Personalized Immunotherapeutic for Antibiotic-resistant Infection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infection Agammaglobulinemia Arthritis Arthritis, Infectious Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hypogammaglobulinemia Immune Deficiency Immune System Diseases Immunologic Deficiency Syndromes Infections Joint Diseases Lymphatic Diseases Lymphoproliferative Disorders Musculoskeletal Diseases Mycoplasma Hominis Septic Arthritis

Sex eligibility

Male

Study type

Interventional

Phase

Early Phase 1

Primary location

Brigham and Women's Hosptial

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

anti-mycoplasma hominis antibodies

Biological

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

Primary outcomes

Presence or absence of mycoplasma hominis cultured from joint and wound fluid

Time frame: from date of initiation of therapy up to 1 year

see publication below
Patency of fistula as assessed by clinical exam

Time frame: from date of initiation of therapy up to 1 year

see publication below
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

see publication below

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Jul 27, 2015
Registry last updated: Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed