June 26, 1992 (Donor) 
Consent for protocol entitled “A Study of the Safety and Survival of the 
Adoptive Transfer of Genetically Marked Syngeneic Lymphocytes in HIV 
Infected Identical Twins” 
You are invited to participate in a study to evaluate the safety and side effects of 
administering genetically modified white blood cells (lymphocytes) to individuals with 
HIV-1 infection . You are invited to participate in this study because you have an 
identical twin who is infected with HIV-1 and because you test negative for HIV. 
To participate in this study, your history, physical examination, and laboratory 
studies must show that you are able to provide informed consent and that you are in 
good health. If you have used drugs or alcohol to excess in the past, or if you are 
currently using these substances, you must agree to refrain from any further use and 
may be asked to participate in regular substance abuse counseling and/or therapy. 
This study has been designed to evaluate the safety and tolerance of 
administering lymphocytes that have been removed from your blood, marked (or 
labelled) with a new gene in the lab, stimulated to grow to large numbers of cells in 
cell cultures, and then infused into your twin. We hope to learn not only about the 
safety of such cell transfers, but also about how long these gene marked cells will 
survive in the bloodstream after being treated in this way. 
After you and your twin have had screening blood tests, a tetanus booster 
injection, and a complete history and physical examination performed at the NIH, you 
will be scheduled to have a fraction of your lymphocytes removed from the blood by a 
procedure called “lymphapheresis.” This will be performed in the Apheresis Unit of the 
NIH Blood Bank. These lymphocytes will then be separated into CD4 (T4) and CD8 
(T8) cells and grown separately in the lab. After 1 to 4 days, a new gene will be 
introduced into the cells. The process involved in introducing the new gene is 
accomplished by first inserting the gene into a vector (i.e., an organism that carries 
material from one cell to another). This vector is prepared from a disabled mouse 
retrovirus. The vector is mixed with the cells in the laboratory, enters the cells, and 
inserts the new gene into the cells’ genetic material (chromosomes). Once Inserted, 
the new gene will survive as long as the cell survives. The new gene that will be used 
is derived from bacteria and will enable the cells that contain it to resist the cell-killing 
effects of the antibiotic neomycin (neoR gene). This gene is being selected for use in 
this study because it has been used safely and successfully in a number of other 
human and animal studies. By inserting the neoR gene into the lymphocytes, we will 
be able to distinguish these modified lymphocytes from those normally produced in the 
body after the cells have been infused into your sibling’s bloodstream. We plan to use 
two different neoR genes, which both make cells resistant to neomycin but which differ 
from each other in terms of their molecular structure, to mark your cells. One neoR 
gene will be used to mark CD4 cells, while the other neoR gene will be used to mark 
Recombinant DNA Research, Volume 16 
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