Publications & Presentations

Our scientific and clinical findings have been presented and published in prestigious peer-reviewed forums, and a selection of these have been curated for reference.

Latest Publications

Date Program Title of Publication
JUN 2018 Heplisav

HEPLISAV-B®, 2-Dose Hepatitis B Vaccine Using a Toll-like Receptor 9 Adjuvant, is Well Tolerated and Induces Higher Rates of Seroprotection than Engerix-B in Persons with Diabetes Aged 60 Years or Older

American Diabetes Assoc.
Randall N Hyer, MD, PhD, MPH; Robert S Janssen, MD

MAY 2018 Heplisav

Safety of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant in adults

Vaccine. 2018 May 3;36(19):2604-2611
Hyer R, McGuire DK, Xing B, Jackson S, Janssen R.

Heplisav

Date Program Title of Publication
JUN 2018 Heplisav

HEPLISAV-B®, 2-Dose Hepatitis B Vaccine Using a Toll-like Receptor 9 Adjuvant, is Well Tolerated and Induces Higher Rates of Seroprotection than Engerix-B in Persons with Diabetes Aged 60 Years or Older

American Diabetes Assoc.
Randall N Hyer, MD, PhD, MPH; Robert S Janssen, MD

MAY 2018 Heplisav

Safety of a two-dose investigational hepatitis B vaccine, HBsAg-1018, using a toll-like receptor 9 agonist adjuvant in adults

Vaccine. 2018 May 3;36(19):2604-2611
Hyer R, McGuire DK, Xing B, Jackson S, Janssen R.

OCT 2016 Heplisav

Development of the CpG Adjuvant 1018: A Case Study

Vaccine Adjuvants (Methods Mol Biol.) 2017;1494:15-27
Campbell JD

JUL 2015 Heplisav

Immunogenicity of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in subpopulations of healthy adults 18-70 years of age.

Vaccine. 2015 Jul 17;33(31):3614-8.
Janssen JM, Jackson S, Heyward WL, Janssen RS.

FEB 2015 Heplisav

Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease and type 2 diabetes mellitus.

Vaccine. 2015 Feb 11;33(7):833-7
Janssen JM, Heyward WL, Martin JT, Janssen RS.

NOV 2013 Heplisav

Immunogenicity and safety of an investigational hepatitis B vaccine with a toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease.

Vaccine. 2013 Nov 4;31(46):5306-13.
Janssen RS, Mangoo-Karim R, Pergola PE, Girndt M, Namini H, Rahman S, Bennett SR, Heyward WL, Martin JT.

NOV 2013 Heplisav

Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40–70 years of age.

Vaccine. 2013 Nov 4;31(46):5300-5.
Heyward WL, Kyle M, Blumenau J, Davis M, Reisinger K, Kabongo ML, Bennett S, Janssen RS, Namini H, Martin JT.

MAR 2012 Heplisav

Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18–55 years of age.

Vaccine, 2012; 30(15): 2556-2563.
Scott A. Halperin, Brian Ward, et al.

TLR Biology

Date Program Title of Publication
APR 2016 TLR Biology

Optimization, Production, and Characterization of a CpGOligonucleotide-Ficoll Conjugate Nanoparticle Adjuvant for Enhanced Immunogenicity of Anthrax Protective Antigen

Bioconjugate Chemistry, 2016, 27, 1293−1304, DOI: 10.1021/acs.bioconjchem.6b00107
Bob Milley, Radwan Kiwan, Gary S. Ott, Carlo Calacsan, Melissa Kachura, John D. Campbell, Holger Kanzler, and Robert L. Coffman

DEC 2015 TLR Biology

A CpG-Ficoll Nanoparticle Adjuvant for Anthrax Protective Antigen Enhances Immunogenicity and Provides Single-Immunization Protection against Inhaled Anthrax in Monkeys

The Journal of Immunology, 2016; 196:284-297; Prepublished online 25 November 2015; doi: 10.4049/jimmunol.1501903
Melissa A. Kachura, Colin Hickle et al.

JAN 2014 TLR Biology

Immunostimulatory DNA as a Vaccine Adjuvant.

The Expert Review of Vaccines, 2007; 6(5):747-759.
Debbie Higgins, Jason D Marshal, Paula Traquina, Gary Van Nest and Brian Livingston.

AUG 2012 TLR Biology

Safety and immunogenicity of different two-dose regimens of an investigational hepatitis B vaccine (hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide) in healthy young adults.

Vaccine, 2012; 30(36):5445-5448.
Scott A. Halperin, Shelly McNeil, Joanne M. Langley, Bruce Smith, Donna MacKinnon-Cameron, Robyn McCall-Sani, William L. Heyward, J. Tyler Martin.

MAR 2012 TLR Biology

Demonstration of safety and enhanced seroprotection against hepatitis B with investigational HBsAg-1018 ISS vaccine compared to a licensed hepatitis B vaccine.

Vaccine, 2012; 30(16): 2689-2696.
Benjamin P. Sablan, Dong Joon Kim et al

JUL 2011 TLR Biology

Assessing the safety of adjuvanted vaccines.

Sci. Transl. Med., 2011; 3(93):93rv2.
Ahmed SS, Plotkin SA, Black S, Coffman RL.

MAR 2011 TLR Biology

Netting neutrophils are major inducers of type I IFN production in pediatric systemic lupus erythematosus.

Sci. Transl. Med., 2011; 3(73):73ra20. PMCID: 3143837.
Garcia-Romo GS, Caielli S et al.

FEB 2011 TLR Biology

Selective utilization of Toll-like receptor and MyD88 signaling in B cells for enhancement of the antiviral germinal center response.

Immunity, 2011; 34(3):375-384.
Hou B, Saudan P, Ott G, Wheeler ML, Ji M, Kuzmich L, Lee LM, Coffman RL, Bachmann MF, DeFranco AL.

DEC 2010 TLR Biology

Autoimmune skin inflammation is dependent on plasmacytoid dendritic cell activation by nucleic acids via TLR7 and TLR9.

J. Exp. Med., 2010; 207(13):2931-42.
Guiducci C, Tripodo C, Gong M, Sangaletti S, Colombo MP, Coffman RL, Barrat FJ.

OCT 2010 TLR Biology

Vaccine adjuvants: putting innate immunity to work.

Immunity, 2010; 33(4):492-503.
Coffman, RL, Sher A, Seder RA.

JUN 2010 TLR Biology

TLR recognition of self nucleic acids hampers glucocorticoid activity in lupus.

Nature, 2010; 465(7300):937-41.
Guiducci C, Gong M et al.

FEB 2010 TLR Biology

Ro60-associated single-stranded RNA links inflammation with fetal cardiac fibrosis via ligation of TLRs: a novel pathway to autoimmune-associated heart block.

J. Immunol., 2010; 184(4):2148-55.
Clancy RM, Alvarez D, Komissarova E, Barrat FJ, Swartz J, Buyon JP.

AUG 2009 TLR Biology

CpG-containing immunostimulatory DNA sequences elicit TNF-α–dependent toxicity in rodents but not in humans.

J. Clin. Invest., 2009; 119(9):2564–2576.
John D. Campbell, Yan Cho, et al.

AUG 2009 TLR Biology

Self-RNA-antimicrobial peptide complexes activate human dendritic cells through TLR7 and TLR8.

J. Exp. Med., 2009; 206(9):1983-94.
D. Ganguly, G. Chamilos, R. Lande, J. Gregorio, S. Meller, V. Facchinetti, B. Homey, F.J. Barrat, T. Zal, and M. Gilliet.

JAN 2009 TLR Biology

Signalling pathways leading to IFN-a production in human PDC and the possible use of agonists or antagonists of TLR-7 and TLR-9 in clinical indications (Review).

J. Intern. Med., 2009; 265:43-57.
Guiducci C, Coffman RL, Barrat FJ (Dynavax Technologies Corporation, Berkeley, CA USA).

2009 TLR Biology

Biomarkers measuring the activity of Toll-like receptor ligands in clinical development programs.

Toll-Like Receptors (Methods Mol Bio) 2009;517:415-40
Sims P, Coffman RL, Hessel EM.

NOV 2008 TLR Biology

Pathogenic anti-DNA antibodies modulate gene expression in mesangial cells: Involvement of HMGB1 in anti-DNA antibody-induced renal injury.

Immunology Letters, 2008; 121:61–73.
Xiaoping Qing, Milena Pitashny, David B. Thomas, Franck J. Barrat, Mark P. Hogarth, Chaim Putterman.

JUL 2008 TLR Biology

Development of TLR inhibitors for the treatment of autoimmune diseases.

Immunological Reviews, 2008; 223:271-283.
Frank J. Barrat and Robert L. Coffman.

MAR 2008 TLR Biology

PI3K is critical for the nuclear translocation of IRF-7 and type I IFN production by human plasmacytoid predendritic cells in response to TLR activation

.J. Exp. Med., 2008; 205(2):315-22
Cristiana Guiducci, Cristina Ghirelli et al.

DEC 2007 TLR Biology

Treatment of lupus-prone mice with a dual inhibitor of TLR7 and TLR9 leads to reduction of autoantibody production and amelioration of disease symptoms.

Eur. J. Immunol., 2007; 37(12):3582-6.
Franck J. Barrat, Thea Meeker, Jean H. Chan, Cristiana Guiducci and Robert L. Coffman.

OCT 2007 TLR Biology

Interferon-{alpha} promotes abnormal vasculogenesis in lupus: a potential pathway for premature atherosclerosis.

Blood, 2007; 110:2907-2915.
Denny M.F., Thacker S., Mehta H., Somers E.C., Dodick T., Barrat F.J., McCune W.J. and Kaplan M.J.

JUN 2007 TLR Biology

Negative regulation of TLR9-mediated IFN-{alpha} induction by a small-molecule, synthetic TLR7 ligand.

Journal of Leukocyte Biology, 2007; 82(3):497-508.
Marshall JD, Heeke DS, Gesner ML, Livingston B, Van Nest G.

MAY 2007 TLR Biology

Therapeutic targeting of innate immunity with Toll-like receptor agonists and antagonists.

Nature Medicine, 2007; 13(5):552-559.
Holger Kanzler, Franck J Barrat, Edith M Hessel & Robert L Coffman.

NOV 2006 TLR Biology

Evolving strategies for the prevention of influenza infection: potential for multistrain targeting.

BioDrugs, 2006; 6(20):335-340(6).
Livingston BD, Higgins D, Van Nest G.

OCT 2006 TLR Biology

TLR9-Based Immunotherapy for Allergic Disease.

The American Journal of Medicine, 2006; 119(10):897.e1-6
Tomoko Hayashi, MD, PhD, Eyal Raz, MD.

SEP 2006 TLR Biology

Toll-like Receptor Recognition Regulates Immunodominance in an Antimicrobial CD4+ T Cell Response.

Immunity, 2006; 25:665-664.
Felix Yarovinsky, Holger Kanzler, Sara Hieny, Robert L. Coffman, and Alan Sher.

AUG 2006 TLR Biology

Properties Regulating the Nature of the Plasmacytoid Dendritic Cell Response to TLR9 Activation.

J. Exp. Med., 2006; 203(8):1999-2008.
Cristiana Guiducci, Gary Ott, Jean H. Chan, Emily Damon, Carlo Calacsan, Tracy Matray, Kyung-Dall Lee, Robert L. Coffman and Franck J. Barrat.

JUN 2006 TLR Biology

Origins of the Th1-Th2 model: a personal perspective.

Nat. Immunol., 2006; 7(6):539-41.
Robert L. Coffman.

JAN 2006 TLR Biology

Comparison of the safety and immunogenicity of hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide and a licensed hepatitis B vaccine in healthy young adults.

Vaccine, 2006; 24(1): 20-26.
Scott A. Halperin, Simon Dobson et al.

NOV 2005 TLR Biology

Human TLR-7-, -8-, and -9-Mediated Induction of IFN-alpha/beta and -lambda is IRAK-4 Dependent and Redundant for Protective Immunity to Viruses.

Immunity, 2005; 23:465-478.
Kun Yang, Anne Puel, et al.

OCT 2005 TLR Biology

Nucelic acids of mammalian origin can act as endogenous ligands for Toll-like receptors and may promote systemic lupus erythematosus.

J. Exp. Med., 2005; 202(8):1131-1139.
Franck J. Barrat, Thea Meeker, Josh Gregorio, Jean H. Chan, Satoshi Uematsu, Shizuo Akira, Bonnie Chang, Omar Duramad, and Robert L. Coffman.

FEB 2005 TLR Biology

Superior Activity of the Type C Class of ISS In Vitro and In Vivo Across Multiple Species.

DNA Cell Biol., 2005; 24(2):63-72.
Marshall, J.D., K.L. Fearon, et al.

FEB 2005 TLR Biology

Inhibitors of TLR-9 Act on Multiple Cell Subsets in Mouse and Man In Vitro and Prevent Death In Vivo from Systemic Inflammation.

J. Immunol., 2005; 174:5193–5200.
Omar Duramad, Karen L. Fearon, Bonnie Chang, Jean H. Chan, Josh Gregorio, Robert L. Coffman, and Franck J. Barrat.

AUG 2004 TLR Biology

CpG-C immunostimulatory oligodeoxyribonucleotide activation of plasmacytoid dendritic cells in rhesus macaques to augment the activation of IFN-gamma-secreting simian immunodeficiency virus-specific T cells.

J. Immunol., 2004; 173(3):1647-1657.
Teleshova, N., J. Kenney, J. Jones, J. Marshall, G. Van Nest, J. Dufour, R. Bohm, J.D. Lifson, A. Gettie, and M. Pope.

JUN 2004 TLR Biology

Polymyxin B enhances ISS-mediated immune responses across multiple species.

Cell. Immunol., 2004; 229(2):93-105.
Marshall, J.D., D. Higgins, C. Abbate, P. Yee, G. Teshima, G. Ott, T. Dela Cruz, D. Passmore, K.L. Fearon, S. Tuck, and G. Van Nest.

JUN 2004 TLR Biology

Selective immune redirection in humans with ragweed allergy by injecting Amb a 1 linked to immunostimulatory DNA.

J. Allergy Clin. Immunol., 2004; 113(6):1144-1151.
Simons, F.E., Y. Shikishima, G. Van Nest, J.J. Eiden, and K.T. HayGlass.

DEC 2003 TLR Biology

IL-10 regulates plasmacytoid dendritic cell response to CpG-containing immunostimulatory sequences.

Blood, 2003; 102(13):4487-4492.
Duramad, O., K.L. Fearon, J.H. Chan, H. Kanzler, J.D. Marshall, R.L. Coffman, and F.J. Barrat.

AUG 2003 TLR Biology

A minimal human immunostimulatory CpG motif that potently induces IFN-gamma and IFN-alpha production.

Eur. J. Immunol., 2003; 33: 2114-2122.
Fearon, K., J.D. Marshall, C. Abbate, S. Subramanian, P. Yee, J. Gregorio, G. Teshima, G. Ott, S. Tuck, G. Van Nest, and R.L. Coffman.

JUL 2003 TLR Biology

Novel chimeric immunomodulatory compounds containing short CpG oligodeoxyribonucleotides have differential activities in human cells.

Nucl. Acids Res., 2003; 31(17):5122-5133.
Marshall, J.D., E.M. Hessel, J. Gregorio, C. Abbate, P. Yee, M. Chu, G.V. Nest, R.L. Coffman, and K.L. Fearon.

JUN 2003 TLR Biology

A phase I study of the safety and immunogenicity of recombinant hepatitis B surface antigen co-administered with an immunostimulatory phosphorothioate oligonucleotide adjuvant.

Vaccine, 2003; 21(19-20): 2461-2467.
Halperin, S.A., G. Van Nest, B. Smith, S. Abtahi, H. Whiley, and J.J. Eiden.

JUN 2003 TLR Biology

Identification of a novel CpG DNA class and motif that optimally stimulate B cell and plasmacytoid dendritic cell functions.

J. Leukoc. Biol., 2003; 73(6):781-792.
Marshall, J.D., K. Fearon, C. Abbate, S. Subramanian, P. Yee, J. Gregorio, R.L. Coffman, and G. Van Nest.

AUG 2002 TLR Biology

Use of Immunostimulatory Sequence-Containing Oligonucleotides as Topical Therapy for Genital Herpes Simplex Virus Type 2 Infection 

J. Virol., 2002; 76: 11387-11396.
Pyles, R.B., D. Higgins, C. Chalk, A. Zalar, J. Eiden, C. Brown, G. Van Nest, and L.R. Stanberry.

AUG 2001 TLR Biology

Immunostimulatory Sequence DNA Linked to the Amb a 1 Allergen Promotes Th1 Cytokine Expression While Downregulating Th2 Cytokine Expression in PBMCs from Human Patients with Ragweed Allergy.

J. Allergy Clin. Immunol., 2001; 108:191-197.
Marshall, J.D., S. Abtahi et al.

JUL 2000 TLR Biology

Conjugation of Immunostimulatory DNA to the Short Ragweed Allergen Amb a 1 Enhances its Immunogenicity and Reduces its Allergenicity.

J. Allergy Clin. Immunol., 2000; 106:124-134.
Tighe, H., Takabayashi, K. et al.

NOV 1998 TLR Biology

Immunostimulatory DNA Is a Potent Mucosal Adjuvant.

Cell. Immunol., 1998; 190: 77-82.
Horner, A.A., A. Ronaghy, P.M. Cheng, M.D. Nguyen, H.J. Cho, D. Broide, and E. Raz.

AUG 1997 TLR Biology

Immunostimulatory DNA Sequences Function as T helper-1-promoting Adjuvants.

Nature Medicine, 1997; 3: 849-854.
Roman, M., E. Martin-Orozco, J.S. Goodman, M.D. Nguyen, Y. Sato, A. Ronaghy, R.S. Kornbluth, D.D. Richman, D.A. Carson, and E. Raz.

JUL 1996 TLR Biology

Immunostimulatory DNA Sequences Necessary for Effective Intradermal Gene Immunization.

Science, 1996; 273: 352-354.
Sato, Y., M. Roman, H. Tighe, D. Lee, M. Corr, M.D. Nguyen, G.J. Silverman, M. Lotz, D.A. Carson, and E. Raz.