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.