HVTN MEETING FULL GROUP MAY 14-16, 2018 WASHINGTON D.C.

Transcription

1 HVTN FULL GROUP MEETING MAY 14-16, 2018 WASHINGTON D.C.

2 contents CONTENTS General Information 1 Demonstrations & Hands-on Learning 2 Sunday, May 13 3 Monday, May 14 3 Tuesday, May 15 5 Wednesday, May 16 6 At-a-Glance 10 ClinRegs Fact Sheet 16 Notes 17 Maps Back 2 HVTN FULL GROUP MEETING 2018

3 GENERAL INFORMATION MEETING VENUE The Mayflower Hotel 1127 Connecticut Ave NW Washington D.C Phone: FAX: MEETING REGISTRATION DESK The HVTN registration desk is located in the Promenade Foyer. REGISTRATION HOURS Sunday, May 13 Monday, May 14 Tuesday, May 15 Wednesday, May 16 4:00 pm 7:00 pm 7:00 am 5:00 pm 7:00 am 4:30 pm 7:30 am 10:30 am Check-in: Check-out: 3:00 pm Noon NAME BADGES All registered meeting attendees will be issued a meeting name badge when they check in at the meeting registration desk. Name badges are required for all meeting attendees. Please be sure to wear your name badge at all times when attending meeting-related functions. If you do not have a name badge, or you have lost yours, please return to the meeting registration desk and another badge will be issued. PROGRAM-AT-A-GLANCE For an overview of the meeting program, please refer to the Program-at-a-Glance on pages The sessions are color coded to indicate plenary sessions, open sessions, closed sessions, interpretation, and catering. MEALS Breakfast, lunch, and breaks will be served in the East & State Ballrooms (lobby level), unless you are attending a breakout breakfast or lunch meeting. Buffets will be inside the Palm Court & Chinese Ballrooms A buffet will be set in the 2nd floor foyer near all breakout rooms. Breakfast Morning Break Lunch Afternoon Break Breakfast Morning Break Lunch Afternoon Break MONDAY, MAY 14 7:00 8:30 am 10:00 10:30 am Noon 1:00 pm 2:30 3:00 pm TUESDAY, MAY 15 7:00 8:30 am 10:30 11:00 am 1:00 2:00 pm 4:00 4:30 pm ABOUT SPEAKER CHECK-IN All presenting speakers must check in at the meeting registration desk at least 30 minutes prior to their presentation to hand in their presentation slides, unless they have already done so. Jerry Ockfen-Copeland will be happy to take your presentation slides as well. The AV technician will be available: AV TECHNICIAN HOURS Monday, May 14 Tuesday, May 15 Wednesday, May 16 HVTN OPENING RECEPTION Please join your colleagues in the East & State Ballrooms for an opening night reception with dinner, drinks, and dancing. DJ Dan Goldman will be bringing you the dance hits. HVTN OPENING RECEPTION Monday, May 14 7:00 am 2:30 pm 7:00 am 3:00 pm 7:00 am Noon East & State Ballrooms 7:30 9:30 pm Breakfast Morning Break Lunch WEDNESDAY, MAY 16 PLENARY PRESENTATIONS Grand Ballroom Plenary 1 Plenary 2 Plenary 3 Plenary 4 Plenary 5 Plenary 6 Plenary 7 7:00 8:30 am 10:00 10:30 am Noon 1:00 pm MONDAY, MAY 14 8:30 10:00 am 10:30 am Noon 1:00 2:30 pm TUESDAY, MAY 15 8:30 10:30 am 11:00 am 1:00 pm WEDNESDAY, MAY 16 8:30 10:00 am 10:30 am Noon #HIVVAX Use Twitter hashtag #hivvax to live tweet during the meeting CONFIDENTIALITY: Just a reminder information shared in plenaries and other sessions is confidential. Please note, a majority of the plenary presentation slides will be available on the Members website following the conclusion of the meeting at: HVTN FULL GROUP MEETING

4 ABOUT GENERAL INFORMATION MEETING EVALUATIONS At the conclusion of the meeting, registered participants will be asked to complete a brief online evaluation. The link will be sent to the address you provided at registration. Your feedback is appreciated as it better prepares our Events staff for future meetings. INTERPRETATION SERVICES Infinity Translations will provide Spanish & Portuguese interpretation for all plenaries taking place in the Grand Ballroom as well as those breakout sessions where an asterisk follows the meeting name. Interpretation headsets can be picked up just outside the Grand Ballroom and inside the Palm Court Ballroom. INTERNET ACCESS Wi-Fi LOGIN INFORMATION SSID: Mayflower_Conference Password: HVTN2018 CONFIDENTIALITY TERMS The HVTN is committed to working with a wide variety of industry partners, researchers, and research institutions in the search for an effective, safe vaccine to prevent HIV infection. The HVTN scientific environment must promote frank discussions of vaccine approaches, as well as concerns about safety and effectiveness, to allow the best course of action to be taken. These discussions cannot occur without acknowledging the proprietary nature of the information and its value to our collaborators. The HVTN welcomes industry and research partners and recognizes their concern for keeping information about their products and research approaches confidential. Please read the following statements and select the option which applies to you. By checking one of the options, you are agreeing to the listed terms and conditions. If you have questions, please contact vtn.travel@hvtn.org. DEMONSTRATIONS & HANDS-ON LEARNING HVTN FOR FIRST TIMERS Introduce participants to HVTN network and help with navigating the meeting. FIRST TIMER S BREAKFAST* Monday, May 14 LAYPERSON S LUNCHES The session allows plenary speakers to present their topics in a brief and basic format that is more accessible to non-scientists. LAYPERSON S LUNCH* Monday, May 14 Tuesday, May 15 Palm Court Ballroom Palm Court Ballroom 7:30 8:30am Noon 1:00pm 1:00 2:00pm HVTN JOURNAL CLUB FOR NON-SCIENTISTS: HVTN 104 This will be a journal-club style review of an HVTN primary manuscript for a non-scientist/layperson audience. Ken Mayer and Kelly Seaton will present on HVTN 104. DAIDS GRADING TABLE & ATTRIBUTION TRAINING The purpose of this session is to review changes to the DAIDS Grading Table and review how to correctly assess the potential relatedness of an adverse event to a study product. EVALUATION METRICS HELP DESK Drop by the Evaluation table to ask a question, troubleshoot an issue, or get some tips on how to better meet the metrics and standards used to create the Quarter and Annual Evaluation Reports. CLINICAL CONSIDERATIONS & HIV RISK ASSESSMENTS FOR TRANSGENDER RESEARCH PARTICIPANTS- PILOT TRAINING This is the next training in a series that is being developed by NIAID. This module is targeted to clinical staff at research sites to address clinical considerations and improve skills for risk assessment with transgender participants. MEDIDATA RAVE HELP DESK Assisting site and clinic staff with questions and problems in Medidata Rave and providing best practices, tips, and tricks. SPECIMEN DATA QUALITY CONTROL : THE SDQC TOOL Drop-in Help Desk will include demo, hands-on tutorials and technical support for reviewing and resolving specimen data discrepancies using the HVTN SDQC Tool. Target audience includes site data managers, site processing lab, HIV Diagnostic and specimen repository staff. RAMP SCHOLAR POSTER SESSION HVTN Research and Mentorship Program (RAMP) Scholars will be presenting posters on the research they conducted while based at an HVTN site or laboratory. Learn about the important questions these talented students addressed in their projects on a range of topics in social-behavioral, clinical, and laboratory science areas of the HVTN research agenda. This is a great opportunity to meet this next generation of leaders and learn in-depth about their work! RAMP SCHOLAR POSTER SESSION Monday, May 14 Promenade Foyer 7PM 2 HVTN FULL GROUP MEETING 2018

5 KEY Plenary Session Meals and Breaks Breakout Session Interpretation Provided * SUNDAY, MAY 13 Registration 4:00 7:00pm Grand Promenade MONDAY, MAY 14 Registration 7:00am 5:00pm Grand Promenade BREAKFAST BUFFET 7:00 8:30am East & State Ballrooms S First Timers Breakfast* 7:30 8:30am Palm Court Ballroom Session Chair: S. Wakefield Clinic Coordinator Session 7:30 8:30am Chinese Ballroom Session Chair: Deb Dunbar PLENARY SESSION 1 7:00 8:30am 7:30 8:30am 8:30 10:00am Keeping the Momentum Going* 8:30 10:00am Grand Ballroom Session Chair: Larry Corey, MD Fred Hutch/HVTN MORNING BREAK 10:00 10:30am East & State Ballrooms PLENARY SESSION 2 Data Forum* 10:30 Noon Grand Ballroom Session Chair: Julie McElrath, MD, MPH, PhD Fred Hutch/HVTN HVTN 116: Mucosal Analysis Update 10:30 10:45 Rena Astronomo, PhD & Maria Lemos, MPH, PhD Fred Hutch/HVTN & Fred Hutch/HVTN HVTN 505: Correlates Analyses 10:45 11:00 Georgia Tomaras, PhD & Nicole Frahm, PhD Duke University & Fred Hutch/HVTN Lab HVTN 098: Vaccine Induced Responses 11:00 11:15 Stephen De Rosa, MD Fred Hutch/HVTN Lab What can we learn about bnmabs and vaccines from HIV-1 reservoir and cure studies? 11:15 11:45 John Mellors, MD University of Pittsburgh Questions & Answers 11:45 Noon 10:00 10:30am 10:30 NOON sessions Telling the Story of the AMP Studies 8:30 8:45 Filmmaker: Katie Jennings, New Canoe Media Reporter: Mary Engel, Fred Hutch News Service Moving Forward in a Budget Constricting Time/The Good and the Uncertain for HVTN in :45 9:00 Larry Corey, MD Fred Hutch/HVTN Lab Perspective: Priorities & Issues for HVTN 2018/2019 & Phase 1 Programs 9:00 9:15 Julie McElrath, MD, MPH, PhD Fred Hutch/HVTN Lab SDMC Perspective: Priorities & Challenges for 2018/2019 9:15 9:30 Peter Gilbert, PhD Fred Hutch/SCHARP Questions & Answers 9:30 10:00 LUNCH BUFFET Noon 1:00pm S Layperson s Lunch* Noon 1:00pm East & State Ballrooms Palm Court Ballroom Session chair: Stephaun E. Wallace The layperson s lunches will allow plenary speakers to present their topics in a brief and basic format that is more acessible to non-scientists. Speakers: Barney Graham, MD, PhD & Paul Edlefsen, PhD/Raabya Rossenkhan, PhD HVTN Translational HIV Vaccine ESI Conference Attendee Orientation Lunch Noon 1:00pm HVTN 106 Writing Team Noon 1:00pm Chinese Ballroom Session Chair: Jim Kublin NOON 1:00pm NOON 1:00pm South Carolina Session Chair: Lindsey Baden HVTN FULL GROUP MEETING

6 sessions MONDAY, MAY 14 S How to Complete Lab-Related CRFs Noon 1:00pm Efficacy Trials Working Group Noon 1:00pm PLENARY SESSION 3 NOON 1:00pm New York Session Chair: Jessica Andriesen Rhode Island Session Chairs: Holly Janes, Susan Buchbinder, & Gita Ramjee 1:00 2:30pm Pediatric Vaccine Symposium* 1:00 2:30pm Grand Ballroom Session Chairs: Glenda Gray, MBBCH, FCPAED & Georgia Tomaras, PhD Perinatal HIV Research Unit/South African Medical Research Council/HVTN & Duke University/HVTN Neonatal Immune System/HIV Vaccination Strategy for Infants 1:00 1:20 Christopher Wilson, MD Bill & Melinda Gates Foundation Rationale for Passive Immunization Strategies in Maternal & Infant Populations 1:20 1:30 Barney Graham, MD, PhD NIH: NIAID FDA Considerations for Involving Pregnant Women in HIV Vaccine Trials 1:30 1:40 Jeff Roberts, MD Food & Drug Administration How the Immunology of Long Term Non-Progressors in Children Can Assist in HIV Vaccine Strategies in Infants 1:40 1:50 Phillip Goulder, PhD University of Oxford & Harvard University PLENARY SESSION 3 Panel Discussion: HIV Vaccine Strategies in Infants, Children, and Adolescents for Short Term and Long Term Gain 1:50 2:10 Panel Members: Sharon Nachman, MD, IMPAACT Lynda Stranix-Chibanda, MBCHB, University of Zimbabwe Sallie Permar, MD, PhD, Duke University John Sleasman, MD, Duke University Tony Moody, MD Duke University Amelia Thompson, MD Duke University Questions & Answers 2:10 2:30 AFTERNOON BREAK 2:30 3:00pm East & State Ballrooms 1:00 2:30pm 2:30 3:00pm HVTN 702 Oversight Group Meeting 2:30 4:00pm Pennsylvania Session chair: Carl Dieffenbach S General Community Session* 3:00 5:00pm Palm Court Ballroom Session chair: Gail Broder HVTN Evaluation Metrics Overview & Help Desk 3:00 5:00pm South Carolina Session chair: Jenna Gravley HVTN Investigators Meeting 2:30 4:00pm 3:00 5:00pm 3:00 4:00pm 3:00 4:00pm Chinese Ballroom Session chair: Susan Buchbinder Women s HIV Research Collaborative Informational Session 3:00 4:00pm Virginia Session chair: Michele Andrasik PTL/CSS/MO Meeting 3:00 4:00pm Rhode Island Session chairs: Shelly Karuna & Julia Hutter 3:00 4:30pm 4 Specimen Data Quality Control Breakout Session: The SDQC Tool 3:00 4:30pm New York Session chair: Lauren Young HVTN FULL GROUP MEETING 2018

7 KEY S AMP Assay Planning Plenary Session Meals and Breaks Breakout Session Interpretation Provided * 4:00 5:00pm Virginia Session Chair: Patricia D. Souza Social Behavioral Working Group Meeting 4:00 5:00pm Pennsylvania Session Chair: Michele Andrasik HVTN 112 Writing Team 4:00 5:00pm 4:00 5:00pm Rhode Island Session Chair: Greg Wilson TUESDAY, MAY 15 Registration 7:00 4:30pm Grand Promenade BREAKFAST BUFFET 7:00 8:30am East & State Ballrooms S 7:00 8:30am 7:30 8:30am sessions S US CER Regional Breakout Session 5:00 6:00pm Palm Court Ballroom Session Chair: Gail Broder HVTN Concept Working Group Specimen/Data Science Team Meeting 5:00 6:00pm New York Session Chair: Stephen Walsh HVTN 098 Writing Team 5:00 6:00pm Rhode Island Session Chair: Sri Edupuganti S TB Program 6:00 7:00pm Virginia Session Chair: Jim Kublin RAMP Strategic Planning 6:00 7:00pm New York Session Chair: Jenna Udren RAMP SCHOLAR POSTER SESSION Kareem Alexis: Mixed-methods Study of Experiences Getting PrEP through the HVTN 704/HPTN 083 (AMP Study) PrEP Referral Program Barinaepkee Banuna: Zimbabwean Health Practitioners Knowledge of and Attitudes toward HIV Vaccines and VISP Shay Behrens: Germline-Targeting Vaccine Design for Broadly Neutralizing Abs to the CD4 Supersite of HIV-1 Andrew Braun: Assessing Participant Experience with Intravenous Infusion of Monoclonal Antibody in HVTN 704/HPTN 085 AMP Study Angela Broad White: Using Photo Sharing Platforms for Community Engagement and Recruitment of MSM and Transwomen of Color Czestochowa Francois: Characterization of Human HIV Vaccine-Induced Bone Marrow Plasma Cells HVTN RECEPTION 7:30 9:30pm East & State Ballrooms 5:00 6:00pm 6:00 7:00pm 7:00pm 7:30 9:30pm HVTN 100 Writing Team 7:30 8:30am South Carolina Session Chair: Nicole Grunenberg GeoVax+IHV01+B63 Concept Team 7:30 8:30am Virginia Session Chair: Mike Keefer PLENARY SESSION 4 TB Vaccines* 8:30 10:30am Grand Ballroom Session Chair: Jim Kublin, MD, MPH Fred Hutch/HVTN NIAID TB Vaccine Strategy 8:30 8:50 Sarah Read, MD NIH: NIAID CMV Vector 8:50 9:10 Aurelio Bonavia, PhD Vir Biotechnology BCG in NHP 9:10 9:30 Robert Seder, MD NIH: Vaccine Research Center Pol Study 9:30 9:45 Ann Ginsberg, MD, PhD South African Tuberculosis Vaccine Initiative HVTN 602 Immunogenicity 9:45 10:00 One Dintwe, PhD HVTN Cape Town Immunology Laboratory Correlates Analysis 10:00 10:15 Georgia Tomaras, PhD & Andrew Fiore-Gartland, PhD Duke University & Fred Hutch Questions & Answers 10:15 10:30 8:30 10:30am HVTN FULL GROUP MEETING

8 sessions TUESDAY, MAY 15 MORNING BREAK 10:30 11:00am 10:30 11:00am East & State Ballrooms PLENARY SESSION 5 11:00am 1:00pm Exploring the Use of an escreen Tool to Meet the Needs of Potential HVTN Study Participants 11:50 11:58 John Cullen, PhD University of Rochester Medical School PLENARY SESSION 5 RAMP & HIP Scholars Presentations and HVTN Awards* 11:00am 1:00pm Grand Ballroom Session Chairs: Hyman Scott, MD, MPH, Hong Van Tieu, MD Mixed-methods Study of Experiences Getting PrEP through the HVTN 704/HPTN 083 (AMP Study) PreP Referral Program 11:00 11:05 Kareem Alexis Duke University School of Medicine Zimbabwean Health Practitioners Knowledge of and Attitudes towards HIV Vaccines and VISP 11:05 11:10 Barinaepkee Banuna Stony Brook University School of Medicine Germline-Targeting Vaccine Design for Broadly Neutralizing Abs to the CD4 Supersite of HIV-1 11:10 11:20 Shay Behrens Duke University School of Medicine Assessing Participant Experience with Intravenous Infusion of Monoclonal Antibody in HVTN 704/HPTN 085 AMP Study 11:20 11:25 Andrew Braun University of Texas Health Science Center at San Antonio Using Photo Sharing Platforms for Community Engagement and Recruitment of MSM and Transwomen of color 11:25 11:30 Angela Broad-White, MD University of California San Francisco Characterization of Human HIV Vaccine- Induced Bone Marrow Plasma Cells 11:30 11:40 Czestochowa Francois University of Rochester Medical School Questions & Answers 11:40 11:50 11:00am 1:00pm A Pilot Study of Mobile Technology to Assess Reactogenicity (pmotar) 11:58am 12:06pm Bhavna Maharaj Centre for the AIDS Program of Research in South Africa (CAPRISA) Molecular Analysis of Vaccine-Induced T Cell Responses 12:06 12:14 Mark Pilkinton, MD Vanderbilt University School of Medicine A Pilot Study Evaluating the Use of Novel Self-administered Dried Blood Spot Device - HemaSpot - to Monitor PrEP Use among Men Who Have Sex with Men 12:14 12:22 Magdalena Sobieszczyk, MD, MPH Columbia University Assessing Impact of Vaccine Regimen on Vaccine Induced Antibody Durability 12:22 12:30 Juilee Thakar, PhD University of Rochester Medical Center Questions & Answers 12:30 12:40 HVTN Awards 12:40 1:00 Larry Corey, MD Fred Hutch/HVTN LUNCH BUFFET 1:00 2:00pm East & State Ballrooms S Layperson s Lunch* 1:00 2:00pm 1:00 2:00pm 1:00 2:00pm Palm Court Ballroom Session chair: Gail Broder The layperson s lunches will allow plenary speakers to present their topics in a brief and basic format that is more accessible to non-scientists. Speakers: Magdalena Sobieszczyk, MD, MPH & Bhavna Maharaj 6 HVTN FULL GROUP MEETING 2018

9 KEY S Plenary Session Meals and Breaks Breakout Session Interpretation Provided * PDT-SA Regulatory Strategy Working Group 1:00 2:00pm Pennsylvania Session chair: Mary Ann Luzar BG505 SOSIP + Adjuvants Concept Team 1:00 2:00pm New York Session chair: Julie McElrath Network Evaluation Committee 1:00 3:00pm South Carolina Session chair: Jenna Gravley S 1:00 2:00pm 1:00 3:00pm 2:00 3:00pm HVTN Investigator Data Forum 5:00 6:30pm Grand Ballroom Session chair: Lindsey Baden HVTN 129/HPTN 088 Protocol Team Meeting 5:00 6:30pm Pennsylvania Session chair: Shelly Karuna SGC DINNER 7:30 9:30pm East Ballrooms 5:00 6:30pm 6:30 7:30pm 7:30 9:30pm Scientific Governance Committee Dinner, Invited Guests Only sessions HVTN Journal Club for Non-Scientists: HVTN 104* 2:00 3:00pm Palm Court Ballroom Session chair: Gail Broder PTL/PDM/VTRB Meeting 2:00 3:00pm Chinese Ballroom Session chairs: Cecilia Morgan, Michael Pensiero WEDNESDAY, MAY 16 Registration 7:30 10:30pm Grand Promenade BREAKFAST BUFFET 7:00 8:30am 3:00 4:30pm 7:00 8:30am East & State Ballroom DAIDS Grading Table & Attribution Training 3:00 4:30pm Palm Court Session chair: Archita Chatterjee P5 Executive Committee Meeting 3:00 5:00pm South Carolina Session chairs: Nina Russell & Mary Marovich AFTERNOON BREAK 4:00 4:30pm East & State Ballrooms HVTN Concept Working Group Specimen/Data Scientific Outreach Team Meeting 4:00 5:00pm Chinese Ballroom Session chair: Spyros Kalams CAB Breakout Session* 3:00 5:00pm 4:00 4:30pm 4:00 5:00pm 4:30 6:00pm 4:30 6:00pm Palm Court Ballroom Session chair: Nandi Luthuli S Evaluation Metrics Help Desk 7:30 8:30am South Carolina Session chair: Jenna Gravley HVTN 130/HPTN 089 Protocol Team Meeting 7:30 8:30am Pennsylvania Session chair: Carmen Paez Cross-Protocol Mucosal BAMA Writing Team 7:30 8:30am Rhode Island Session chair: Kelly Seaton PLENARY SESSION 6 7:30 8:30am 8:30 10:00am AMP: The Role of Community Engagement* 8:30 10:00am Grand Ballroom Session Chair: Michele Andrasik, PhD Fred Hutch/HVTN Setting the Stage for Community Engagement 8:30 8:35 Michele Andrasik, PhD Fred Hutch/HVTN Community Engagement Preparation for the AMP Study 8:35 9:00 Gail Broder & Jonathan Lucas Fred Hutch/HVTN & FHi360/HPTN HVTN FULL GROUP MEETING

10 sessions WEDNESDAY, MAY 16 PLENARY SESSION 6 Utilizing Community-Based Participatory Research Methods to Inform Community Engagement 9:00 9:15 Michele Andrasik, PhD Fred Hutch/HVTN Insight Obtained from the AMP Behavioral Study 9:15 9:30 Rafael Gonzalez & Sehar Khalid Bridge HIV & Fenway Community Health Preliminary Exit Interview/Survey Data to Guide the Future 9:30 9:45 Linda Oseso, MPH & Rudy Lott Fred Hutch/HVTN & University of Rochester Questions and Answers 9:45 10:00 MORNING BREAK 10:00 10:30am East & State Ballrooms PLENARY SESSION 7 8:30 10:00am 10:00 10:30am 10:30am NOON PLENARY SESSION 7 Amino Acid Sequence and Phenotypic Sieve Analysis 11:14 11:26 Allan decamp, PhD Fred Hutch/SCHARP Planning for Amino Acid Sequence Sieve Analysis by Analysis of CATNAP 11:26 11:38 Craig Magaret Fred Hutch/University of Washington Timing Is Everything: Estimation of HIV Infection Times 11:38 11:50 Paul Edlefsen, PhD & Raabya Rossenkhan, PhD Fred Hutch & Fred Hutch Questions and Answers 11:50 Noon LUNCH BUFFET Noon 1:00pm Community Wrap-up Session* Noon 1:00pm East & State Ballrooms Palm Court Ballroom Session chair: Gail Broder 10:30am NOON NOON 1:00pm NOON 1:00pm 8 AMP Studies* 11:00am 1:00pm Introduction/Overview 10:30 10:38 Peter Gilbert, PhD Fred Hutch/SCHARP Grand Ballroom Session Chairs: Larry Corey, MD Fred Hutch/HVTN PK Modeling and Correlates of Risk Assessment 10:38 10:50 Yunda Huang, PhD Fred Hutch Neutralizing Data for Correlates and Sieve Analysis 10:50 11:02 Lynn Morris, PhD & David Montefiori, PhD National Institute of Communicable Diseases & Duke University An Overview of the Molecular Analyses in the AMP Trial 11:02 11:14 Jim Mullins, PhD University of Washington RAMP Professional Development Workshop Noon 2:00pm Lab Leadership Meeting Noon 3:00pm AMP All-Site Staff Meeting* NOON 2:00pm Chinese Ballroom Session chair: Jenna Udren NOON 3:00pm Rhode Island Session chair: Nicole Frahm 12:30 2:00pm 12:30 2:00pm Grand Ballroom Session chairs: Carissa Karg, India Tindale, & Shelly Karuna 2:00 3:00pm HVTN 127/HPTN 087 Ops Team Meeting 2:00 3:00pm Virginia Session chairs: Carissa Karg & Phil Andrew HVTN FULL GROUP MEETING 2018

11 KEY S Plenary Session Meals and Breaks Breakout Session Interpretation Provided * 2:00 4:30pm Clinical Considerations & HIV Risk Assessments for Transgender Research Participants-Pilot Training 2:00 4:30pm Palm Court Session chair: Rona Siskind sessions Medidata Rave Help Desk 2:00 5:30pm Palm Court Session chair: Jessica Andriesen 3:00 5:00pm PAB/CRPMC & CRS Pharmacists Training 3:00 5:00pm Chinese Ballroom Session chair: Ruth Ebiasah 4:00 7:00pm Retention Workshop for Efficacy Trials 4:00 7:00pm Grand Ballroom Session chair: Gail Broder HVTN FULL GROUP MEETING

12 at-a-glance TIME 7:00am 7:30am 8:00am MONDAY, MAY 14 GRAND PROMENADE FOYER PALM COURT HVTN for First Timers* (7:30-8:30am) CHINESE Clinic Coordinator Meeting (7:30-8:30am) EAST Breakfast Buffet (7:00-8:30am) STATE 8:30am 9:00am Plenary 1: Keeping the Momentum Going* 9:30am (8:30-10:00am) 10:00am Morning Break (10:00-10:30am) 10:30am 11:00am 11:30am 12:00pm 12:30pm Plenary 2: Data Forum* (10:30am - Noon) Registration (7am-5pm) Layperson s Lunch* (Noon - 1:00pm) HVTN Translational HIV Vaccine ESI Conf. Orientation (Noon - 1:00pm) Lunch Buffet (Noon - 1:00pm) 1:00pm 1:30pm Plenary 3: Pediatric Vaccine Symposium* 2:00pm (1:00-2:30pm) 2:30pm Afternoon Break (2:30-3:00pm) 3:00pm 3:30pm 4:00pm General Community Session* (3:00-5:00pm) HVTN Investigators Meeting (3:00-4:00pm) 4:30pm 5:00pm 5:30pm U.S. CER Regional Breakout Session (5:00-6:00pm) 6:00pm 6:30pm 7:00pm 7:30pm RAMP & HIP Scholar Poster Session (7:00-8:00pm) 8:00pm HVTN Reception 8:30pm (7:30-9:30pm) 9:00pm 9:30pm 10 HVTN FULL GROUP MEETING 2018

13 Plenary Session Meals and Breaks Registration Live Streaming Session Session Off Agenda Interpretation SOUTH CAROLINA VIRGINIA PENNSYLVANIA NEW YORK RHODE ISLAND * NEW HAMPSHIRE TIME 7:00am 7:30am 8:00am at-a-glance 8:30am 9:00am 9:30am 10:00am 10:30am 11:00am 11:30am HVTN 106 Writing Team (Noon - 1:00pm) How to Complete Lab-Related CRFs (Noon - 1:00pm) Efficacy Trials Working Group (Noon - 1:00pm) 12:00pm 12:30pm 1:00pm 1:30pm 2:00pm HVTN Evaluation Metrics Overview & Help Desk (3:00-5:00pm) Women s HIV Research Collaborative (3:00-4:00pm) AMP Assay Planning (4:00-5:00pm) TB Program (6:00-7:00pm) HVTN 702 Oversight Group Meeting (2:30-4:00pm) Social Behavioral Working Group Meeting (4:00-5:00pm) SDQC Breakout Session: The SDQC Tool (3:00-4:30pm) HVTN CWG Specimen/Data Science Team Mtg (5:00-6:00pm) RAMP Strategic RAMP Planning Strategic Planning (6:00-7:00pm) PTL/CSS/MO Meeting (3:00-4:00pm) HVTN 112 Writing Team (4:00-5:00pm) HVTN 098 Writing Team (5:00-6:00pm) 2:30pm 3:00pm 3:30pm 4:00pm 4:30pm 5:00pm 5:30pm 6:00pm 6:30pm 7:00pm 7:30pm 8:00pm 8:30pm 9:00pm 9:30pm HVTN FULL GROUP MEETING

14 at-a-glance TIME 7:00am 7:30am 8:00am TUESDAY, MAY 15 GRAND PROMENADE FOYER PALM COURT CHINESE EAST Breakfast Buffet (7:00-8:30am) STATE 8:30am 9:00am 9:30am Plenary 4: TB Vaccines* (8:30-10:30am) 10:00am 10:30am Morning Break (10:30-11:00am) 11:00am 11:30am 12:00pm 12:30pm Plenary 5: RAMP & HIP Scholar Presentations/ HVTN Awards* (11:00am - 1:00pm) Registration (7am-4:30pm) 1:00pm 1:30pm Layperson s Lunch* (1:00-2:00pm) Lunch Buffet (1:00-2:00pm) 2:00pm 2:30pm HVTN Journal Club for Non-Scientists: HVTN 104* (2:00-3:00pm) PTL/PDM/VTRB Meeting (2:00-3:00pm) 3:00pm 3:30pm 4:00pm 4:30pm 5:00pm 5:30pm HVTN Investigator Data Forum DAIDS Grading Table & Attribution Training (3:00-4:30pm) CAB Breakout Session* (4:30-6:00pm) HVTN CWG Specimen/Data Scientific Outreach (4:00-5:00pm) Afternoon Break (4:00-4:30pm) 6:00pm (5:00-6:00pm) 6:30pm 7:00pm 7:30pm 8:00pm SGC Dinner (Invite Only) 8:30pm 9:00pm (7:30-9:30pm) 9:30pm 12 HVTN FULL GROUP MEETING 2018

15 Plenary Session Meals and Breaks Registration Live Streaming Session Session Off Agenda Interpretation SOUTH CAROLINA HVTN 100 Writing Team (7:30-8:30am) VIRGINIA PENNSYLVANIA NEW YORK GeoVax + IHV01 + B63 Concept Team (7:30-8:30am) RHODE ISLAND * NEW HAMPSHIRE TIME 7:00am 7:30am 8:00am at-a-glance 8:30am 9:00am 9:30am 10:00am 10:30am 11:00am 11:30am 12:00pm 12:30pm Network Evaluation Committee Meeting (1:00-3:00pm) PDT-SA Regulatory Strategy Working Group (1:00-2:00pm) BG505 SOSIP + Adjuvants Concept Team (1:00-2:00pm) 1:00pm 1:30pm 2:00pm 2:30pm 3:00pm P5 Executive Committee Meeting (3:00-5:00pm) 3:30pm 4:00pm 4:30pm 5:00pm 5:30pm 6:00pm HVTN 129/HPTN 088 Protocol Team Meeting (6:30-7:30pm) 6:30pm 7:00pm 7:30pm 8:00pm 8:30pm 9:00pm 9:30pm HVTN FULL GROUP MEETING

16 at-a-glance TIME 7:00am 7:30am 8:00am 8:30am 9:00am 9:30am WEDNESDAY, MAY 16 GRAND Plenary 6: AMP: The Role of Community Engagement* (8:30-10:00am) PROMENADE FOYER Registration (7:30-10:30am) PALM COURT CHINESE EAST Breakfast Buffet (7:00-8:30am) STATE 10:00am Morning Break (10:00-10:30am) 10:30am 11:00am 11:30am Plenary 7: AMP Studies* (10:30a - Noon) 12:00pm 12:30pm 1:00pm 1:30pm AMP All-Site Staff* (12:30-2:00pm) Community Wrap-Up Session* (Noon - 1:00pm) RAMP Professional Development Workshop (Noon - 2:00pm) Lunch Buffet (Noon - 1:00pm) 2:00pm 2:30pm 3:00pm 3:30pm 4:00pm 4:30pm 5:00pm 5:30pm 6:00pm Retention Workshop for Efficacy Trials (4:00-7:00pm) Clinical Considerations & HIV Risk Assessments for Transgender Research Participants- Pilot Training (2:00-4:30pm) PAB/CRPMC & CRS Pharmacists Session (3:00-5:00pm) 6:30pm 7:00pm 7:30pm 8:00pm 8:30pm 9:00pm 9:30pm 14 HVTN FULL GROUP MEETING 2018

17 Plenary Session Meals and Breaks Registration Live Streaming Session Session Off Agenda Interpretation SOUTH CAROLINA Evaluation Metrics Help Desk (7:30-8:30am) VIRGINIA PENNSYLVANIA NEW YORK HVTN 130/HPTN 089 Protocol Team Meeting (7:30-8:30am) RHODE ISLAND Cross Protocol Mucosal BAMA Writing Team (7:30-8:30am) * NEW HAMPSHIRE TIME 7:00am 7:30am 8:00am at-a-glance 8:30am 9:00am 9:30am 10:00am 10:30am 11:00am 11:30am 12:00pm 12:30pm Lab Leadership Meeting 1:00pm Medidata Rave Help Desk HVTN 127/HPTN 087 Ops Team Meeting (2:00-3:00pm) (Noon - 3:00pm) 1:30pm 2:00pm 2:30pm 3:00pm (2:00-4:30pm) 3:30pm 4:00pm 4:30pm 5:00pm 5:30pm 6:00pm 6:30pm 7:00pm 7:30pm 8:00pm 8:30pm 9:00pm 9:30pm HVTN FULL GROUP MEETING

18 An online database of country-specific regulatory information *Additional countries will be added based on NIAID s research priorities Easy-to-Read Regulatory Information Planning a clinical trial? ClinRegs offers country-specific regulatory information in a simple format. Links to Official Documents Want to learn more? ClinRegs links to the official documents used to develop the country profiles. English Translations Working in a non-english speaking country? ClinRegs provides links to translations of official documents when available. Compare Regulatory Requirements Conducting research in another country? Quickly view country requirements sideby-side using our comparison tool. Get Involved Heard about a regulatory update? Submit updates or comments and we will validate and update the information on the site. Stay in the Know Want to be notified about updates? Sign up for ClinRegs updates to hear about changes to the regulatory information. clinregs.niaid.nih.gov Last Reviewed/Updated: March 19, 2018

19 HVTN FULL GROUP MEETING NOTES

20 THE MAYFLOWER HOTEL The HVTN Full Group Meeting will convene throughout he first and second floors of The Mayflower Hotel. If you need additional assistance, an attendant at the Registration Desk will be happy to assist you. FIRST FLOOR DESALES STREET THOMAS PINK SENATE ROOM CABINET ROOM CONNECTICUT AVE RESTROOMS FRONT DESK STAIR ELEVATORS CONCIERGE DESK STATE ROOM COAT ROOM EAST ROOM PROMENADE ELEVATOR FOYER 17TH STREET PALM COURT GRAND CHINESE ROOM Y LOBBY LEVEL SECOND FLOOR DELAWARE BOARDROOM GEORGIA MARYLAND MASSACHU- SETTS ELEVATORS VIRGINIA ELEVATOR FOYER RESTROOMS FOYER NEW HAMPSHIRE 17TH STREET SOUTH CAROLINA NEW JERSEY CONNECTICUT AVE SOUTHWEST C RHODE ISLAND PENNSYL- VANIA NORTH CAROLINA NEW YORK SECOND FLOOR