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临床试验/NCT03402776
NCT03402776Unknown3 期

Impact of a Fourth Hexavalent Vaccine Dose During Primary Vaccination After Haematopoietic Stem Cell Transplantation

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
200
试验地点
1
主要终点
antibody response 1 month after the one year booster dose

研究概览

简要总结

It is recommended for patients who underwent an hematopoietic stem cell transplantation to receive 6 months after the graft 3 injections of hexavalent vaccine (diphteria-tetanus- poliomyelitis-pertussis-Hib-HBV) within 2 months followed by a booster dose one month after. The patients included in the study will have a measure of their antibody level against 5 pathogens (diphteria toxin, tetanus toxin, Haemophilus influenza b, hepatitis B virus, poliomyelitis virus) one month after the 3rd injection of hexavalent vaccine. If the antibody response is not sufficient, they will be randomized for a 4th dose in the following month. The antibody response will be again measured one month after the 1 year booster dose.

详细描述

It is recommended for patients who underwent an hematopoietic stem cell transplantation to receive, 6 months after the graft, 3 injections of hexavalent vaccine (diphteria-tetanus- poliomyelitis-pertussis-Hib-HBV) within 2 months, followed by a booster dose one yrar after. However, this strategy do not constantly lead to efficient antibody levels.

the investigators aim to determine whether a 4th dose in the initial vaccine schedule (month 0, 1, 2, and 3) allows to obtain a better response.

After informed consent, the investigators will recruit 6 months after the graft 200 patients who had received an hematopoietic stem cell transplantation . The participants will have a measure of their antibody level against 5 pathogens (diphteria toxin, tetanus toxin, Haemophilus influenza b, hepatitis B virus, poliomyelitis virus) at month 0 (before the 1st hexavalent vaccine injection), and one month after the 3rd injection of this vaccine. If the antibody response is not sufficient, they will be randomized for a 4th dose in the following month.

The one year booster dose will be then injected to all participants, and the antibody response will be again measured one month after this dose. The primary endpoint is to compare the antibody levels at this date in patients who had an unsufficient immune response after the 3rd dose and who received or not a 4rth dose in the initial vaccine schedule.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • having received an HSTC 6 months before (not more than 2 years)
  • not receiving immunosuppressive therapy at inclusion

排除标准

  • having received an HSTC 6 months more than 2 years before
  • receiving immunosuppressive therapy at inclusion

研究组 & 干预措施

bad resp. after 3 vacc. inj., 4th inj

Experimental

After randomization, these patients will receive a 4th dose one month after the 3rd dose.

干预措施: 4th dose of hexavalent vaccine 1 month after the 3rd dose (Drug)

结局指标

主要结局

antibody response 1 month after the one year booster dose

时间窗: 1 month after the one year booster dose

antibody level against 5 pathogens (diphteria toxin, tetanus toxin, Haemophilus influenza b, hepatitis B virus, poliomyelitis virus) one month after the 3rd injection of hexavalent vaccine

次要结局

未报告次要终点

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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