Personalized Immunotherapeutic for Antibiotic-resistant Infection

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02508584
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Actual Duration (Months): 38
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

1. 1. 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

1. 1. 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.

1. 1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Personalized Immunotherapeutic for Antibiotic-resistant Infection
• Actual Study Start Date: Apr 12, 2016
• Actual Primary Completion Date: Jun 12, 2019
• Actual Study Completion Date: Jun 12, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Presence or absence of mycoplasma hominis cultured from joint and wound fluid [from date of initiation of therapy up to 1 year]

   see publication below

2. Patency of fistula as assessed by clinical exam [from date of initiation of therapy up to 1 year]

   see publication below

3. Pain reduction as measured by pain scale and amount of pain medication required [from date of initiation of therapy up to 1 year]

   see publication below

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hosptial	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Duane R. Wesemann, MD, PhD, Brigham and Women's Hosptial

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Deployment of Transchromosomal Bovine for Personalized Antimicrobial Therapy

Publications

None provided.

• Responsible Party: Duane Robert Wesemann, Associate Physician and Assistant Professor of Medicine, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02508584
• Other Study ID Numbers: 2015P001027
• First Posted: Jul 27, 2015
• Last Update Posted: Jan 18, 2020
• Last Verified: Jan 1, 2020

• Additional relevant MeSH terms: Infections; Communicable Diseases; Arthritis, Infectious; Agammaglobulinemia; Immunologic Deficiency Syndromes; Antibodies

Study Results

No Results Posted as of Jan 18, 2020