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Entolimod, an Adjuvant for Vaccine Augmentation

NCT03063736 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-09-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Entolimod

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).

BIOLOGICAL

Td Vaccine

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).

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Thomas Kosten, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-12-08
Primary Completion
2018-03-09
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03063736 on ClinicalTrials.gov