investigators meeting...breakfast, morning break, lunch, and afternoon break will be served in the...

#HIVVAX

HVTNINVESTIGATORS MEETING

NOVEMBER 6th - 7th

HVTN INVESTIGATORS MEETING 2018

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General Information

Demonstrations

Sunday, November 4th

Monday, November 5th

Tuesday, November 6th

Wednesday, November 7th

Notes

At-A-Glance

Maps

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CONTENTS

HVTN INVESTIGATORS MEETING 2018 1

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MEETING VENUEGrand Hyatt Seattle 721 Pine Street Seattle, WA 98101

Phone: 206.774.1234 www.grandseattle.hyatt.com

MEETING REGISTRATION DESKThe HVTN registration desk will be located in the Princessa Foyer adjacent to the Portland A meeting room.

NAME BADGESAll registered attendees will be issued a name badge when they check in. 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 registration desk and another badge will be issued.

SPEAKER CHECK-INAll presenting speakers must check in at the registration desk at least 30 minutes prior to their plenary session to hand in their presentation slides, unless they have already done so. The AV technician will be available:

HVTN WELCOME RECEPTION Please join your colleagues in the Leonesa & Princessa Foyers for a welcome reception with dinner, and drinks.

PROGRAM-AT-A-GLANCEFor an overview of the meeting program, please refer to the Program-At-A-Glance on pages 8 — 13. The sessions are color coded to indicate plenary sessions, general sessions, breakout sessions, and catering.

MEALSBreakfast, morning break, lunch, and afternoon break will be served in the Leonesa Foyer with seating in the Princessa Ballrooms. If you are attending a breakfast or lunch session there will be a buffet in or near your meeting room, including on the 7th floor.

GENERAL SESSIONSLeonesa Ballrooms

DINNER SESSIONLeonesa Ballrooms

Please note, a majority of the plenary presentation slides will be available on the Members website following the conclusion of the meeting at:

https://members.hvtn.org/hvtn-conference/SitePages/November-2018-

HVTN-Investigators.aspx

Use Twitter hashtag #hivvax to live tweet during the meeting

**Members Site Confidentiality Reminder for all HVTN Investigators Meeting Sessions**The information included in Investigators Meeting presentations is considered confidential. As an HVTN member, you have signed an agreement covering confidentiality which prevents you from sharing the information with others except as permitted in writing by the HVTN.

Please DO NOT take pictures of any slides during any presentation.

Check-in: 4:00pmCheck-out: Noon

GENERAL INFORMATION

REGISTRATION HOURS






AV TECHNICIAN HOURS

HVTN WELCOME RECEPTION

Monday, Nov 5th

Breakfast

Framing Talks8:30 – 9:30am

7:00 – 9:00pm

Immediate & Future Impacts on Operations8:30am – Noon

Case Study 1: Experimental Medicine Trial11:00am – 12:30pm

Maximizing Publication Productivity3:30 – 4:15pm

Breakfast

Monday, Nov 5th

Monday, Nov 5th

Wednesday, Nov 7th

Lunch

Coffee Break

Dinner Session

Box Lunches

Wednesday, Nov 7th

Tuesday, Nov 6th

Morning Break

Data Forum9:30 – 10:30am

Case Study 2: Innate Immunity & the Immune Response Landscape

1:30 – 3:00pm

Streamlining Enrollment in Phase 1 Vaccine Studies4:15 – 5:00pm

Tuesday, Nov 6th

Afternoon Break

7:00am – 7:30pm

7:00 – 8:30am

7:00 – 8:30am

7:00am – 4:00pm

6:30 – 8:30pm

7:30am – 12:30pm

12:30 – 1:30pm

5:00 – 5:15pm

7:00 – 9:00pm

12:00 – 1:00pm

7:00am – Noon

7:00am – 3:30pm

10:30 – 11:00am

7:00am – 5:30pm

Leonesa & Princessa Foyers

3:00 – 3:30pm

#HIVVAX

Vision for the bnAb Program5:15 – 6:00pm

Phase 1 Concept/Studies Under Development: A Debate on Their Relative Ranking for Implementation


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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 email address you provided at registration. Your feedback is appreciated as it better prepares our Events staff for future meetings.

INTERPRETATION SERVICESThere will be no interpretation services at this meeting.

INTERNET ACCESSWireless internet service is available for all meeting attendees.

LIVE-STREAMINGFor those of you who cannot attend the HVTN Investigators Meeting this year, we will be streaming the General Sessions LIVE. If you miss the live feed, recordings of the General Sessions will also be available. You will be able to access the streaming plenaries (on the members site) by visiting:

https://members.hvtn.org/hvtn-conference/SitePages/LiveStream.aspx

Video Password: #HVTN2018

Please remember these video presentations are confidential and not to be shared. Plan to use Chrome, Firefox, or Microsoft Edge as these are the only browsers that will support the video provided.

DATASPACE DEMONSTRATION TABLEDemonstration of the CAVD DataSpace for HVTN Investigators

DEMONSTRATIONS

DataSpace Demonstration Table

Monday, Nov 5th 12:30 – 6:30pm

Leonesa Foyer

Tuesday, Nov 6th 12:15 – 6:30pm

GENERAL INFORMATION

Wi-Fi LOGIN INFORMATION

Password: HIVVAX2018

SSID: Hyatt Meetings


Meals and BreaksKEY Live Streaming General Session Breakout SessionSE

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Open Registration for the HIV Prevention Efficacy Trials Symposium & the HVTN Investigators Meeting 4:00 – 7:00pm Princessa Foyer

Open Registration for the HIV Prevention Efficacy Trials Symposium & the HVTN Investigators Meeting 7:00am – 7:30pm Princessa Foyer

Open Registration 7:00am – 3:30pm Princessa Foyer

7:00 – 8:30am Leonesa Foyer

6:30 – 8:30pm Leonesa & Princessa FoyersContinued on the next page...

HIV Prevention Efficacy Trials Symposium 8:30 am – 5:45pm Leonesa Ballrooms

Stakeholder Discussion for Future Efficacy Trials Design Planning

7:00 – 8:30am Stevens, 7th floor Closed Session chair: S. Wakefield

Framing Talks8:30 – 9:30am Leonesa Ballrooms Session Chair: Glenda Gray, MBBCH, FCPAED Perinatal HIV Research Unit, South African Medical Research Council, HVTN

Historical Review of First 130 HVTN Vaccine Studies 8:30 – 9:00am Larry Corey, MD and Troy Martin, MD, MPHFred Hutch/HVTN and Fred Hutch/HVTN

Examples of Success: A DNA Trial (HVTN 106) & A Protein Trial (HVTN 111)9:00 – 9:30am Jim Kublin, MD, MPH and Nina Russell, MDFred Hutch/HVTN and Bill & Melinda Gates Foundation

Data Forum9:30 – 10:30am Leonesa Ballrooms Session Chair: Julie McElrath, MD, MPH, PhD Fred Hutch/HVTN Lab

Recent Findings in Mosaic Vaccine Studies: HVTN 117 & HVTN 106 9:30 – 9:45am Stephen de Rosa, MDFred Hutch/HVTN Lab

Impact of Late Boosting in MVA or DNA/MVA Regimens: HVTN 1149:45 – 10:00am Kelly Seaton, PhDFred Hutch/HVTN Lab

HIV PREVENTION EFFICACY TRIALS SYMPOSIUM

BREAKFAST BUFFET 7:00 – 8:30am

HVTN WELCOME RECEPTION 6:30 – 8:30pm

BREAKOUT SESSION 7:00 – 8:30am

SESSION 1 8:30 – 9:30am

SESSION 2 9:30 – 10:30am

8:30am – 5:45pm

SUNDAY NOV 4th

MONDAY, NOV 5th

TUESDAY, NOV 6th

HIV Prevention E�cacy Trial Designs of the Future November 5, 2018


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Data Forum9:30 – 10:30am Leonesa Ballrooms Session Chair: Julie McElrath, MD, MPH, PhD Fred Hutch/HVTN Lab

Vaccine-Induced ADCC Activities in South African Recipients: Comparative Analysis of HVTN 097 vs. HVTN 100 10:00 – 10:15 Guido Ferarri, MDDuke University/HVTN LC

Questions & Answers10:15 – 10:30

Case Study 1- Experimental Medicine Trial11:00am – 12:30pm Leonesa Ballrooms Session Chair: Jim Kublin, MD, MPH Fred Hutch/HVTN

What Is an Experimental Medicine Trial? How Do We Do This? 11:00 – 11:30am Barton Haynes, MD and William Schief, PhDCHAVI/Duke University and CHAVI/Scripps

Phase 1 Design11:30 – 11:40amLeo Stamatatos, PhDFred Hutch

What Is an Experimental Medicine Trial? How Do We Do This? 11:40 – 11:50amDan Barouch, MD, PhDHarvard University

Defining Germline Endpoints: What Is a Successful Neutralization Profile?11:50am – 12:20pm Kristen Cohen, PhD, David Montefiori, PhD, and Youyi Fong, PhDFred Hutch/HVTN Lab, Duke University/HVTN Lab, and Fred Hutch/Vaccine & Infectious Disease

Questions & Answers12:20 – 12:30pm

Case Study 2- Innate Immunity & the Immune Response Landscape1:30 – 3:00pm Leonesa Ballrooms Session Chair: Julie McElrath, MD, MPH, PhD Fred Hutch/HVTN Lab

Innate Immunity 1:30 – 1:40pm Julie McElrath, MD, MPH, PhDFred Hutch/HVTN Lab

What Is the Innate Signature for an HIV Vaccine?1:40 – 1:55pm Erica Andersen-Nissen, PhDHCRISA/Cape Town HVTN Immunology Laboratory

Multivariate Immune Response Landscaping1:55 – 2:05pm Andrew Fiore-Gartland, PhDFred Hutch/SCHARP

MetaVis, A User-Friendly Interface for Visual Exploration of Immunological Data2:05 – 2:10pm Michael ZhaoFred Hutch/Vaccine & Infectious Diseases

Discussion on the Use of Transcriptional Arrays and Other Techniques Useful for Defining the Innate Response2:10 – 2:40pm Galit Alter, PhD and John Tsang, PhDHarvard University and National Institute of Health/NIAID


Maximizing Publication Productivity3:30 – 4:15pm Leonesa Ballrooms Session Chair: Georgia Tomaras, PhD Duke University/HVTN

Current Status of HIV Publications 3:30 – 3:50pm Ann Duerr, MD, PhD and Ashley ClaytonFred Hutch/HVTN

How and Why to Maximize Publication Productivity: A Proposal3:50 – 4:10pm Georgia Tomaras, PhD and Larry Corey, MDDuke University/HVTN and Fred Hutch/HVTN

SESSION 2, CONTINUED 9:30 – 10:30am

SESSION 3 11:00am – 12:30pm

SESSION 4 1:30 – 3:00pm

SESSION 5 3:30 – 4:15pm

MORNING BREAK 10:30 – 11:00am

AFTERNOON BREAK 3:00 – 3:30pm

LUNCH BUFFET 12:30 – 1:30pm

10:30 – 11:00am Leonesa Foyer

3:00 – 3:30pm Leonesa Foyer



Meals and BreaksKEY Live Streaming General Session Breakout SessionSE

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Streamlining Enrollment in Phase 1 Vaccine Studies4:15 – 5:00pm Leonesa Ballrooms Session Chair: Susan Buchbinder, MD Bridge HIV/HVTN

Phase 1 Enrollment Needs and Challenges 4:15 – 4:25pm Susan Buchbinder, MDBridge HIV/HVTN

A Perspective From DAIDS4:25 – 4:30pmDale Hu, MDNational Institute of Health/DAIDS

Panel Discussion4:30 – 5:00pm Panelists to join Susan and Dale: Mary Marovich, MD, National Institute of Health/DAIDSMary Allen, RN, National Institute of Allergy & Infectious Diseases/DAIDSStephen Walsh, MD, Harvard UniversityMagdalena Sobieszczyk, MD, MPH, Columbia UniversityJulia Hatter, MD, Vaccine Clinical Research Branch at NIH

Immediate & Future Impacts on Operations8:30am – 12:00pm Leonesa Ballrooms Session Chair: Troy Martin, MD, MPH Fred Hutch/HVTN

Community Engagement: Update from the Atlanta Conference 8:30 – 9:00am Michele Andrasik, PhDFred Hutch/HVTN

Research with Us, Not on Us – HVTN Legacy9:00 – 9:30amS. WakefieldFred Hutch/HVTN

Defining Sieving & Time of Acquisition in AMP: New Dimensions in Real Time Molecular Assays9:30 – 10:30amPeter Gilbert, PhDFred Hutch/SCHARP

Joining Peter:David Montefiori, PhD, Duke UniversityJim Mullins, PhD, University of WashingtonPaul Edlefsen, PhD, Fred HutchDan Reeves, PhD, Fred Hutch

Follow-up to HVTN 705 in MSM 10:30 – 11:00am Susan Buchbinder, MD and Larry Corey, MDBridge HIV/HVTN and Fred Hutch/HVTN

Vision for the bnAb Program5:15 – 6:00pm Leonesa Ballrooms Session Chair: Magdalena Sobieszczyk, MD, MPH Columbia Univeristy

Panel Discussion 5:15 – 6:00pm Panelists: Shelly Karuna, MD, MPH, Fred Hutch/HVTNDavid Montefiori, PhD, Duke UniversityCarmen Paez, MD, Fred Hutch/HVTN

Phase 1 Concept/Studies Under Development: A Debate on Their Relative Ranking for Implementation7:00 – 9:00pm Princessa Ballrooms Dinner Session Session Chair: Larry Corey, MD

Fred Hutch/HVTN


SESSION 5, CONTINUED 3:30 – 4:15pm

SESSION 6 4:15 – 5:00pm

SESSION 9 8:30am – 12:00pm

SESSION 7 5:15 – 6:00pm

SESSION 8 7:00 – 9:00pm

COFFEE BREAK 5:00 – 5:15pm


Open Registration 7:30am – 12:30pm Princessa Foyer

BREAKFAST BUFFET 7:00 – 8:30am

WEDNESDAY, NOV 7th

P5 Executive Committee Meeting

7:30 – 8:30am Discovery Closed Session chair: Jim Lane NIH/NIAID

BREAKOUT SESSION 7:30 – 8:30am

Continued on the next page...


Live Streaming General Session Meals and Breaks Breakout SessionKEYSE

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Immediate & Future Impacts on Operations8:30am – 12:00pm Leonesa Ballrooms Session Chair: Troy Martin, MD, MPH Fred Hutch/HVTN

Symposium Summary 11:00 – 11:30am Peter Gilbert, PhD, Fred Hutch/SCHARPKenneth Mayer, MD, Fenway HealthLinda-Gail Bekker, MBCHB, DTMH, DCH, FCP, PhD, Desmond Tutu HIV Foundation

Summary & Closing11:30am – 12:00pmLarry Corey, MDFred Hutch/HVTN

SESSION 9, CONTINUED 8:30 – NOON

BOX LUNCHES 12:00 – 1:00pm

12:00 – 1:00 pm Leonesa Foyer

HVTN Efficacy Trials Statisticians Meeting

12:00 – 1:00pm Portland A Closed Session chair: Holly Janes, PhD Fred Hutch/SCHARP

HVTN Laboratory Leadership Meeting

12:00 – 4:00pm Discovery Closed Session chair: Julie McElrath, MD, MPH, PhD Fred Hutch/HVTN Lab

BREAKOUT SESSION 12:00 – 1:00pm

BREAKOUT SESSION 12:00 – 4:00pm


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HIV Prevention Efficacy Trials Symposium

(8:30am - 5:45pm)

Open Registration

(7:00am-7:30pm)

MONDAY, NOV 5th


(12:30 – 6:30pm)

HVTN WELCOME RECEPTION Symposium Closing Reception

(6:30 — 8:30pm)


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Breakfast Buffet

(7:00 — 8:30am)

Morning Break(10:30 — 11:00am)

Session 1: Framing Talks

(8:30 – 9:30am)

Session 2: Data Forum

(9:30 – 10:30am)

Session 3: Case Study 1 - Experimental

Medicine Trial

(11:00 am – 12:30pm)

Session 4: Case Study 2 - Innate

Immunity & the Immune Response Landscape

(1:30 – 3:00pm)

Session 5: Maximizing Publication Productivity

(3:30 – 4:15pm)

Session 6: Streamlining Enrollment in Phase 1

(4:15 – 5:00pm)

Session 7: Vision for the bnAb Program

(5:15 – 6:00pm)

Session 8: Phase 1 Concept/Studies

Under Development: A Debate on Their Relative

Ranking for Implementation

Dinner Session

(7:00 – 9:00pm)

Open Registration

(7:00am – 3:30pm)

TUESDAY, NOV 6th


(12:15 – 6:30pm)

Lunch Buffet(12:30 — 1:30pm)

Afternoon Break(3:00 — 3:30pm)

Coffee Break (5:00 — 5:15pm)

Dinner Session

7:00am

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Session 9: Immediate & Future

Impacts on Operations

(8:30 – Noon)

Open Registration

(7:30am – 12:30pm)

WEDNESDAY, NOV 7th

Box Lunches(Noon — 1:00pm)

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P5 Executive Committee Meeting

(7:30 – 8:30am)

HVTN Efficacy Trials Statisticians Meeting

(Noon – 1:00pm)

HVTN Laboratory Leadership Meeting

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The HVTN Investigators Meeting will convene throughout the lobby level, and seventh floors of the Grand Hyatt. All meeting spaces can be accessed through the Princessa Foyer. Please refer to the map to locate specific meeting rooms. If you need additional assistance, an attendant at the Registration Desk will be happy to assist you.

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investigators meeting...breakfast, morning break, lunch, and afternoon break will be served in the...

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