RecruitingNCT00451022

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

Follow-Up Study of Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents


Sponsor

National Cancer Institute (NCI)

Enrollment

750 participants

Start Date

Sep 13, 2004

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This follow-up study tracks the long-term health of people who previously received an experimental cancer vaccine based on a modified pox virus, to check for any lasting effects. **You may be eligible if...** - You previously participated in a clinical trial involving a poxviral cancer vaccine - You are willing to provide blood samples and health updates at follow-up intervals - You have no current serious health issues that would prevent follow-up **You may NOT be eligible if...** - You did not participate in a qualifying previous poxviral vaccine trial - You are unable or unwilling to be contacted for follow-up - You have developed a serious immune system disorder since your original enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT00451022


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