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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 15 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Subjects will undergo an annual health history for up to 15 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks long-term health in adults who received certain vaccines or immune system treatments in earlier cancer studies. It gives no study drug or vaccine. Health checks happen each year for up to 15 years, or as long as people are willing to take part.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You received a poxvirus-based vaccine, another vaccine that delivers genes, or another immune system treatment in an eligible earlier trial.
  • That trial was linked to GMB, UOB, or LTIB at the National Cancer Institute, or you received these treatments at an outside site in a trial run at several locations.

Who can't join

  • You are not willing to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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.)

Study sites (1)

MD