Recombinant DNA Advisory Committee - 2/10-11/92 
Dr. Krogstad stated that a request was being made to change the classification 
Mycobacterium avium from a Class III to a Class II bacterial agent. This change in 
classification would bring the NIH and CDC biosafety guidelines into conformity with one 
another. 
Review-Dr. Hirano 
Dr. Hirano stated that the basis of this request resides in the fact that CDC-NIH biosafety 
guidelines that were published in 1984, recommended Biosafety Level 2 practices for M. 
avium. M. avium is ubiquitous in nature, a common contaminant in the soil; and there is 
no evidence that direct transmission occurs between humans. 
Committee motion 
Dr. Hirano made the motion to lower the classification of Mycobacterium avium from a 
Class in bacterial agent to a Class II bacterial agent. M. avium would move from 
Appendix B-I-C-l to Appendix B-I-B-l in the NIH Guidelines. Dr. Krogstad seconded. 
The motion passed by a vote of 14 in favor, 0 opposed, and no abstentions. 
X. PROPOSED ADDITION TO APPENDIX D OF THE NIH GUIDELINES REGARDING A 
HUMAN GENE THERAPY PROTOCOL ENTITLED: A PHASE I/II STUDY OF 
CELLULAR ADOPTIVE IMMUNOTHERAPY USING GENETICALLY MODIFIED 
CD8+ HIV-SPECIFIC T-CELLS FOR HIV-SEROPOSITIVE PATIENTS UNDERGOING 
ALLOGENEIC BONE MARROW TRANSPLANT 
Review— Dr. Mclvor 
Dr. Mclvor stated that this protocol was unconditionally approved by the HGTS. The 
protocol has been devised for patients who are human immunodeficiency virus (HIV) 
positive and undergoing BMT for lymphoma. The BMT would be conducted to eradicate 
the lymphoma, eliminate some HIV-infected cells, and prevent the spread of acquired 
immune deficiency syndrome (AIDS). The patients would also receive the antiviral agent, 
azidothymidine (AZT). Additionally, the patients would be treated with clones of T-cells 
that have been activated in vitro against the HIV gag protein. The T-cells would be 
expanded in culture and then reinfused into the patient following bone marrow 
engraftment. 
The T-cell clones could demonstrate substantial cytotoxicity since a number of different 
tissues are infected with HIV. Before the T-cell clones are reinfused, they will be 
transduced with a recombinant retrovirus which was constructed by ligating the hygromycin 
phosphotransferase (Hy) and herpes simplex virus thymidine kinase gene (HSV-1 TK). If 
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