at high risk of HIV infection. These studies will also define what levels of neutralizing antibody are required for protection. This satellite session will provide an overview of the AMP Studies, summarize ongoing advances in preclinical work, illustrate experiences implementing the Studies in Africa and in the Americas, and address next steps. This symposium will provide HIV R4P attendees with insight into the challenges and innovations required to move forward in the development of a globally effective HIV vaccine.

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