Td vaccine (4 ug) + Entolimod (1 ug) (n=25)

Substance Use Disorders

The objective is to compare adverse events and anti-tetanus (TT) antibody levels between patients getting entolimod vs no entolimod combined with tetanus-diphtheria (Td) vaccine. This clinical trial in 40 normal health subjects 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 (1μg).

Entolimod

Td Vaccine

Baylor College of Medicine

Entolimod, an Adjuvant for Vaccine Augmentation

The proposed dose of entolimod used in our study is 30-40 times lesser than that previously given safely to humans. Although our pre-clinical data suggest that these very low levels of entolimod efficiently enhances the antibody levels to TT vaccine in rodents, the safety and success rate at these low doses of entolimod to enhance anti-TT AB in humans requires examination.

This study will analyze level of anti-TT AB and anti-diphtheria AB and compare both study arms at 6 weeks post vaccination to baseline AB levels to determine the immune potentiating capability of entolimod. We expect the AB levels at 6 weeks post vaccination and the ratio of 6-week to baseline AB levels from Td+entolimod (n=25) to be at least double the levels from Td alone (n=15).

Thomas R. Kosten, MD

Waggoner Chair and Professor of Psychiatry, Neuroscience, Pharmacology, Immunology & Pathology Director, Dan Duncan Institute for Clinical and Translational Research

aluminum phosphate/hitasótt

Entolimod, an Adjuvant for Vaccine Augmentation

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