Personalized Immunotherapeutic for Antibiotic-resistant Infection

NCT02508584 | Completed Early Phase 1

• 1 other identifier: 2015P001027
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection; Immune Deficiency; Hypogammaglobulinemia; Septic Arthritis; Mycoplasma Hominis

Outcome Measures

Primary Outcomes (3)

• 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

• Patency of fistula as assessed by clinical exam

  see publication below

  from date of initiation of therapy up to 1 year

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

This is a single patient treatment IND

Biological: anti-mycoplasma hominis antibodies

Interventions

anti-mycoplasma hominis antibodies BIOLOGICAL

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

Intervention

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hosptial

Boston, Massachusetts, 02115, United States

Location

Related 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.

  PMID: 29272362 RESULT

MeSH Terms

Conditions

Infections; Immunologic Deficiency Syndromes; Agammaglobulinemia; Arthritis, Infectious

Condition Hierarchy (Ancestors)

Immune System Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Duane R. Wesemann, MD, PhD

  Brigham and Women's Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician and Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: July 27, 2015
• Study Start: April 12, 2016
• Primary Completion: June 12, 2019
• Study Completion: June 12, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

US (1)