An Early Phase 1 interventional study of anti-mycoplasma hominis antibodies in Infection, Immune Deficiency and Hypogammaglobulinemia, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Brigham and Women's Hospital · Early Phase 1, Interventional, and Treatment
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.
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.
6,702 studies on the registry are indexed under Infections; 801 are open to participants now.
This study's enrollment of 1 is below the median of 120 across 4,205 interventional studies indexed under Infections.
Browse Infections studies →Brigham and Women's Hospital is the lead sponsor of 1,263 studies on the registry; 225 are open to participants now.
Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.
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Exclusion Criteria:
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.
Presence or absence of mycoplasma hominis cultured from joint and wound fluid
see publication below
Time frame: from date of initiation of therapy up to 1 year
Patency of fistula as assessed by clinical exam
see publication below
Time frame: 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
Time frame: from date of initiation of therapy up to 1 year
Ran from Apr 2016 to primary completion in Jun 2019, 38 months.
Of 83 non-industry phase 1 interventional studies under Infections, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 38 months is above that.
Counting every sponsor, half of 166 studies reached it within 16 months; a quarter within 7 and three quarters within 29.
Infections covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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