Improving the Immune System With Human IL-7 Vaccine in Older Subjects Who Have Had Chemotherapy

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 Hepatitis B vaccines. Subjects will either get tetanus, diphtheria, polio, and pneumonia vaccines before IL-7 therapy (Sequence 1) or hepatitis A and hepatitis B vaccines before IL-7 therapy (Sequence 2). The response to vaccines will be evaluated 4 weeks after vaccination. This will be followed by IL-7 therapy, then administration of the other group of vaccines. Therefore, subjects on both arms will receive the same set of vaccines, just at different times with respect to IL-7 therapy.

Conditions

• Breast Cancer
• Colon Cancer
• Bladder Cancer

Interventions

DRUG

Glycosylated Recombinant Human Interleukin-7

Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection

BIOLOGICAL

Diphtheria/Tetanus Vaccine

Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.

BIOLOGICAL

Polio Vaccine

Polio Vaccine will be administered according to the randomized schedule per protocol.

BIOLOGICAL

Pneumococcal Vaccine

Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.

BIOLOGICAL

Hepatitis A Vaccine

Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.

BIOLOGICAL

Hepatitis B Vaccine

Hepatitis B vaccine will be administered according to the randomization schedule per protocol.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Ronald E Gress, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-04-30

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• United States

Study Locations