Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies

This study aims to provide long-term follow-up care of patients previously enrolled in a
vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that
can be used to introduce specific genes into genetic makeup. The study does not involve the
use of any drug or biologic agent. Participants will undergo an annual health history.
Because certain viruses enter into cells and create proteins from the viral genes, the type
of vaccine treatment used is referred to gene therapy. The genes expressed by poxviral
vectors do not become part of the genetic material left behind. Because gene therapy is a
somewhat new technology, a prolonged monitoring of patients' health status is necessary,
according to new specific reporting requirements for harmful events in patients who undergo
such gene therapy studies. The risk of any long-term negative effects from the gene therapy
that patients had received is quite small. Still, it is important that there be updates at
least annually. This annual monitoring of health status will extend for 15 years, according
to guidelines from the Food and Drug Administration, or for as long as patients are willing
to participate.

Patients who received poxviral vectors (vaccinia or fowlpox, or both) at the National Cancer
Institute, through a trial affiliated with the Laboratory of Tumor Immunology and Biology,
may be eligible for this study.

Participants will be involved in the following forms of data collection:

- Annual medical history and physical examinations for the first 5 years following the
last vaccine.

- Annual telephone contact during the last 10 years.

- Health status check, including primary cancer status, secondary malignancies, neurologic
disorders, autoimmune disorders, and hematologic disorders.

- Blood tests for the presence of HIV antibodies.

- Reporting of medical problems, including information on unexpected hospitalizations and
medications.

If a participant has died, the study will document the cause of death and autopsy information
if available.