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Personalized Immunotherapeutic for Antibiotic-resistant Infection

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ClinicalTrials.gov Identifier: NCT02508584
Recruitment Status : Unknown
Verified January 2017 by Duane Robert Wesemann, Brigham and Women's Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : July 27, 2015
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Duane Robert Wesemann, Brigham and Women's Hospital

Brief Summary:
M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures. The investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB Biotherapeutics), purify human antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.

Condition or disease Intervention/treatment Phase
Infection Immune Deficiency Hypogammaglobulinemia Septic Arthritis Mycoplasma Hominis Biological: anti-mycoplasma hominis antibodies Early Phase 1

Detailed Description:

M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure.

Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures.

SAB Biotherapeutics, Inc. (formerly Sanford Applied Biosciences, LLC) located in Sioux Falls, SD, have developed transchromosomic (Tc) cows containing human immunoglobulin (Ig) heavy (IgH) and light (IgL) chain loci in the setting of inactivated bovine IgH and Ig lambda loci. To date, SAB Biotherapeutics (SAB) has several products in development that have been tested in animal models, but to date no human trials.

Investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow, purify antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.

M. A. is a highly educated person with full decision making capacity and is well aware of the uncertainties and risks associated with this treatment. This proposal is designed to offer this patient an alternative and perhaps curative approach to his disease.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Immunotherapeutic for Antibiotic-resistant Infection
Actual Study Start Date : April 12, 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Intervention
This is a single patient treatment IND
Biological: anti-mycoplasma hominis antibodies
provision of customized anti-mycoplasma hominis antibodies in the context of a treatment IND.




Primary Outcome Measures :
  1. Presence or absence of mycoplasma hominis cultured from joint and wound fluid [ Time Frame: from date of initiation of therapy up to 1 year ]
  2. Patency of fistula as assessed by clinical exam [ Time Frame: from date of initiation of therapy up to 1 year ]
  3. Pain reduction as measured by pain scale and amount of pain medication required [ Time Frame: from date of initiation of therapy up to 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult with decision making capacity afflicted with chronic mycoplasma hominis septic arthritis despite standard treatments.

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508584


Locations
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United States, Massachusetts
Brigham and Women's Hosptial
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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Principal Investigator: Duane R. Wesemann, MD, PhD Brigham and Women's Hosptial

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Responsible Party: Duane Robert Wesemann, Associate Physician and Assistant Professor of Medicine, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02508584     History of Changes
Other Study ID Numbers: 2015P001027
First Posted: July 27, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis, Infectious
Agammaglobulinemia
Immunologic Deficiency Syndromes
Arthritis
Joint Diseases
Musculoskeletal Diseases
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Anti-Bacterial Agents
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Anti-Infective Agents