Entolimod, an Adjuvant for Vaccine Augmentation

Summary

The primary objective of this pilot study to evaluate the safety of low dose Entolimod in normal, healthy, non-patient normals. This clinical trial in 40 normal humans compares a single dose of 4 ug Td (2 ug of TT and 2 ug of diphtheria toxoid + 3000 ug of alum with or without entolimod. Subjects will be randomized to: Td alone (n=15) and Td+ entolimod (n=25). The investigators expect that Td + entolimod will double the anti-TT and anti-diphtheria AB levels over Td alone.

Timeline

Start

2017-12-08

Primary completion

2018-03-09

Completion

2019-12-31

Publications

• Background Krivokrysenko VI, Toshkov IA, Gleiberman AS, Krasnov P, Shyshynova I, Bespalov I, Maitra RK, Narizhneva NV, Singh VK, Whitnall MH, Purmal AA, Shakhov AN, Gudkov AV, Feinstein E. The Toll-Like Receptor 5 Agonist Entolimod Mitigates Lethal Acute Radiation Syndrome in Non-Human Primates. PLoS One. 2015 Sep 14;10(9):e0135388. doi: 10.1371/journal.pone.0135388. eCollection 2015.
• Background Krivokrysenko VI, Shakhov AN, Singh VK, Bone F, Kononov Y, Shyshynova I, Cheney A, Maitra RK, Purmal A, Whitnall MH, Gudkov AV, Feinstein E. Identification of granulocyte colony-stimulating factor and interleukin-6 as candidate biomarkers of CBLB502 efficacy as a medical radiation countermeasure. J Pharmacol Exp Ther. 2012 Nov;343(2):497-508. doi: 10.1124/jpet.112.196071. Epub 2012 Jul 26.
• Background Leigh ND, Bian G, Ding X, Liu H, Aygun-Sunar S, Burdelya LG, Gudkov AV, Cao X. A flagellin-derived toll-like receptor 5 agonist stimulates cytotoxic lymphocyte-mediated tumor immunity. PLoS One. 2014 Jan 14;9(1):e85587. doi: 10.1371/journal.pone.0085587. eCollection 2014.
• Background Howell BA, Siler SQ, Shoda LK, Yang Y, Woodhead JL, Watkins PB. A mechanistic model of drug-induced liver injury AIDS the interpretation of elevated liver transaminase levels in a phase I clinical trial. CPT Pharmacometrics Syst Pharmacol. 2014 Feb 5;3(2):e98. doi: 10.1038/psp.2013.74.
• Background Danilova E, Shiryayev A, Kristoffersen EK, Sjursen H. Attenuated immune response to tetanus toxoid in young healthy men protected against tetanus. Vaccine. 2005 Oct 10;23(42):4980-3. doi: 10.1016/j.vaccine.2005.05.028.

Drugs

Indications