Proposal for Workshop on Adjuvants and Adjuvanted Preventive and Therapeutic Vaccines for Infectious Disease Indications
Two-day session, 2-3 December 2008
This is a two-day workshop, co-sponsored by CBER/FDA and NIAID/NIH to 1) assess the scientific knowledge base regarding vaccine adjuvants, 2) identify gaps in our knowledge and ability to evaluate vaccine adjuvants and adjuvanted vaccines, and 3) facilitate the implementation of a global research agenda to address the identified gaps and improve the safety and efficacy assessments of adjuvanted vaccines for the treatment and prevention of infectious disease. The target audience and participants include academia, government researchers, government regulators, the WHO, vaccine clinical trial experts and industry representatives. The format includes short presentations to be followed by a round table discussion. Presentations will identify common themes, issues and approaches; discussions will synthesize research goals and priorities and address potential regulatory and product development solutions.
Day 1:
Introduction and Welcome
Anthony Fauci, M.D. (NIH)
Jesse Goodman, M.D. (FDA)
| 8:40 – 9:00 |
Introduction and welcome |
Session 1: Background
Speakers and Co-chairs: Norman Baylor, Ph.D. (CBER, FDA) and Dan Rotrosen, M.D. (NIAID, NIH)
Objectives for session: introduce reasons for the workshop, sponsors, format, issues to be addressed, scientific/regulatory environment.
| 9:00 – 9:30 |
Introduce goals/specific objectives of workshop, review the specific questions to be addressed in the roundtable discussions to be held before and after session 4 on day 2 |
Session 2: SPECIFIC ADJUVANTS OVERVIEW
Speakers and Co-chairs: Bali Pulendran, Ph.D. (Emory Vaccine Center) and Elizabeth Sutkowski, Ph.D. (CBER, FDA)
Objectives for session: Discuss the immunobiology of adjuvants in relation to immune activation and potential untoward effects of immune activation. Discussion to include mechanisms (where known), animal data and in vitro data, and formulation issues.
| 9:30-9:40 |
The co-chairs will provide the objectives (above) of the session, and a very brief introduction to the multiple types of vaccine adjuvants to be considered and their many targets/mechanisms of action.
Speakers: Bali Pulendran, Ph.D. (Emory) and Elizabeth Sutkowski Ph.D. (CBER/FDA) |
| 9:40-10:05 |
Activation of the NLRP3-inflammasome by vaccine adjuvants
Speaker: Fabio Re, Ph.D. (University of Tennessee) |
| 10:05-10:45 |
Effects of first generation adjuvants on the immune system and how the molecular properties of these adjuvants affect their adjuvant activity
| 10:05-10:25 |
Generation one adjuvants, including emulsions, microparticles and liposomes
Speaker: Derek O’Hagan, Ph.D. (Novartis) |
| 10:25-10:45 |
Saponins, ISCOMs and ISCOMATRIX adjuvant
Speaker: Eugene Maraskovsky, Ph.D. (CSL Ltd.) | |
| 10:45-11:10 |
Effects of adjuvants which act via Toll-like receptors (TLRs); responses by innate immune cells in animal studies and in vitro and their biological manifestations.
Speaker: Bruce Beutler, M.D. (Scripps Research Institute) |
| 11:10-11:30 |
COFFEE BREAK |
| 11:30-11:55 |
Adjuvants development: lessons learned.
Speaker: Nathalie Garcon, Ph.D. (GlaxoSmithKline) |
| 12:20-12:45 |
Cross-talk between TLRs and CLRs, and their roles in modulating the balance between Th17/Th1 and T regulatory responses.
Speaker: Bali Pulendran, Ph.D. (Emory Vaccine Center) |
| 12:45-2:15 |
LUNCH |
Session 3: PRECLINICAL SAFETY
Co-chairs: Ethan Shevach, M.D. (NIAID, NIH) and Marion Gruber, Ph.D. (CBER, FDA)
Objectives for session: Discuss established and novel approaches to preclinical studies important to support clinical trials.
| 2:15-2:30 |
Current FDA approaches: a brief overview of current non-clinical testing requirements for adjuvants/adjuvanted vaccines.
Speaker: Marion Gruber, Ph.D. (CBER, FDA) |
| 2:30-2:45 |
Current EMEA approaches: a brief overview of current non-clinical testing requirements for adjuvants/adjuvanted vaccines.
Speaker: Jan Willem van der Laan, Ph.D. (National Institute of Public Health and the Environment) |
| 2:45-3:10 |
Uses and limitations of animal models: overview of current animal models towards demonstrating risks and benefits of adjuvants.
Speaker: Carl Alving, M.D. (Walter Reed Army Institute of Research) |
| 3:10-3:35 |
Long term effects of adjuvants: consequences on the adaptive response—enhancement of beneficial T and B cell responses and triggering autoimmunity. Specifically address whether non-conventional animal models (i.e. those prone to autoimmunity) may be of value to predict potential adverse events in susceptible humans.
Speaker: Ethan Shevach, M.D. (NIAID, NIH) |
| 3:35-3:55 |
COFFEE BREAK |
| 3:55-4:45 |
Design of preclinical studies: effects of dosage and dosing regimen
| 3:55-4:20 |
Speaker: Sarah Gould, Ph. D. (Sanofi Pasteur) |
| 4:20-4:45 |
Speaker: Deborah Novicki, Ph.D. (Novartis) | |
| 4:45-5:10 |
VaxDesign’s in vitro mimic of the immune system for evaluating adjuvants
Speaker: William Warren, Ph.D. (VaxDesign) |
| 5:10-5:30 |
Speaker: Hana Golding, Ph.D. (CBER/FDA) |
End of Day 1
DAY 2:
| 8:00-9:30 |
Round Table Discussion: Industry, Academics, FDA, and NIH speakers will discuss Day 1 material and relevant questions |
|
| Participants |
Carl Alving, M.D.
Bruce Beutler, M.D.
Martin Friede, Ph.D. (WHO)
Nathalie Garcon, Ph.D.
Hana Golding, Ph.D.
Sarah Gould, Ph.D.
Marion Gruber, Ph.D.
Eugene Maraskovsky, Ph.D.
Deborah Novicki, Ph.D.
Derek O’Hagan, Ph.D. |
Fabio Re, Ph.D.
Robert Seder, M.D.
Ethan Shevach, M.D.
Elizabeth Sutkowski, Ph.D.
Sandra Morel (GSK)
Geert van den Bossche, Ph.D., D.V.M. (Gates Foundation)
Jan Willem van der Laan, Ph.D.
William Warren, Ph.D. | |
Session 4: CLINICAL
Co-chairs: Jay Slater, M.D. (CBER, FDA) and W. Ripley Ballou. M.D. (Gates Foundation)
Objectives for session: Manufacturers will be invited to make brief balanced presentations on their experiences in designing, implementing and interpreting clinical studies of their adjuvanted vaccines. Special emphasis will be placed on approaches to evaluating safety as well as effectiveness.
| 9:30-9:50 |
Introduction of session and brief remarks
Speaker: W. Ripley Ballou, M.D. (Gates Foundation) |
| 9:50-10:10 |
MF59 Adjuvant: results from pooled safety analysis in over 33,000 subjects
Speaker: Giovanni della Cioppa, M.D. (Novartis) |
| 10:10-10:30 |
Facing the Clinical Development Challenges for CSL Limited's proprietary ISCOMATRIX® adjuvant
Speaker: Charmaine Gittleson, M.D. (CSL) |
| 10:30 -10:50 |
Leishmaniasis Vaccine: Clinical Experience with MPL-SE
Speaker: Steve Reed, Ph.D. (IDRI) |
| 10:50-11:10 |
COFFEE BREAK |
| 11:10-11:30 |
Clinical experience testing CPG 7909 TLR9 agonist as a vaccine adjuvant
Speaker: Heather Davis, Ph.D. (Pfizer) |
| 11:30-11:50 |
Evaluation of Vaccines Using New Adjuvant Systems
Speaker: Gary Dubin, M.D. (GSK) |
| 11:50-12:10 |
LT patch
Speaker: Greg Glenn, M.D. (Intercell) |
| 12:10 -12:30 |
Designing, implementing and interpreting clinical studies of adjuvanted vaccines
Speaker: Martine Denis (Sanofi Pasteur) |
| 12:30 – 1:30 |
LUNCH |
| 1:30 -2:10 |
Compare and contrast innate immunity/clinical experience with adjuvanted vaccines in the early and late stages of life:
| 1:30 -1:50 |
Distinct innate immunity of human newborns: implications for the development of neonatal and infant vaccine adjuvants
Speaker: Ofer Levy M.D., Ph.D. (Children’s Hospital Boston & Harvard Medical School) |
| 1:50-2:10 |
MF59 Adjuvant: immunogenicity results in different age ranges
Speaker: Rino Rappuoli, Ph.D. (Novartis) | |
| 2:10- 3:40 |
Round Table Discussion Industry, Academics, FDA, and NIH speakers will discuss clinical study design issues, use of in vitro data. |
|
| Participants: |
Norman Baylor, Ph.D.
Ripley Ballou, M.D.
Heather Davis, Ph.D.
Giovanni della Cioppa, M.D.
Martine Denis
Gary Dubin, M.D.
Martin Friede, Ph.D.
Charmaine Gittleson, M.D.
Gregg Glenn, M.D. |
Marion Gruber, Ph.D.
Thomas Holdich, MB.BS (ATL)
Ofer Levy, M.D. Ph.D.
Douglas Pratt, M.D.
Rino Rappuoli, Ph.D.
Steve Reed, Ph.D.
Dan Rotrosen, M.D.
Jay Slater, M.D.
Thomas Verstraeten, M.D., M.Sc. (GSK) | |
| 3:40-4:00 |
COFFEE BREAK |
| 4:00 – 5:00 |
Session 6: Wrap up
Speakers: Hana Golding, Ph.D. (CBER, FDA); Chuck Hackett, Ph.D. (NIAID, NIH) |
| 5:00 |
Adjourn |
back to top