DNA from AdCFTR will not replicate. 
(4) Include in the protocol only individuals with demonstrated anti- 
adenovirus type 5 antibodies in blood. While this will not ensure 
absolute protection should recombination to a replication competent 
adenovirus occur, the presence of anti-Ad5 antibodies in blood is 
evidence of prior exposure to Ad5 (or a cross-reacting Ad serotype), 
and likely provides some additional measure of safety compared to an 
individual that has no anti-Ad5 antibodies (see Table 5.2-A). 
(5) After inclusion in the protocol, the patients will be clinically 
isolated for 10 days prior to being treated with the vector (i.e., to 
prevent exogenous viral infection) and will be clinically evaluated 
prior to administration of the vector to ensure there is no 
intercurrent viral illness. Isolation will entail restriction to the 
individual's hospital room on the 7W patient care unit as much as 
possible. Visitors to the room must be 15 years or older. All visitors 
and hospital personnel will wear gown, mask, and gloves. When the 
individual leaves the room, he/she will wear a mask and gloves and be 
accompanied by hospital medical/nursing staff. 
(6) After administration of the vector, the patient will be kept in 
isolation until demonstrated not to be shedding the vector or 
replication competent adenovirus from the nose, pharynx or rectum on 3 
separate days. 
(7) The patient rooms to be used on the 7W ward will be converted so as to 
be pressure negative relative to the corridor, and have air leaving 
the rooms appropriately filtered, thus minimizing risk of release to 
the environment. 
(8) Patients will not be included who are taking corticosteroid or other 
known immunosuppressive medications. 
(9) In regards to the environment, it is recognized that following the 
administration of AdCFTR should the study individual wish to leave 
isolation conditions and/or the Clinical Center prior to the 
demonstration of a lack of shedding of AdCFTR or an AdCFTR- derived 
virus, the physicians caring for the study individual cannot compel 
that individual to remain. The one exception to this is the 
extraordinarily unlikely, but theoretically possible, circumstance 
where the physicians caring for the study individual believe that due 
to an untoward event, AdCFTR combined with another virus or other 
genetic information to create a new virus that was believed to be 
dangerous to others. In this event, the NIH Clinical Center 
regulations allow the physicians to keep the study individual against 
their will for up to 72 hours. During that period they would have the 
option to ask for a court order to keep the study individual confined 
until the risk to others is over. The risks to the environment and 
this general concept are discussed in detail in section 4.9. This 
theoretical scenario will be explicitly explained to the study 
individual and is in the informed consent document. 
Recombinant DNA Research, Volume 16 
[739] 
