Public Health Solutions
Reference literature for our Public Health Solutions pipeline programs.
CiVax™
- COVID-19: Lai, C.Y., To, A., Wong, T.A.S., Lieberman, M.M., Clements, D.E., Senda, J.T., Ball, A.H., Pessaint, L., Andersen, H., Donini, O., Lehrer, A.T. Recombinant protein subunit SARS-CoV-2 vaccines formulated with CoVaccine HT adjuvant induce broad, Th1 biased, humoral and cellular immune responses in mice. 2021.
- COVID-19: Haun, B.K., Lai, C.Y., Williams, C.A., Wong, T.A.S., Lieberman, M.M., Pessaint, L., Andersen, H., Lehrer, A.T. CoVaccine HT™ Adjuvant Potentiates Robust Immune Responses to Recombinant SARS-CoV-2 Spike S1 Immunization. 2020.
Paper
RiVax®
- Westfall J, Yates JL, Van Slyke G, Ehrbar D, Measey T, Straube R, Donini O, Mantis NJ, Thermal stability and epitope integrity of a lyophilized ricin toxin subunit vaccine. Vaccine. 36(40):5967-5976
- Roy, C.J., Brey, R.N., Mantis, N.J., Mapes K., Pop, I.V., Pop, L.M., Ruback, S., Zilleen, S.Z., Doyle-Meyers, L., Vinet-Oliphant, H.S., Didier, P.J., Vitetta,, E.S. Thermostable ricin vaccine protests rhesus macaques against aerosolized ricin: Epitope-specific neutralizing antibodies correlate with protection. PNAS, 2015. 112(12): 3782-87.
- Vance, D.J., Rong, Y., Brey, R.N., Mantis, N.J. Combination of two candidate subunit vaccine antigens elicits protective immunity to ricin and anthrax toxin in mice. Vaccine, 2015. 33(3): 417- 21.
- Vitetta, E.S., J.E. Smallshaw, and J. Schindler, A Small Phase IB Clinical Trial of an Alhydrogel- Adsorbed Recombinant Ricin Vaccine (RiVax). Clin Vaccine Immunol, 2012.
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- Yates JL, Leadbetter E, Mantis NJ. Alpha-galactosylceramide (αGalCer) enhances vaccine-induced protection in a model of ricin intoxication. Hum Vaccin Immunother. 14(8):2053-2057
- Verma, A., et al., Use of site-directed mutagenesis to model the effects of spontaneous deamidation on the immunogenicity of Bacillus anthracis protective antigen. Infect Immun, 2013. 81(1): p. 278-84.
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- Reisler, R.B. and L.A. Smith, The need for continued development of ricin countermeasures. Adv Prev Med, 2012. 2012: p. 149737.
- Remot, A., et al., Nucleoprotein nanostructures combined with adjuvants adapted to the neonatal immune context: a candidate mucosal RSV vaccine. PLoS One, 2012. 7(5): p. e37722.
- O'Hara, J.M., A. Yermakova, and N.J. Mantis, Immunity to ricin: fundamental insights into toxin- antibody interactions. Curr Top Microbiol Immunol, 2012. 357: p. 209-41.
- Mastri, M., et al., Activation of Toll-like receptor 3 (TLR3) amplifies mesenchymal stem cell trophic factors and enhances therapeutic potency. Am J Physiol Cell Physiol, 2012.
- Legler, P.M., et al., Structure of RiVax: a recombinant ricin vaccine. Acta Crystallogr D Biol Crystallogr, 2011. 67(Pt 9): p. 826-30.
- Smallshaw, J.E. and E.S. Vitetta, Ricin Vaccine Development. Curr Top Microbiol Immunol, 2012. 357: p. 259-72.
- Yermakova, A. and N.J. Mantis, Protective immunity to ricin toxin conferred by antibodies against the toxin's binding subunit (RTB). Vaccine, 2011. 29(45): p. 7925-35.
- Porter, A., et al., Evaluation of a ricin vaccine candidate (RVEc) for human toxicity using an in vitro vascular leak assay. Toxicon, 2011. 58(1): p. 68-75.
- McLain, D.E., et al., Protective Effect of Two Recombinant Ricin Subunit Vaccines in the New Zealand White Rabbit Subjected to a Lethal Aerosolized Ricin Challenge: Survival, Immunological Response and Histopathological Findings. Toxicol Sci, 2011.
- Meagher, M.M., et al., Process development and cGMP manufacturing of a recombinant ricin vaccine: An effective and stable recombinant ricin a-chain vaccine-RVEc. Biotechnol Prog, 2011.
- McLain, D.E., et al., Progress in Biological Threat Agent Vaccine Development: A Repeat-Dose Toxicity Study of a Recombinant Ricin Toxin A-Chain (rRTA) 1-33/44-198 Vaccine (RVEc) in Male and Female New Zealand White Rabbits. Int J Toxicol, 2011.
- Mathias-Santos, C., et al., Distinctive immunomodulatory and inflammatory properties of the Escherichia coli type II heat-labile enterotoxin LT-IIa and its B pentamer following intradermal administration. Clin Vaccine Immunol, 2011. 18(8): p. 1243-51.
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- Romani, N., et al., Targeting of antigens to skin dendritic cells: possibilities to enhance vaccine efficacy. Immunol Cell Biol, 2010. 88(4): p. 424-30.
- Ramasamy, S., et al., Principles of antidote pharmacology: an update on prophylaxis, post- exposure treatment recommendations and research initiatives for biological agents. Br J Pharmacol, 2010. 161(4): p. 721-48.
- O'Hara, J.M., et al., Folding domains within the ricin toxin A subunit as targets of protective antibodies. Vaccine, 2010. 28(43): p. 7035-46.
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- Flacher, V., et al., Epidermal Langerhans cells rapidly capture and present antigens from C-type lectin-targeting antibodies deposited in the dermis. J Invest Dermatol, 2010. 130(3): p. 755-62.
- Smallshaw, J.E. and E.S. Vitetta, A lyophilized formulation of RiVax, a recombinant ricin subunit vaccine, retains immunogenicity. Vaccine, 2010. 28(12): p. 2428-35.
- Reinhardt, R.L., H.E. Liang, and R.M. Locksley, Cytokine-secreting follicular T cells shape the antibody repertoire. Nat Immunol, 2009. 10(4): p. 385-93.
- Radosavljevic, V. and G. Belojevic, A new model of bioterrorism risk assessment. Biosecur Bioterror, 2009. 7(4): p. 443-51.
- El, S.-C., et al., Progressive circumscribed sclerosis--a novel side-effect of immunotherapy with aluminium-adsorbed allergen extracts. Allergy, 2009. 64(6): p. 965-7.
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- Dormitzer, P.R., J.B. Ulmer, and R. Rappuoli, Structure-based antigen design: a strategy for next generation vaccines. Trends Biotechnol, 2008. 26(12): p. 659-67.
- Brey, R.N. and N.J. Mantis, Ricin: A type II ribosome inactivating protein, in Vaccines for Biodefense and Neglected Diseases, A. Barrett, Editor. 2008, Elsevier. p. 1100-1115.
- Smallshaw, J.E., J.A. Richardson, and E.S. Vitetta, RiVax, a recombinant ricin subunit vaccine, protects mice against ricin delivered by gavage or aerosol. Vaccine, 2007. 25(42): p. 7459-69.
- Wang, Y., et al., Novel chimeric anti-ricin antibody C4C13 with neutralizing activity against ricin toxicity. Biotechnol Lett, 2007. 29(12): p. 1811-6.
- Peek, L.J., R.N. Brey, and C.R. Middaugh, A rapid, three-step process for the preformulation of a recombinant ricin toxin A-chain vaccine. J Pharm Sci, 2007. 96(1): p. 44-60.
- Smallshaw, J.E., et al., Preclinical toxicity and efficacy testing of RiVax, a recombinant protein vaccine against ricin. Vaccine, 2005. 23(39): p. 4775-84.
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- Olson, M.A., et al., Finding a new vaccine in the ricin protein fold. Protein Eng Des Sel, 2004. 17(4): p. 391-7.
- Olsnes, S., The history of ricin, abrin and related toxins. Toxicon, 2004. 44(4): p. 361-70.
- McHugh, C.A., et al., Improved stability of a protein vaccine through elimination of a partially unfolded state. Protein Sci, 2004. 13(10): p. 2736-43.
- Jefferson, T., M. Rudin, and C. Di Pietrantonj, Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence. Lancet Infect Dis, 2004. 4(2): p. 84-90.
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- Bozzette, S.A., et al., A model for a smallpox-vaccination policy. N Engl J Med, 2003. 348(5): p. 416-25.
- Smallshaw, J.E., et al., Genetic engineering of an immunotoxin to eliminate pulmonary vascular leak in mice. Nat Biotechnol, 2003. 21(4): p. 387-91.
- Smallshaw, J.E., et al., A novel recombinant vaccine which protects mice against ricin intoxication. Vaccine, 2002. 20(27-28): p. 3422-7.
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Paper
- Westfall J, Yates J, Van Slyke G, Measey T, Mantis N, Donini O. Using Monoclonal Antibodies as Immune Correlates of Protection: Thermostable Ricin Toxin Vaccine Development. Poster Presented at Chemical and Biological Defense Science and Technology Conference.
- Donini O, Haulenbeek A, Arumugham R, Schaber C. Orphan Disease, Biodefense and the Animal Rule: A Thermostabilized Ricin Toxin Vaccine. Poster Presentated at the National Organization for Rare Diseases (NORD) Rare Diseases and Orphan Products Breakthrough Summit.
- Roy, C.J., Mantis, N., Brey, R., Vitetta, E., Donini, O. Thermostable Subunit Vaccine Results in Protective Immunity in Rhesus Macaques in an Inhalational Ricin Model. Poster presentation at the 2015 Chemical Biological Defense Science and Technology conference. May 12-14, 2015.
- Leffel, E., Roy, C.J., Brey, R.N., Donini, O. Thermostable Subunit Vaccine Results in Protective Immunity in Rhesus Macaques in an Inhalational Ricin Model. Poster Presentation at 2015 ASM Biodefense and Emerging Diseases Research Meeting. February 9-11, 2015.
Poster
ThermoVax®
- Ebola: Chisholm F, Kang JT, Dong M, Lewis K, Namekar M, Lehrer AT, Randolph TW. Thermostable Ebola Virus Vaccine Formulations Lyophilized in the Presence of Aluminum Hydroxide. Eur. J. Pharm. Bipharm. 2019. 136: 213-20.
- Anthrax: Hassett K.J., Vance D.J., Jain, N.K., Sahni, N., Rabia, L.A., Cousins, M.C., Joshi, S. Volkin, D.B., Middaugh, C.R., Mantis, N.J., Carpenter, J.F., Randolph, T.W. Glassy-state stabilization of a dominant negative inhibitor anthrax vaccine containing aluminum hydroxide and glycopyranoside lipid adjuvants. J. Pharm. Sci 2015. 104(2): 627-39.
- HPV: Hassett, K.J., Meinerz N.M., Semmelmann F., Cousins M.C., Garcea, R.L, Randolph, T.W. Development of a highly thermostable, adjuvanted human papillomavirus vaccine. Eur. J. Pharm. Biopharm. 2015.
- Albert To, Teri Ann S. Wong, Aquena H. Ball, Michael M. Lieberman, Jake Yalley-Ogunro, Mehtap Cabus, Sara Nezami, Fabian Paz, Hanne Andersen Elyard, Viktoriya Borisevich, Krystle N. Agans, Daniel J. Deer, Courtney Woolsey, Robert W. Cross, Thomas W. Geisbert, Oreola Donini, Axel T. Lehrer, Thermostable bivalent filovirus vaccine protects against severe and lethal Sudan ebolavirus and marburgvirus infection, Vaccine, 2023, ISSN 0264-410X.
- Ricin+Anthrax: Vance, D.J., Rong, Y., Brey, R.N., Mantis, N.J. Combination of two candidate subunit vaccine antigens elicits protective immunity to ricin and anthrax toxin in mice. Vaccine 2015. 33(3): 417-21.
- Ricin: Roy, C.J., Brey, R.N., Mantis, N.J., Mapes K., Pop, I.V., Pop, L.M., Ruback, S., Zilleen, S.Z., Doyle-Meyers, L., Vinet-Oliphant, H.S., Didier, P.J., Vitetta,, E.S. Thermostable ricin vaccine protests rhesus macaques against aerosolized ricin: Epitope-specific neutralizing antibodies correlate with protection. PNAS 2015. 112(12): 3782-87.
Paper
- Preston, K.B., Monticello, C.R., Wong, T.A., Donini, O., Lehrer, A.T., Randolph, T.W. Preservation of Quaternary Structure in Thermostable, Lyophilized Ebola Glycoprotein Vaccines. Poster presentation at the 2019 Colorado Protein Stability Conference. July 30-August 1, 2019.
- Preston, K.B., Monticello, C.R., Wong, T.A., Donini, O., Lehrer, A.T., Randolph, T.W. Preliminary Stability Assays for a Thermostable, Trivalent Filovirus Vaccine. Poster presentation at the 2019 Colorado Protein Stability Conference. July 30-August 1, 2019.
- Chisholm, C.F., Kang, T.K., Lehrer, A., Donini, O.,, Randolph, T.W. Thermostable Lyophilized Ebola Vaccine Formulations. Poster presentation at the 2016 Workshop on Protein Aggregation and Immunogenicity. August 2-4, 2016.
- Roy, C.J., Mantis, N., Brey, R., Vitetta, E., Donini, O. Thermostable Subunit Vaccine Results in Protective Immunity in Rhesus Macaques in an Inhalational Ricin Model. Poster presentation at the 2015 Chemical Biological Defense Science and Technology conference.
- Donini, O., Hassett, K., Vance, D., Rabia, L., Cousins, M., Middaugh, R., Carpenter, J., Mantis, N., and Randolph, T. Stability, Efficacy and Immunogenicity of a Third Generation Heat-Stable Anthrax Subunit Vaccine. Poster presentation at the 2015 Chemical Biological Defense Science and Technology conference. May 12-14, 2015.
- Leffel, E., Roy, C.J., Brey, R.N., Donini, O. Thermostable Subunit Vaccine Results in Protective Immunity in Rhesus Macaques in an Inhalational Ricin Model. Poster Presentation at 2015 ASM Biodefense and Emerging Diseases Research Meeting. February 9-11, 2015.
Poster
SGX943
- Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Elder J, Sonis S, Straube S, Donini O. Dusquetide: A novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study. J Biotech 2016; 239: 115-125.
- North JR, Takenaka S, Rozek A, Kielczewska A, Opal S, Morici L, Finlay BB, Schaber CJ, Straube R, Donini O. A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy. J Biotech 2016; 226: 24-34.
- Scott MG, Dullaghan E, Mookherjee N, Glavas N, Waldbrook M, Thompson A, Wang A, Lee K, Doria S, Hamill P, Yu JJ, Li Y, Donini O, Guarna MM, Finlay BF, North JR, Hancock REW. An anti-infective peptide that selectively modulates the innate immune response. Nat Biotechnol 2007;25: 465-72.
- Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Scott Z, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: Reduction in oral mucositis associated with enduring ancillary benefits in tumor resolution and decreased mortality in head and neck cancer patients. Biotech Reports. 2017; 15:24-26.
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Paper
- Donini O, Straube R. Host-Directed Innate Defense Regulators with Preclinical and Clinical Proof of Concept. Poster presentated at the 2018 American Society of Microbiology Microbe Conference. 2018.
- Donini O, Straube R. Host-Directed Innate Defense Regulators (IDRs) – Agnostic Therapy to Treat Bacterial Infections and Fight Resistance. Poster presentated at the 2018 ESCMID/ASM Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. 2018.
- Donini O, Behrens E, Haulenbeek A, Pullion C, Schaber C. An Innate Defense Regulator for the Treatment of Macrophage Activation Syndrome: Preclinical Studies in an Orphan Indication. Poster Presentated at the National Organization for Rare Diseases (NORD) Rare Diseases and Orphan Products Breakthrough Summit. 2016.
- Donini O, Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Elder J. SGX942 Reduces the Duration of Severe Oral Mucositis. Poster presented at the 25th Multinational Association of Supportive Care in Cancer. 2016.
- Kielczewska A, Yu HB, Rozek A, Takenaka S, Li Y, Guarna MM, North JR, Foster LJ, Finlay BB, Donini O. Sequestosome-1 / p62 is the key intracellular target of innate defense regulator peptide. Poster presentation at Keystone Symposium on The Macrophage: The intersection of Pathogenic & Protective Inflammation. 2010.
- Donini O, Watkins BA, Palardy J, Opal S, Sonis S, Abrams MJ, North JR. Reduced Infection and Mucositis in Chemotherapy-Treated Animals Following Innate Defense Modulation Using a Novel Drug Candidate. 2010. Blood (ASH Annual Meeting Abstracts) 2010; 116:3781.
- Takenaka S, Rozek A, Kielczewska A, Thorson L, North JR, Finlay BB, Donini O. Innate Defense Regulators are a novel macrophage-mediated therapy to treat infectious and inflammatory diseases. Poster presentation at Keystone Symposium on The Macrophage: The intersection of Pathogenic & Protective Inflammation. 2010.
- Yu H, Kielczewska A, Rozek A, Takenaka S, Li Y, Guarna M, Thorson L, Hancock R, North J, Foster L, Donini O, Finlay B. SQSTM-1/p62: A Novel Therapeutic Target in Infectious and Inflammatory Disease. Poster Presentation at 49th Interscience Conference on Antimicrobial Agents and Chemotherapy. 2009.