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 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.

背景：用于治疗癌症的化疗药物会削弱人体免疫系统，而衰老同样会导致免疫系统功能减退。白细胞介素（Interleukin, IL）-7是一种人体天然产生的分子，可助力改善免疫系统功能。研究人员拟针对两类老年人群体，探究IL-7对其免疫系统功能的影响：一组将在接受IL-7治疗前接种疫苗，另一组则在接受IL-7治疗后接种疫苗。
研究目标：评估IL-7对化疗后老年人群体针对疫苗的免疫系统应答效果的影响。
入组标准：年龄至少60岁，且近期已完成乳腺癌、结肠癌或膀胱癌化疗的人群。
试验设计：
* 所有受试者将通过体格检查、病史问询及血液检测完成筛查，部分受试者可能还需完成肿瘤影像学等其他筛查项目。
* 所有受试者将接种5种临床常用的疾病预防疫苗。本研究将对比两组人群的免疫应答：序列1组将在IL-7治疗前接种疫苗，序列2组则在IL-7治疗后接种同款疫苗。
* 疫苗将通过随机分组的两个队列（Arm）在不同时序接种：
* 队列1（Arm 1）：白喉-破伤风联合疫苗、脊髓灰质炎疫苗、肺炎疫苗（含2剂加强针）、乙型肝炎疫苗（含2剂加强针）及甲型肝炎疫苗（含1剂加强针）
* 队列2（Arm 2）：甲型肝炎疫苗（含1剂加强针）、乙型肝炎疫苗（含2剂加强针）、肺炎疫苗（含2剂加强针）、白喉-破伤风联合疫苗、脊髓灰质炎疫苗
* 每位受试者将接种5种疫苗，接种顺序为两种随机分配序列之一（序列1或序列2）。
* 第一疫苗队列包含含白喉蛋白的破伤风-白喉联合疫苗（Td）、13价肺炎球菌结合疫苗（PCV13）及脊髓灰质炎疫苗；第二疫苗队列包含甲型肝炎及乙型肝炎疫苗。受试者将分为两类：一类在IL-7治疗前接种破伤风、白喉、脊髓灰质炎及肺炎疫苗（序列1），另一类则在IL-7治疗前接种甲型肝炎及乙型肝炎疫苗（序列2）。疫苗接种后的免疫应答将在接种后4周进行评估。随后受试者将接受IL-7治疗，再接种剩余组别疫苗。因此，两个队列的受试者将接种完全相同的疫苗组合，仅在IL-7治疗前后的接种时序上存在差异。