2015 Archived Content

Cambridge Healthtech Institute’s 10th Annual
Novel Vaccines
Part One: Adjuvants
August 24-25

Many recently developed vaccines are comprised of recombinant molecules or subunits of pathogenic organisms, requiring formulation with adjuvants to increase and direct the immune response. The benefit of adjuvants is clear: they may reduce the amount of antigen and number of vaccinations needed, accelerate the immune response, increase cross-protection, and improve efficacy in populations that are poor responders. As we continue to confront emerging and re-emerging disease threats and progress toward developing new vaccines to improve global health, there is also an urgent need for the development of novel adjuvants. CHI’s Tenth Annual Novel Vaccines: Adjuvants meeting will cover the latest advances in a range of adjuvants, from archaeosomes to TLRs, present case studies of successful formulations against challenging diseases, and address issues related to regulatory approval and understanding mode of action.

Day 1 | Day 2 | Download Brochure | Speaker Biographies
UD: Unpublished Data | CS: Case Study

Recommended Dinner Short Course*
Targeting the Cancer Mutanome
*Separate registration required


7:15 am Registration & Morning Coffee


8:10 Chairperson’s Opening Remarks

Nathalie Garçon, Ph.D., Pharm.D., CSO, Bioaster


Derek O’Hagan, Ph.D., Global Head, Vaccine Chemistry and Formulation Research, GlaxoSmithKline

Rapid progress in molecular immunology has advanced vaccine adjuvant discovery efforts, enabling the use of cellular and target-based assays to screen large collections of chemical compounds for potential use as immune potentiators. However, the question remains as to how to safely and effectively deliver these new adjuvant compounds, particularly for use in existing vaccines. Here we describe a novel approach to enable recently discovered adjuvant active compounds called Small Molecule Immune Potentiators (SMIPs) to adsorb to aluminum hydroxide adjuvant via the mechanism of ligand exchange.

9:00 Novel Archaeal Lipid-Based Semi-Synthetic Adjuvants for Induction of Cell-Mediated Immunity

Lakshmi Krishnan, Ph.D., Program Leader, Vaccines, and Team Leader, Human Health Therapeutics, National Research Council, Canada

Archaeosomes, prepared from isoprenoid lipids extracted from archaea, have immuno-modulator and antigen carrier properties. Semi-synthetic archaeosome adjuvants comprise an archaeal core lipid precursor from which a series of glyco-archaeol and phospho-archaeol adjuvants are derived. Adjuvant formulations can be selected to induce a potent antibody, cell-mediated (Th1/CD8 T cells) and/or mucosal immunity. Archaeosomes act through a TLR-independent receptor mediated activation of dendritic cells, thus representing safe and potent novel adjuvants.

9:30 Coffee Break


10:00 The Use of a Novel Nanoemulsion Adjuvant for Both Prophylactic and Therapeutic Intranasal Vaccination

Ali_FattomAli Fattom, Ph.D., Senior Vice President, Vaccine R&D, NanoBio

Nanoemulsion (NE) adjuvanted gD2/gB2 was prepared and tested intranasally (IN) in a guinea pig model for both prophylactic and therapeutic vaccination. In the prophylactic study, the IN NE-gD2/gB2 vaccine showed greater protection than the IM MPL/Alum gD2 control and prevented virus latency in 11 out of 12 animals vaccinated. In the therapeutic study, the IN NE-gD2/gB2 vaccine reduced the mean cumulative recurrent lesion scores by 64% compared to the non-vaccinated control group (p=0.006). These studies indicate the possibility of using an IN NE vaccine as both a prophylactic and therapeutic vaccine against genital herpes.

UD_Icon10:30 Novel and Effective Adjuvants for Vaccines against Viruses or Tumors

Jung Huang, Ph.D., Professor, Biochemistry and Molecular Biology, Saint Louis University School of Medicine

Alum adjuvant has very limited value in the development of many potential vaccines against viruses or tumors. Lymphatic entry of immune cells is known to be an important rate-limiting step in primary immunity to viruses or tumor cells. We have developed novel peptide adjuvants which promote vaccine potency by inducing opening of lymphatic-intercellular junctions and enhancing migration or transit of immune cells from the interstitial space into lymphatic vessels and lymph nodes. Novel adjuvants we developed potentiate efficacy of commercially available vaccines and herpes simplex virus type 2 (HSV-2) experimental vaccine.

11:00 FDA Perspective: Regulatory Considerations in the Safety Assessment of Vaccine Adjuvants and Adjuvanted Vaccines

Carmen M. Collazo-Custodio, Ph.D., Microbiology & Primary Reviewer, Vaccines & Related Product Applications, CBER, FDA

The Office of Vaccines Research and Review (OVRR) is responsible for the regulatory review of Investigational New Drug Applications and Biologics License Applications for preventive and therapeutic vaccines for infectious disease indications. This presentation will provide an overview of key components in the nonclinical (product characterization as well as pharmacology and toxicology evaluation) and the clinical safety assessment of investigational vaccines regulated by OVRR, with a focus on vaccines with novel adjuvants.

11:30 Self-Emulsifying Adjuvants: A Novel Simplified Approach to Generate Emulsion Droplets for Adjuvant Use

Ruchi Shah, GlaxoSmithKline Vaccines; Department of Pharmaceutical Sciences, Northeastern University

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own


1:25 Chairperson’s Remarks

Lynda Tussey, Ph.D., CSO, VaxInnate

Shan_Lu1:30 DNA Vaccination at the Crossroads of Acquired and Innate Immunities

Shan Lu, M.D., Ph.D., Professor, Medicine, University of Massachusetts Medical School

The use of DNA immunization to elicit high quality antibody responses is receiving more attention. DNA prime-protein boost is highly effective in eliciting cross-subtype binding and functional antibodies in both animal and human studies. New data demonstrated that DNA immunization can take advantage of recently identified intracellular mechanisms involved in both acquired and innate immune response pathways.

2:00 Engineered Forms of the TLR5 Agonist, Flagellin, Support Highly Immunogenic Subunit Vaccines

Lynda Tussey, Ph.D., CSO, VaxInnate

VaxInnate’s vaccine platform supports potent vaccines that can be produced rapidly at low cost and high volume. The platform is based on the genetic fusion of flagellin, a Toll-Like Receptor 5 agonist, to an antigen of choice. The chimeric proteins produced comprise the signals necessary for the induction of robust adaptive immune responses. We have developed a library of engineered forms of flagellin with demonstrated enhanced performance in the clinic. The potential mechanisms underlying these improvements will be discussed along with applications of the platform to our dengue and influenza vaccine programs.

2:30 Nanoliposome Combination Adjuvant Containing QS-21 and a Synthetic TLR4 Ligand

Quinton Dowling, Process Development Specialist, Infectious Disease Research Institute

QS-21 is purified from Quillaja saponaria and has been demonstrated to have potent adjuvant properties when formulated appropriately. However, the purification process and hemolytic activity of unformulated QS-21 are some of the challenges in making it available for vaccine applications. We successfully purified and incorporated QS-21 into a stable liposomal formulation containing a synthetic TLR4 ligand. We developed a method of producing a proprietary formulation of the adjuvant and demonstrated its potent immunogenicity when combined with recombinant vaccine antigens in various preclinical models. This combination adjuvant has now been produced at IDRI under cGMP conditions for use in Phase I clinical trials.

3:00 Refreshment Break


3:30 Mode of Action of Adjuvant System AS01

Arnaud Didierlaurent, Ph.D., Director, Translational Research & Adjuvant, GlaxoSmithKline Vaccines

The mode of action of Adjuvant System AS01, a liposome-based vaccine adjuvant containing both monophosphoryl lipid A (MPL) and the saponin QS-21, will be described. AS01 is used in several candidate vaccines including the RTS,S malaria and zoster candidate vaccines.

4:00 Effect of Formulation and Particle Size on Stability and Immunogenicity of Oil-in-Water Emulsion Adjuvants

Vidyashankara Iyer, Ph.D., Scientist, Formulation Sciences, MedImmune


4:30 De-Risking Formulation Design

Roger_BrookesRoger H. Brookes, Ph.D., Bioprocess R&D, Sanofi Pasteur

Understanding the relevant biological activity of any pharmaceutical formulation destined for human use is crucial. For vaccine-based formulations, activity must reflect the expected immune response, while for non-vaccine therapeutic agents, such as monoclonal antibodies, a lack of immune response to the formulation is desired. The following presentation discusses the human whole blood (hWB) approach as a valuable new tool to de-risk manufacture, formulation design, and clinical progression.

5:00 End of Day

Day 1 | Day 2 | Download Brochure | Speaker Biographies
UD: Unpublished Data | CS: Case Study


7:25 am Morning Coffee


7:55 Chairperson’s Opening Remarks

Ali Fattom, Ph.D., Senior Vice President, Vaccine R&D, NanoBio

CS-UD_Icon8:00 A Replication Defective Human Cytomegalovirus (CMV) Vaccine

Tong-Ming Fu, Ph.D., Senior Investigator, Merck

Congenital CMV infection is one of the leading causes of birth defects; developing a prophylactic vaccine is an unmet medical need. We constructed a replication defective CMV using genetic/chemical switch, by which the functions of two viral proteins essential for viral replication can be regulated by a synthetic molecule. Vaccine virus cannot replicate without the chemical but can induce neutralizing Abs and CD4/8 T cell responses in rhesus monkeys. The vaccine is under Phase I evaluation.

8:30 Preventing RSV Disease in Young Infants

Deborah_Higgins Deborah Higgins, Ph.D., Scientific Director, RSV Vaccine Project, PATH

An overview of RSV vaccine development focused on protecting the youngest infants from severe disease.

9:00 Elimination of the Cold-Chain Dependence of a Nanoemulsion Adjuvanted Vaccine against Tuberculosis by Lyophilization

Ryan M. Kramer, Ph.D., Scientist II, Characterization and Product Development Manager, Infectious Disease Research Institute

Next-generation rationally-designed vaccine adjuvants represent a significant breakthrough to enable development of vaccines against challenging diseases. New vaccine candidates often require maintenance of a cold-chain process to ensure long-term stability and separate vials to enable bedside mixing of antigen and adjuvant. This presents a significant barrier to worldwide implementation of such vaccines. Herein we describe the development and characterization of a tuberculosis vaccine comprised of both antigen and adjuvant components that are stable in a single vial at sustained elevated temperatures.

9:30 NKT Cell Adjuvanted Glycolipid-Peptide Vaccines

Gavin Painter, Ph.D., Science Team Leader, The Ferrier Research Institute, Victoria Institute of Wellington

9:45 PANEL DISCUSSION: What is the Future of Vaccine Adjuvant Development?

This panel discussion will address the following topics: progress in developing next-generation adjuvants, issues in addressing unmet vaccine needs, and effective adjuvants for vaccines against viruses and tumor cells.

Moderator: Jung Huang, Ph.D., Professor, Biochemistry and Molecular Biology, Saint Louis University School of Medicine


Roger H. Brookes, Ph.D., Bioprocess R&D, Sanofi Pasteur

Arnaud Didierlaurent, Ph.D., Director, Translational Research & Adjuvant, GlaxoSmithKline Vaccines

Vidyashankara Iyer, Ph.D., Scientist, Formulation Sciences, MedImmune

Lakshmi Krishnan, Ph.D., Team Leader, Human Health Therapeutics, National Research Council, Canada

10:30 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing

Polly-Matzinger11:15 PLENARY KEYNOTE Dangerous Thoughts on Immunotherapy

Polly C. Matzinger, Ph.D. Senior Investigator, Ghost Lab, Laboratory of Immunogenetics, NAID/NIH

What we think influences what we do. If we continue to view the immune system through the old fashioned self-non-self model, the likelihood of finding truly effective immunotherapies is vanishingly small, whether those therapies are for autoimmunity, cancer or transplantation. I will delineate the different predictions from the various models of immunity and show how they influence how we approach immunotherapy.

12:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:45 Close of Novel Vaccines Part I: Adjuvants

Day 1 | Day 2 | Download Brochure | Speaker Biographies

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