Entolimod, an Adjuvant for Vaccine Augmentation

• Status: Completed
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Vaccines

Criteria

Inclusion Criteria:

1. Healthy, non-patient normal males between 18 and 40 years of age

2. No baseline anti-TT AB (tetanus toxoid antibody) levels greater than 5 µg/ml

3. Able to read/write/understand English and provide signed written informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Inability to read/write English

2. Inability to provide written informed consent.

3. Any major cardiovascular, renal, endocrine, immunological (including positive test result for human immunodeficiency virus types 1 or 2 antibodies) or hepatic disorder (including positive test result for hepatitis B, hepatitis C virus antibodies, or liver function tests (LFT's)(SGOT, SGPT) that are 20% greater than normal levels or history of severe alcohol use disorder (defined as a score of 5 of greater on the MINI, based on DSM criteria).

4. Medical contraindication to treatment with vaccine as indicated by a history of autoimmune disease, immune deficiency, or hypersensitivity to other vaccines. Specific disorders include a prior Arthus-type hypersensitivity reaction to tetanus vaccine or any of its components, prior Guillain-Barre Syndrome, Ongoing active infection of any kind with clinical signs of febrile illness (temperature >99.5ºF).

5. Use of psychoactive or hepatotoxic medications or medications that might interact with the tetanus toxoid based vaccine including steroids within 30 days of screening, immunosuppressive or immunostimulant therapy.

6. Received other vaccines, including flu vaccine, within 30 days prior to screening or Tetanus vaccine within 5 years of this study (Advisory Committee on Immunization Practices (ACIP) guidelines.

7. Blood or blood products given in the 3 months prior to vaccination.

8. Participation in another investigational pharmaceutical trial within 30 days prior to screening.

9. Greater than Grade 1 abnormality in baseline safety labs (e.g, CBC and CMP), as defined using the FDA Guidance Document entitled "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventative Vaccine Clinical Trials"

10. Greater than Grade 1 abnormality in baseline vital signs

11. Women, as a standard safety measure, will be excluded from the study due to childbearing potential and to minimize the effects of differences in hormonal levels during the menstrual cycle and of sex differences in antibody titer responses to vaccines. Furthermore, our sample size is too small to control for these effects in women.

12. Other concerns that in the PI's judgment will be a potential safety issue for the subject including cognitive impairment that precludes the ability to provide informed consent, and individuals with behavioral issues evidenced during screening or through the course of the trial that are disruptive and/or pose a safety concern to self or other subjects.