Vaccine Development

We have demonstrated expertise in vaccine development, especially utilizing Psoralen inactivation techniques for bacterial and viral pathogens. This includes culturing bacterial pathogens, inactivation and generation of pilot vaccine stock, animal work, and associated development and utilization of diagnostics for immunogenicity assays.

Furthermore, we have have an extensive publication record applying these psoralen inactivation techniques along with developing the requite assays as shown by some of our selected publications below:

  1. Westcott MM, Blevins M, Wierzba TF, Morse AE, White KR, Sanders LA, et al. The Immunogenicity and Properties of a Whole-Cell ETEC Vaccine Inactivated with Psoralen and UVA Light in Comparison to Formalin. Microorganisms [Internet]. 2023 Aug 9;11(8):2040. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10458022/

  2. Sundaram AK, Ewing D, Blevins M, Liang Z, Sink S, Lassan J, et al. Comparison of purified psoralen-inactivated and formalin-inactivated dengue vaccines in mice and nonhuman primates. Vaccine. 2020 Apr 9;38(17):3313–20.

  3. Williams M, Ewing D, Blevins M, Sun P, Sundaram AK, Raviprakash KS, et al. Enhanced immunogenicity and protective efficacy of a tetravalent dengue DNA vaccine using electroporation and intradermal delivery. Vaccine [Internet]. 2019 Jul 26;37(32):4444–53. Available from: https://www.sciencedirect.com/science/article/pii/S0264410X19308710

  4. Maves RC, Oré RMC, Porter KR, Kochel TJ. Immunogenicity and protective efficacy of a psoralen-inactivated dengue-1 virus vaccine candidate in Aotus nancymaae monkeys. Vaccine. 2011 Mar 24;29(15):2691–6.

Therapeutics

Providing clinically relevant therapeutics and diagnostics, leveraging our decades of combined clinical experience. Members of BCVT bring a patient-focused approach to developing new therapeutic and diagnostic aids. Pairing state of the art pharmaceutics with new approaches in big data and machine learning, BCVT members have developed online calculators and created novel therapeutic approaches.

Some of our members published work in this area includes:

  1. Stone TJ, DeWitt M, Johnson JW, Beardsley JR, Munawar I, Palavecino E, et al. Analysis of infections among patients with historical culture positive for extended-spectrum beta-lactamase (ESBL)–producing Escherichia coli or Klebsiella pneumoniae: Is ESBL-targeted therapy always needed? Antimicrobial Stewardship & Healthcare Epidemiology [Internet]. 2023 ed [cited 2023 Mar 8];3(1):e47. Available from: https://www.cambridge.org/core/journals/antimicrobial-stewardship-and-healthcare-epidemiology/article/analysis-of-infections-among-patients-with-historical-culture-positive-for-extendedspectrum-betalactamase-esblproducing-escherichia-coli-or-klebsiella-pneumoniae-is-esbltargeted-therapy-always-needed/D7BE9834CAACC791958E6FD27B87289A

  2. McNeil CJ, Williamson JC, Muzny CA. Successful Treatment of Persistent 5-Nitroimidazole-Resistant Trichomoniasis With an Extended Course of Oral Secnidazole Plus Intravaginal Boric Acid. Sex Transm Dis. 2023 Apr 1;50(4):243–6.

  3. Williamson JC, Pegram PS. Neuraminidase inhibitors in patients with underlying airways disease. Am J Respir Med. 2002;1(2):85–90.

  4. Chittick P, Williamson JC, Ohl CA. BK virus encephalitis: case report, review of the literature, and description of a novel treatment modality. Ann Pharmacother. 2013 Sep;47(9):1229–33.

  5. Herring AR, Williamson JC. Principles of antimicrobial use in older adults. Clin Geriatr Med. 2007 Aug;23(3):481–97, v.

  6. Logan A, Wolfe A, Williamson JC. Antifungal Resistance and the Role of New Therapeutic Agents. Curr Infect Dis Rep. 2022;24(9):105–16.

  7. Trotman RL, Williamson JC, Shoemaker DM, Salzer WL. Antibiotic dosing in critically ill adult patients receiving continuous renal replacement therapy. Clin Infect Dis. 2005 Oct 15;41(8):1159–66.

Clinical Trial Support

BCVT has an expansive experience in running Phase 1-3 trials. This includes designing, executing, and supporting Phase 1-2a trials along with randomized, placebo controlled Phase 3 trials across the world.

BCVT brings decades of experience in executing many parts of clinical trials both within the United States of American and internationally. Below represents a small selection of the trials on which members of BCVT have been apart:

  1. Boulware DR, Lindsell CJ, Stewart TG, Hernandez AF, Collins S, McCarthy MW, et al. Inhaled Fluticasone Furoate for Outpatient Treatment of Covid-19. N Engl J Med. 2023 Sep 21;389(12):1085–95.

  2. El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, et al. Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase. N Engl J Med. 2021 Nov 4;385(19):1774–85.

  3. Stewart TG, Rebolledo PA, Mourad A, Lindsell CJ, Boulware DR, McCarthy MW, et al. Higher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19: The ACTIV-6 Randomized Clinical Trial. JAMA. 2023 Dec 26;330(24):2354–63.

  4. Naggie S, Boulware DR, Lindsell CJ, Stewart TG, Gentile N, Collins S, et al. Effect of Ivermectin vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial. JAMA. 2022 Oct 25;328(16):1595–603.

  5. Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403–16.

  6. Hall ER, Wierzba TF, Ahrén C, Rao MR, Bassily S, Francis W, et al. Induction of systemic antifimbria and antitoxin antibody responses in Egyptian children and adults by an oral, killed enterotoxigenic Escherichia coli plus cholera toxin B subunit vaccine. Infect Immun. 2001 May;69(5):2853–7.

  7. Savarino SJ, Brown FM, Hall E, Bassily S, Youssef F, Wierzba T, et al. Safety and immunogenicity of an oral, killed enterotoxigenic Escherichia coli-cholera toxin B subunit vaccine in Egyptian adults. J Infect Dis. 1998 Mar;177(3):796–9.

  8. Ratanasuwan W, Kim YH, Sah BK, Suwanagool S, Kim DR, Anekthananon A, et al. Peru-15 (Choleragarde(®)), a live attenuated oral cholera vaccine, is safe and immunogenic in human immunodeficiency virus (HIV)-seropositive adults in Thailand. Vaccine. 2015 Sep 11;33(38):4820–6.

  9. Qadri F, Wierzba TF, Ali M, Chowdhury F, Khan AI, Saha A, et al. Efficacy of a Single-Dose, Inactivated Oral Cholera Vaccine in Bangladesh. N Engl J Med. 2016 May 5;374(18):1723–32.

  10. Raqib R, Sarker P, Zaman K, Alam NH, Wierzba TF, Maier N, et al. A phase I trial of WRSS1, a Shigella sonnei live oral vaccine in Bangladeshi adults and children. Hum Vaccin Immunother. 2019;15(6):1326–37.

  11. Sarker P, Mily A, Ara A, Haque F, Maier N, Wierzba TF, et al. Functional Antibodies and Innate Immune Responses to WRSS1, a Live Oral Shigella sonnei Vaccine Candidate, in Bangladeshi Adults and Children. J Infect Dis. 2021 Dec 20;224(12 Suppl 2):S829–39.

  12. Qadri F, Ali M, Lynch J, Chowdhury F, Khan AI, Wierzba TF, et al. Efficacy of a single-dose regimen of inactivated whole-cell oral cholera vaccine: results from 2 years of follow-up of a randomised trial. Lancet Infect Dis. 2018 Jun;18(6):666–74.

  13. Qadri F, Akhtar M, Bhuiyan TR, Chowdhury MI, Ahmed T, Rafique TA, et al. Safety and immunogenicity of the oral, inactivated, enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi children and infants: a double-blind, randomised, placebo-controlled phase 1/2 trial. Lancet Infect Dis. 2020 Feb;20(2):208–19.

  14. Desai SN, Akalu Z, Teshome S, Teferi M, Yamuah L, Kim DR, et al. A Randomized, Placebo-Controlled Trial Evaluating Safety and Immunogenicity of the Killed, Bivalent, Whole-Cell Oral Cholera Vaccine in Ethiopia. Am J Trop Med Hyg. 2015 Sep;93(3):527–33.

  15. Akhtar M, Chowdhury MI, Bhuiyan TR, Kaim J, Ahmed T, Rafique TA, et al. Evaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses. Vaccine. 2019 Sep 3;37(37):5645–56.

Preclinical and Basic Research

BCVT has experience in all phases of basic and preclinical research including the development of animal models, diagnostic assays. Leveraging our expansive contacts within academic laboratories, we have access to cutting edge molecular methods including next generation and whole genome sequencing, various “omic” techniques, and other approaches.

We have leveraged these capabilities across the full preclinical pipeline, from establishing and refining animal models of infection to designing and validating the immunogenicity and diagnostic assays needed to evaluate candidate vaccines and therapeutics. Our team combines hands-on laboratory expertise with rigorous study design and applied statistics, ensuring that early-stage findings are robust, reproducible, and translatable to the clinic. By integrating molecular, immunological, and computational approaches, BCVT helps partners de-risk their programs and build the evidence base required to advance promising candidates toward clinical development.