A clinical phase IV trial to examine cellular and humoral immunity against measles and chickenpox in children and adolescents 0-18 years in childhood cancer.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 7
- 主要终点
- Difference in VZ IgG antibody levels before and after revaccination against chickenpox
研究概览
简要总结
Primary aim
-
Immunity after revaccination with vaccine aganist varicella, after treatment against childhood cancer. Measured by IgG antibodies to VZV before and after vaccination. (Proportion (%) of patients with protective level of VZ-IgG after vaccination – proportion (%) of patients with protective level of VZ-IgG before vaccination).
-
Immunity after revaccination with vaccine against measles, after treatment against childhood cancer. Measured by IgG antibodies to morbilli before and after vaccination. (Proportion (%) of patients with protective morbilli-IgG level after vaccination – proportion (%) of patients with protective morbilli-IgG level prior to vaccination).
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •Children and adolescents (0-18.0 years) initiating cancer treatment through the childrens cancer centre in Gothenburg.
- •Vaccination status for measles and chickenpox before cancer treatment is known.
- •Oral and written information about the trial along with signed consent
- •Female participants of reproductive age with menarche who are sexually active must consent to using effective contraception and have a negative pregnancy test at the times of all vaccinations. (Effective contraception refers to combined preparations with estrogen and progesterone taken orally, intravaginal ring, known as the p-ring, or preparations used transdermally, such as the contraceptive patch. Contraception with progesterone taken orally, via injections, or implants such as the contraceptive implant. Intrauterine hormone-releasing coil or copper coil. Completed sterilization with blockage of both fallopian tubes. Sexual abstinence)
排除标准
- •Known primary immunodeficiency.
- •Ongoing treatment with immunomodulatory or immunosuppressive agents
- •Patients planned for relapse therapy or stem cell transplantation (SCT)
- •Known contraindication to any of the proposed vaccines.
- •Female participants with an ongoing pregnancy at diagnosis or during the study
- •Ongoing breastfeeding.
结局指标
主要结局
Difference in VZ IgG antibody levels before and after revaccination against chickenpox
Difference in VZ IgG antibody levels before and after revaccination against chickenpox
Difference in measles IgG antibody level before and after revaccination against measles
Difference in measles IgG antibody level before and after revaccination against measles
次要结局
- Percentage of patients with immunity against chickenpox and measles before and after treatment measured in IgG
- Changes in cellmediated immunity (CMI) against chickenpox and measles before and after revaccination. Comparisons with a healthy control group.
- Differences in antibody levels and CMI between various diagnostic groups (leukemias, solid tumors), different age groups, low- vs. high-intensity treatment, and pre-immune versus non-immune groups
研究者
Torben Ek
Scientific
Vaestra Goetalandsregionen