No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
750 (estimated)
Sponsor
National Cancer Institute (NCI) · NIH
Who this trial is looking for
This trial is looking for patients who have previously received poxviral vector treatments for cancer. Participants will be monitored annually for 15 years to ensure their ongoing health and safety.
Are You a Good Fit for This Trial?
You may be able to join if
I have received poxviral vectors (vaccinia and/or fowlpox) through a trial at the National Cancer Institute.
I am at least 18 years old.
You may not be able to join if
I am unwilling to participate.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 cell…
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.
Trial Locations
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Eligibility Criteria
* INCLUSION CRITERIA:
* Subjects who received poxviral vectors (vaccinia and/or fowlpox) or other vaccines utilizing gene transfer or any other immunotherapeutic agent through GMB, UOB and LTIB affiliated trials at the National Cancer Institute, as well as subjects at extramural sites receiving thes…
* INCLUSION CRITERIA:
* Subjects who received poxviral vectors (vaccinia and/or fowlpox) or other vaccines utilizing gene transfer or any other immunotherapeutic agent through GMB, UOB and LTIB affiliated trials at the National Cancer Institute, as well as subjects at extramural sites receiving these agents as part of a multi-site trial. Available stored specimens obtained from NCI participants in GMB, UOB, and LTIB affiliated protocols may be transferred to this protocol for storage and eventual future research use.
* Subjects must be \>= 18 years of age.
EXCLUSION CRITERIA:
Participants unwilling to participate.
(Please note, participants may participate in this protocol and, at the same time, participate in an active treatment or continuing care study.)
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