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Investigator(s):
Claude Sportès, M.D. Principal Investigator Phone: 301-435-5280 Fax: 301-402-7515 csportes@mail.nih.gov
Referral Contact(s):
Zetta Blacklock, R.N., B.S., B.S.N. Transplant Coordinator Phone: 301-594-2056 Fax: 301-451-5578 bblacklock@mail.nih.gov	Sheila Phang, R.N., M.S. Phone: 301-435-9379 Fax: 301-451-5578 sphang@mail.nih.gov

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Key Eligibility Criteria:

• Age ≥ 60
• Healthy volunteer or documented diagnosis of any of the following:
• Non-metastatic breast carcinoma following neo-adjuvant chemotherapy and appropriate surgery or following adjuvant radiotherapy/chemotherapy
• Stage II or III (Dukes B or C) colon carcinoma following appropriate surgery and adjuvant chemotherapy
• Stage II bladder carcinoma following neo-adjuvant radiotherapy/chemotherapy and appropriate surgery or following adjuvant radiotherapy/chemotherapy; patients with recurrent tumors are not eligible
• Completed cancer specific therapy (including surgery, radiotherapy and/or chemotherapy) at a minimum 4 weeks and at most 6 months prior to entry; (breast cancer patients maintained on hormonal therapy are eligible)
• Reasonable expectation that no chemotherapy will be given in the subsequent 6 months (PI’s discretion)
• No prior allogeneic hematopoietic stem cell (HSC) or solid organ transplantation
• No diphtheria and tetanus (DT) vaccine in the previous 5 years
• No significant heart disease or history of autoimmune disease

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Study Outline:

• Participants will receive 2 groups of immunizations 7 weeks apart
• Vaccine Group 1 contains: diphtheria/tetanus; polio (killed); PCV (pneumococcal)
• Vaccine Group 2 contains: hepatitis A #1; hepatitis B # 1; influenza (seasonal); bacteriophage Phi X 174
• Participants will be randomized (chosen by chance) to receive these vaccine groups in different sequences:
• Administration Sequence 1: Group 1 first; Group 2 after rhIL-7 administration
• Administration Sequence 2: Group 2 first; Group 1 after rhIL-7 administration

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/6/12
Updated: 2/21/12