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NCT01339000 · ClinicalTrials.gov registry record · Phase 2
Improving the Immune System With Human IL-7 Vaccine in Older Subjects Who Have Had Chemotherapy
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT01339000: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01339000 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01339000, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: Drugs given to treat cancer (chemotherapy) can weaken the human immune system. But it can also become weaker because of aging. Interleukin (IL)-7, a molecule produced naturally in the body, can help improve the function of the immune system. Researchers want to study the effects of IL-7 on immune system function in two different groups of older people. One group will be people who have received vaccines before IL-7. The other group will be people who have received Vaccines after IL-7. Objectives: To evaluate the effect of IL-7 on the immune system responses to vaccines in older people following chemotherapy. Eligibility: People at least 60 years of age who have recently finished chemotherapy for breast, colon, or bladder cancer. Design: * People in the study will be screened with a physical examination, medical history, and blood tests. Other screening tests, such as tumor imaging, may also need to be performed. * Everyone will receive a series of five different vaccines commonly used to prevent diseases. We will compare the responses of people in Sequence 1 who will receive vaccines before IL-7 with the responses of people in Sequence 2 who received the same vaccines after IL-7. * The vaccines will be given randomly in two Arms at different times. * Arm 1: diphtheria and tetanus, polio, pneumonia (with two booster shots), hepatitis B (with two booster shots), and hepatitis A (with one booster shot), * Arm 2: hepatitis A (with one booster shot), hepatitis B (with two booster shots), pneumococcal (with two booster shots), diphtheria and tetanus, polio, pneumonia (with two booster shots) * There are 5 vaccines to be given to each subject, following one of two randomly assigned sequences of vaccine administration (Sequence 1 or Sequence 2). * The first vaccine arm contains the two diphtheria protein containing vaccines tetanus and diphtheria (Td) and pneumococcal conjugate 13 (PCV13) and polio. The second vaccine arm contains the Hepatitis A and He
Interventions
- BIOLOGICAL Hepatitis A Vaccine
- BIOLOGICAL Pneumococcal Vaccine
- DRUG Glycosylated Recombinant Human Interleukin-7
- BIOLOGICAL Diphtheria/Tetanus Vaccine
- BIOLOGICAL Polio Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2011-04 |
| Est. Completion | 2016-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01339000
The ClinicalTrials.gov registry entry for NCT01339000 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Hepatitis A Vaccine is the first listed.
NCT01339000 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01339000 about?
NCT01339000 is a clinical study titled "Improving the Immune System With Human IL-7 Vaccine in Older Subjects Who Have Had Chemotherapy". Background: Drugs given to treat cancer (chemotherapy) can weaken the human immune system. But it can also become weaker because of aging. Interleukin (IL)-7, a molecule produced naturally in the body, can help improve the function of the immune system. Researchers want to study the effects of IL-7 ...
What is the current status of trial NCT01339000?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2011-04. Estimated completion is 2016-04.
What interventions are being tested in trial NCT01339000?
The interventions under investigation include: Hepatitis A Vaccine (BIOLOGICAL), Pneumococcal Vaccine (BIOLOGICAL), Glycosylated Recombinant Human Interleukin-7 (DRUG), Diphtheria/Tetanus Vaccine (BIOLOGICAL), Polio Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01339000?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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