Organized by ReSViNET 4th RESVINET CONFERENCE ON RSV THERAPEUTICS

RSV Vaccines for the World

November 29th – December 1st, 2017 Malaga, Spain

ORGANIZING COMMITTEE

Janet Englund – Chair Children's Hospital & Medical Center, Seattle, United States Asuncion Mejias – Chair The Research Institute At Nationwide Children's Hospital, Columbus, United States Leyla Kragten-Tabatabaie, ReSViNET Network Manager Julius Clinical, Zeist, The Netherlands Louis Bont, ReSViNET Chairman Wilhelmina Children’s Hospital University Medical Center Utrecht, Utrecht, The Netherlands Tessa Kliest, ReSViNET Network Associate Julius Clinical, Zeist, The Netherlands Natalie Mazur, Young Researchers Program Associate Wilhelmina Children’s Hospital University Medical Center Utrecht, Utrecht, The Netherlands Aline Veurink-Westrik, ReSViNET Network Associate Julius Clinical, Zeist, The Netherlands

WELCOME

Dear friends and colleagues,

We are delighted to welcome you to Malaga and the 3rd RSV Vaccines for the World

Conference organized by ReSViNET. The program features a range of sessions,

including more than 90 posters, designed to ensure maximum opportunity for

interaction and audience participation. We are thrilled that many young researchers

and experts from low and middle income countries have found their way to attend this

meeting. To maximize interaction with young researchers, we have organized a

masterclass by Barney Graham and a young researcher’s tournament.

Our faculty will lead a topical program developed by the Steering Committee and

focusing on the latest aspects of RSV vaccine development and beyond. The program is

broken down in eight session themes including: burden of RSV disease and mortality,

RSV structure, antibodies, vulnerable populations, surveillance, current status of

vaccine development, correlates of protection and long-term sequelae associated with

RSV. We selected the most innovative abstract submissions by manufacturers for oral

lectures in session 6. Every session concludes with a panel discussion in which we

encourage you to participate. Three distinct poster sessions will be held to ensure that

you are exposed to the most recent discoveries and ongoing research and have the

opportunity to speak directly with investigators.

We anticipate an exciting scientific event that will expand our knowledge of RSV and

disseminate new findings in vaccine development. We look forward to your active

participation to make this event a success.

Yours sincerely, Asuncion Mejias Janet Englund Louis Bont

PROGRAM | DAY 1 WEDNESDAY 29 NOVEMBER

10:00 – 12:30 12:30 – 13:30

ReSViNET Board members Meeting (at AC Hotel) Lunch *Only for ReSViNET board members

12:00 – 17:00 Registration and badge retrieval at Albeniz Cinema

WELCOME AND OPENING (at Albeniz Cinema)

15:45 – 16:00 16:00 – 16:15 16:15 – 16:45

Welcome by ReSViNET (Louis Bont & Leyla Kragten) Opening by meeting chairs (Asuncion Mejias & Janet Englund) Keynote Lecture: RSV F structural biology for beginners: antigenic sites and epitopes (Jason McLellan)

Session I RSV BURDEN AND INFANT MORTALITY (at Albeniz Cinema)

16:45 – 17:00 17:00 – 17:20 17:20 – 17:40 17:40 – 18:00 18:00 – 18:20 18:20 – 18:30

Session introduction, identifying gaps and aims of session (Chair: Fernando Polack/Johan Vekemans) RSV Burden: Global mortality (Harish Nair) The burden of RSV community mortality in India (Ashish Satav) The burden of RSV community mortality and how to tackle it (Fernando Polack) Perspective on WHO’s priorities on RSV prevention and data for policy (Johan Vekemans) General round table discussion

18:30 – 19:30 YOUNG RESEARCHERS TOURNAMENT (This session is open to all) Inne Nauwelaers Annelies Leemans Thomas C. Williams Richard Chawana

20:00 Welcome Drinks and Tapas (at Picasso Museum)

SPEAKERS DAY 1 | DAY 1 WEDNESDAY 29 NOVEMBER

Jason McLellan Biochemistry and Cell Biology, Geisel School of Medicine, Dartmouth, United States Fernando Polack Fundación Infant, Buenos Aires, Argentina

Harish Nair Usher Institute Of Population Health Sciences & Informatics, The University Of Edinburgh Medical School, Edinburgh, United Kingdom Johan Vekemans Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland Ashish Satav MAHAN Trust Organisation, Mahatma Gandhi Tribal Hospital, Utavali, India

Young Researchers Tournament Inne Nauwelaers PhD Candidate at Imperial College London London, United Kingdom Annelies Leemans PhD Candidate at University of Antwerp, Belgium Thomas C. Williams PhD Candidate at University of Edinburgh, United Kingdom Richard Chawana Post-doc at RMPRU Wits Univ, South Africa

Session II VIRUS STRUCTURE AND VACCINE DESIGN (at Albeniz Cinema)

08:30 – 08:40 08:40 – 09:05 09:05 – 09:30

09:30 – 09:50 09:50 – 10:15 10:15 – 10:30

Session introduction, identifying gaps and aims of session (Chair: Barney Graham/Ruth Karron) Viral Fusion Proteins: Structure-Guided Vaccine Antigen Design (Barney Graham) Lessons from post-vaccination RSV surveillance to inform future live-attenuated RSV vaccine trials (Ruth Karron) Live RSV vaccine candidates attenuated by M2-2 or NS2 deletion are well-tolerated and immunogenic in RSV seronegative children and infants(Ulla Buchholz) Accelerating Vaccine Development (Deborah Higgins) Interactive round table discussion with the speakers

10:30 – 11:30

Coffee/Tea break and Poster session I (at Estudiantes) Abstract categories: Vaccines, Clinical Studies and Trials

Session III RSV ANTIBODIES: ARE THEY THE MAIN SURROGATE OF PROTECTION? (at Albeniz Cinema)

11:30 – 11:45 11:45 – 12:05 12:05 – 12:25 12:25 – 12:45 12:45 – 13:00

Session introduction, identifying gaps and aims of session (Chair: Helen Chu/ Pedro A. Piedra) Transplacental antibody transfer: does time matter? (Helen Chu) Is it pre F, post F or G? (Jose Melero) What is the threshold of protection? (Pedro A. Piedra) Interactive round table discussion with the speakers

13:00 – 14:30 Lunch (at Patio Las Beatas)

Session IV RSV IN VULNERABLE POPULATIONS (at Albeniz Cinema)

14:30 – 14:40 14:40 – 15:00 15:00 – 15:20 15:20 – 15:40 15:40 – 15:50

Session introduction, identifying gaps and aims of session (Chair: Janet Englund/Octavio Ramilo) RSV burden in preterm infants (Anne Greenough) RSV in immunocompromised patients (Janet Englund) Human volunteer challenge and RSV vaccines for adults: what role could there be? (Peter Openshaw) Interactive round table discussion with the speakers

15:50 – 16:45

Coffee/Tea break and Poster session II (at Estudiantes) Abstract categories: Basic Science and Translational Studies

Session V RSV SURVEILLANCE AND GUIDELINES (at Albeniz Cinema)

16:45 – 16:50 16:50 – 17:10 17:10 – 17:30 17:30 – 17:50 17:50 – 18:10 18:10 – 18:30 18:45 – 19:45

Session introduction, identifying gaps and aims of session (Chair: Asuncion Mejias/Eugenio Baraldi) Guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of RSV disease (Mair Powell, EMA) WHO Guidelines and international standards for regulatory evaluation of RSV vaccines and mabs (Ivana Knezevic, WHO) RSV surveillance in the United States (Susan Gerber, CDC) Introduction of WHO RSV surveillance strategy and update on the surveillance pilot (Siddhivinayak Hirve, WHO) Interactive round table discussion with the speakers YOUNG RESEARCHERS EXPERT WORKSHOP (only for registered young researchers to attend)

19:30 – 20:00 20:00 – 23:00 23:00 – 23:30

Gather in front of AC hotel for bus Shuttles to Palacio Miramar Dinner (at Palacio Miramar) Taking bus Shuttles back to AC hotel

PROGRAM | DAY 2 THURSDAY 30 NOVEMBER

SPEAKERS | DAY 2 THURSDAY 30 NOVEMBER

Barney Graham Viral Pathogensis Laboratory And Translational Science Core & National Institute Of Allergy And Infectious Diseases, Bethesda, United States Ruth Karron Johns Hopkins Bloomberg School of Public Health, Baltimore, United States Ulla Buchholz Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, United States Deborah Higgins PATH - Center for Vaccine Innovation and Access, Seattle, United States Helen Chu University Of Washington, Washington, United States Jose Melero Department Respiratory viruses, Instituto de Salud Carlos III, Madrid, Spain Pedro A. Piedra Baylor College Of Medicine, Texas, United States Anne Greenough MRC & Asthma UK Centre for Allergic Mechanisms in Asthma, Department of Women and Children’s Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King’s College London, London, UK Janet Englund Children's Hospital & Medical Center, Seattle, United States Peter Openshaw Faculty Of Medicine, National Heart & Lung Institute, Imperical College London, London, United Kingdom Mair Powell Chair EMA Vaccine Working Party; Member EMA Infectious Disease Working Party and Scientific Advice Working Party, London, United Kingdom Ivana Knezevic Department of Essential Medicines and Health Products, World Health Organization, Geneva, Switzerland Susan Gerber Division of Viral Diseases, Centers for Disease Control and Prevention (CDC), Atlanta, United States Siddhivinayak Hirve Global Influenza Program World Health Organization, Geneva, Switzerland

PROGRAM | DAY 3 FRIDAY 1 DECEMBER

Session VI

Part 1

STATUS OF VACCINE DEVELOPMENTS (at Albeniz Cinema)

08:30 – 08:35

08:35 – 09:00

09:00 – 09:15

09:15 – 09:30

09:30 – 09:45

Session introduction, identifying gaps and aims of session (Chair: Ann Falsey/Edward Walsh)

History and future of RSV vaccines (Edward Walsh)

RSV G protein as an antibody and vaccine target (Larry Kauvar, Trellis Biosciences)

Safety, immunogenicity and efficacy of a molecularly adjuvanted adenovirus 5-based RSV vaccine

in cotton rats (Roberto Mateo, Vaxart Inc.)

MEDI8897, an extended half-life RSV neutralizing monoclonal antibody (Anis Khan, MedImmune)

09:45 – 11:00

Coffee/Tea break and Poster session III (at Estudiantes) Abstract categories: Epidemiology and Modeling

Session VI

part 2

STATUS OF VACCINE DEVELOPMENTS (at Albeniz Cinema)

11:00 – 11:15

11:15 – 11:30

11:30 – 11:45

11:45 – 12:00

12:00 – 12:15

Session introduction (Chair: Ann Falsey/ Edward Walsh)

A phase II safety and immunogenicity trial of RSV f vaccine in adults ≥ 60 years (Vivek Shinde,

Novavax)

Safety and immunogenicity of a phase 1 study in older adults (Benoit Callendret, Janssen)

Confirmed safety and broad immunogenicity of MVA BN RSV vaccine in ≥ 55 year old adults

(Nathaly Samy, Bavarian Nordic)

Interactive round table discussion with the speakers

Session VII SURROGATE MARKERS OF VACCINE EFFICACY: SEROLOGY AND BEYOND (at Albeniz

Cinema)

12:15 – 12:20

12:20 – 12:40

12:40 – 13:00

13:00 – 13:20

13:20 – 13:30

Session introduction, identifying gaps and aims of session (Chair: Peter Openshaw /Marta Nunes)

Predictors to immune responses to vaccination in young infants (Octavio Ramilo)

Clinical endpoints in trials of RSV vaccines in pregnant women: study design issues, assessment

of safety and effectiveness (Marta Nunes)

Immune response to vaccines in the older adults (Ann Falsey)

Round Table Discussion with the speakers

13:30 – 14:45 Lunch (at Market de la Merced)

Session VIII RSV AND LONG-TERM SEQUELAE (at Albeniz Cinema)

14:45 – 15:00

15:00 – 15:20

15:20 – 15:40

15:40 – 16:00

16:00 – 16:15

16:15 – 16:25

16:25 – 16:35

Session introduction, identifying gaps and aims of session (Chair: Louis Bont/Renato Stein)

Lessons learned from Immunoprophylaxis RCTs (Eric Simoes)

The epidemiological link between RSV and asthma – Follow-up in RSV Vaccine Trials: how long is

enough? (Louis Bont)

Interactive round table discussion with the speakers

Announcement Winner Young Researchers Tournament (Natalie Mazur/Barney Graham)

Wrapping up meeting (Asuncion Mejias & Janet Englund)

Closing Remarks by ReSViNET (Louis Bont and Leyla Kragten)

SPEAKERS | DAY 3 FRIDAY 1 DECEMBER

Edward Walsh School of Medicine and Dentistry, University of Rochester Medical Center, Rochester, United States Larry Kauvar Trellis Biosciences, Menlo Park, United States Roberto Mateo Vaxart Inc., South San Franscisco, United States Anis Khan MedImmune, Gaithersburg, United States Vivek Shinde Novavax Inc., Gaithersburg, United States Benoit Callendret Janssen Vaccines, Leiden, The Netherlands Nathaly Samy Bavarian Nordic, Munich, Germany Octavio Ramilo Center For Vaccines And Immunity, Nationwide Children's Hospital, Columbus, United States Marta Nunes University Of Witwatersrand, Johannesburg, South Africa & Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa Ann Falsey University Of Rochester Medical Center, New York, United States Renato Stein Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil Eric Simoes Pediatrics-Infectious Diseases, Children's Hospital Colorado, Colorado, United States Louis Bont Wilhelmina Children’s Hospital University Medical Center Utrecht, Utrecht, The Netherlands

LOCATION

The conference will take place in the Spanish city Málaga. Málaga is a city on the Mediterranean in South Spain and the heart of the Costa del Sol. The vibrant cosmopolitan city of Málaga is situated on the beautiful Andalucía coastline. Blessed with sunshine, Málaga provides lively nightlife, museums and exceptional seafood restaurants alongside wide boulevards, swaying palm trees and beautiful beaches. Guests can enjoy the beautiful and quiet seaside, visit the Picasso museum and Picasso’s birth house, walk through the small and picturesque streets in the historic centre and have the possibility to encounter Antonio Banderas, who is the pride of the city.

VENUE & ACCOMODATION

RSV Vaccines for the World 2017 will be held in the heart of the Spanish city Málaga, in Cine Albéniz. Cine Albéniz is an old characteristic cinema which is located in the historic centre of Málaga next to the roman theatre which was built in the 1st century AD and the Alcabaza castle which was built in order to protect the city from its enemies. We would like to recommend the AC Hotel Malaga Palacio. From the conference center it takes 3 minutes by foot to arrive at AC Hotel Malaga Palacio. The hotel is located in the center of a shopping area, in the vicinity of Museo Automovilistico De Malaga, Museum of Malaga and Malagueta Beach.

RSVVW ‘17 does not have an arrangement with AC Hotel Malaga Palacio, bookings can be made through their website.

1. Albeniz Cinema – Conference hall Calle Alcazabilla, 4, 29015 Málaga 2. Coffee Breaks – Estudiantes Calle Alcazabilla, 3, 29015 Málaga 3. Welcome Cocktail – Picasso’s Museum Calle San Agustín, 8, 29015 Málaga

4A. Lunch Thursday – Patio las Beatas Calle Beatas, 43, 29006 Málaga 4B. Lunch Friday – Merced Market Calle Gómez Pallete, 12, 29012 Málaga 5. Dinner – Palacio Miramar Calle Monte Miramar, 38, 29016 Málaga 6. AC Hotel Calle Cortina del Muelle, 1, 29015 Málaga

WHERE TO GO

ACKNOWLEDGEMENTS

Platinum Supporters*

Gold Supporters*

Silver Supporters

*Limited availability

The Organising Committee and the Board of ReSViNET would like to express gratitude and acknowledge the following companies and institutes for their generous support of the RSV Vaccines for the World conference 2017, organised by ReSViNET.

Bronze Supporters

YOUNG RSV RESEARCHERS TOURNAMENT

PARTICIPATION PhD students, post-docs, medical residents or certified specialists (with no more than 3 years practice since completing training or PhD) are eligible to apply. Eligible candidates may indicate that they wish to participate in the tournament when submitting an abstract. Written confirmation from the head of a candidate’s department about resident or PhD status has to be provided and submitted to info@resvinet.org. SELECTION OF CANDIDATES The Organizing Committee will select 4 candidates to participate in the tournament on the basis of the abstract content. FINANCIAL SUPPORT The conference registration fee will be waived for candidates who are selected for the tournament.

PRESENTATION Each candidate is allotted 10 minutes for presentation of his or her research and 5 minutes to answer questions from the jury. The presentations will take place on the first evening of the conference, November 29, 2017. EVALUATION Candidates will be judged on (1) the scientific value of the work presented, (2) the quality of the oral presentation, and (3) the quality of responses to the jury. PRIZE The winner of the tournament will receive a prize consisting of free registration, accommodation as well as a travel grant for the ReSViNET 5th meeting in 2019. The prize is not transferable and will not be paid off in cash.

SCIENTIFIC ADVISORY COMMITTEE

Ruth Karron Johns Hopkins Bloomberg School of Public Health, Baltimore, United States Leyla Kragten-Tabatabaie Julius Clinical, Zeist Asuncion Mejias The Research Institute At Nationwide Children's Hospital, Columbus, Ohio, United States Harish Nair Usher Institute Of Population Health Sciences &Informatics & The University Of Edinburgh Medical School, Edinburgh, United Kingdom Marta Nunes University Of Witwatersrand, Johannesburg, South Africa & Chris Hani Baragwanath Academic Hospital, Johannesburg, South Africa Peter Openshaw Faculty Of Medicine, National Heart & Lung Institute, Imperical College London, London, United Kingdom Pedro A. Piedra Baylor College Of Medicine, Texas, United States

Louis Bont Wilhelmina Children’s Hospital University Medical Center Utrecht, Utrecht, The Netherlands Helen Chu University Of Washington, Washington, United States Janet Englund Children's Hospital & Medical Center, Seattle, United States Ann Falsey University Of Rochester Medical Center, New York, United States Barney Graham Viral Pathogensis Laboratory And Translational Science Core & National Institute Of Allergy And Infectious Diseases, Bethesda, United States Deborah Higgins RSV Vaccine Project at Path, Seattle, Washington, United States

RESVINET SITES & PARTNERS

WHY JOIN US? CONTINUE FOCUSING ON

DEVELOPING RSV THERAPIES AND VACCINES

REACH ACADEMIC LEADERS AND TOP SCIENTISTS IN THE FIELD

NETWORKING WHILE WORKING

CUTTING-EDGE SCIENTIFIC RESEARCH

OPPORTUNITIES FOR FUTURE INTERNATIONAL COLLABORATION

We wish all participants a pleasant stay in Malaga during our RSV Vaccines for the World conference. If you have any questions or require additional information, please contact us: t +31 (0)6 11331391 e info@resvinet.org

w www.resvinet.org

5th ReSViNET Conference November 2019

Utrecht, The Netherlands

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