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.
- Vitetta, E.S., et al., A pilot clinical trial of a recombinant ricin vaccine in normal humans. Proc Natl Acad Sci U S A, 2006. 103(7): p. 2268-73.
- 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.
- Thomas, J.C., et al., Effect of single-point mutations on the stability and immunogenicity of a recombinant ricin A chain subunit vaccine antigen. Hum Vaccin Immunother, 2013. 9(4).
- 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.
- Compton, J.R., et al., Introduction of a disulfide bond leads to stabilization and crystallization of a ricin immunogen. Proteins, 2011. 79(4): p. 1048-60.
- 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.
- Neal, L.M., et al., A monoclonal immunoglobulin G antibody directed against an immunodominant linear epitope on the ricin A chain confers systemic and mucosal immunity to ricin. Infect Immun, 2010. 78(1): p. 552-61.
- 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.
- Roche, J.K., et al., Post-exposure targeting of specific epitopes on ricin toxin abrogates toxin- induced hypoglycemia, hepatic injury, and lethality in a mouse model. Lab Invest, 2008. 88(11): p. 1178-91.
- 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.
- Audi, J., et al., Ricin poisoning: a comprehensive review. JAMA, 2005. 294(18): p. 2342-51.
- 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.
- Castelletti, D., et al., A dominant linear B-cell epitope of ricin A-chain is the target of a neutralizing antibody response in Hodgkin's lymphoma patients treated with an anti-CD25 immunotoxin. Clin Exp Immunol, 2004. 136(2): p. 365-72.
- Maddaloni, M., et al., Immunological characteristics associated with the protective efficacy of antibodies to ricin. J. Immunol., 2004. 172(10): p. 6221-8.
- Bradberry, S.M., et al., Ricin poisoning. Toxicol Rev, 2003. 22(1): p. 65-70.
- 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.
- Hunter, R.L., Overview of vaccine adjuvants: present and future. Vaccine, 2002. 20 Suppl 3: p. S7-12.
- Tommasi, M., et al., Identification of ricin A-chain HLA class II-restricted epitopes by human T- cell clones. Clin Exp Immunol, 2001. 125(3): p. 391-400.
- Lindstrom, A.L. and C.A. Pennell, In vitro studies of ricin A-chain-induced vascular leak syndrome. Methods Mol Biol, 2001. 166: p. 125-35.
- Vogelbruch, M., et al., Aluminium-induced granulomas after inaccurate intradermal hyposensitization injections of aluminium-adsorbed depot preparations. Allergy, 2000. 55(9): p. 883-887.
- Furukawa-Stoffer, T.L., et al., A novel biological-based assay for the screening of neutralizing antibodies to ricin. Hybridoma, 1999. 18(6): p. 505-11.
- Baluna, R., et al., Evidence for a structural motif in toxins and interleukin-2 that may be responsible for binding to endothelial cells and initiating vascular leak syndrome. Proc Natl Acad Sci U S A, 1999. 96(7): p. 3957-62.
- Olson, M.A., Ricin A-chain structural determinant for binding substrate analogues: a molecular dynamics simulation analysis. Proteins, 1997. 27(1): p. 80-95.
- Brown, R.F. and D.E. White, Ultrastructure of rat lung following inhalation of ricin aerosol. Int J Exp Pathol, 1997. 78(4): p. 267-76.
- Hewetson JF, A.A., Teters DR, Kotes JM, Washington E, Tamariello R, et al., Immune response and protection of rats and mice from ricin aerosol exposure after vaccination with deglycosylated ricin A chain (Abstract). Fundam Appl Toxicol, 1996. 30(Suppl.): p. 59.
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- Lemley, P.V., P. Amanatides, and D.C. Wright, Identification and characterization of a monoclonal antibody that neutralizes ricin toxicity in vitro and in vivo. Hybridoma, 1994. 13(5): p. 417-21.
- Soler-Rodriguez, A.M., et al., Ricin A-chain and ricin A-chain immunotoxins rapidly damage human endothelial cells: implications for vascular leak syndrome. Exp Cell Res, 1993. 206(2): p. 227-34.
- Hewetson, J.F., et al., Protection of mice from inhaled ricin by vaccination with ricin or by passive treatment with heterologous antibody. Vaccine, 1993. 11(7): p. 743-6.
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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.