Personalized Immunotherapeutic for Antibiotic-resistant Infection

Infection Clinical Trial

Official title:

Personalized Immunotherapeutic for Antibiotic-resistant Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02508584
• Other study ID #: 2015P001027
• Status: Completed
• Phase: Early Phase 1
• Start date: April 12, 2016
• Est. completion date: June 12, 2019

Study information

• Verified date: January 2020
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 12, 2019
• Est. primary completion date: June 12, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Agammaglobulinemia
• Arthritis, Infectious
• Communicable Diseases
• Hypogammaglobulinemia
• Immune Deficiency
• Immunologic Deficiency Syndromes
• Infection
• Mycoplasma Hominis
• Septic Arthritis

Intervention

Biological:
• anti-mycoplasma hominis antibodies
provision of customized anti-mycoplasma hominis antibodies in the context of a treatment IND.

Locations

Country	Name	City	State
United States	Brigham and Women's Hosptial	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

Silver JN, Ashbaugh CD, Miles JJ, Wu H, Marecki GT, Hwang JK, Jiao JA, Abrams M, Sullivan EJ, Wesemann DR. Deployment of Transchromosomal Bovine for Personalized Antimicrobial Therapy. Clin Infect Dis. 2018 Mar 19;66(7):1116-1119. doi: 10.1093/cid/cix977. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence or absence of mycoplasma hominis cultured from joint and wound fluid	see publication below	from date of initiation of therapy up to 1 year
Primary	Patency of fistula as assessed by clinical exam	see publication below	from date of initiation of therapy up to 1 year
Primary	Pain reduction as measured by pain scale and amount of pain medication required	see publication below	from date of initiation of therapy up to 1 year

External Links

•   Deployment of Transchromosomal Bovine for Personalized Antimicrobial Therapy