Immune Response After Inactivated Oral Cholera Vaccine (Dukoral) in Renal Transplant Recipients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Percentage seroconversion among all renal transplant recipients.
研究概览
简要总结
The aim of this study is to verify whether vaccination with Dukoral® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor CNI) or mycophenolate mofetil (MMF).
详细描述
BACKGROUND:
LT-ETEC is the most common cause of travelers' diarrhoea. Dukoral® (SBL Vaccines) reduces the severity and duration of LT-ETEC induced diarrhea. Dehydration due to diarrhea poses a risk to the health of renal transplant recipients. Therefore Dukoral may benefit this group of travelers.
AIM OF THIS STUDY:
Primary objective: To verify whether vaccination with Dukoral® (SBL Vaccines) induces an immune response in renal transplant recipients on prednisolone in combination with either a calcineurin inhibitor (cyclosporine or tacrolimus) or mycophenolate mofetil.
Secondary objective: To evaluate to what extent, the immune response differs, depending on the use of different classes of immunosuppressive drugs (CNI or MMF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •HEALTHY VOLUNTEERS
- •Inclusion criteria:
- •Above 18 years of age
- •Informed consent
排除标准
- •History of an auto-immune disease (SLE, ANCA associated vasculitis, Goodpasture, Henoch Schonlein, cryoglobulinemia, secondary vasculitis, polyarteritis nodosa and immunodeficiency disorders like IgA deficiency)
- •Chronic infection
- •Past vaccination with Dukoral or another cholera or ETEC vaccine
- •History of infection with Vibrio cholerae
- •Episode of diarrhoea in the 6 months prior to inclusion
- •Allergy to vaccine-specific components
- •History of a severe allergic reaction to any vaccine
- •Treatment with blood products in the 3 months prior to inclusion
- •Current pregnancy or breastfeeding
- •Premenopausal women not willing to use contraceptives during the first 60 days after vaccination
- •Use of any immunosuppressive drug
- •RENAL TRANSPLANT RECIPIENTS
- •Inclusion Criteria:
- •Above 18 years of age
- •Creatinin clearance ≥ 40 ml/min measured in the 6 months prior to inclusion
- •Stable renal function for 1 year prior to inclusion
- •Stable immunosuppressive regimen of a CNI, MMF or mTORi combined with prednisolone for at least 3 months prior to inclusion
- •Informed Consent
- •Exclusion Criteria:
- •History of an auto-immune disease (SLE, ANCA associated vasculitis, Goodpasture, Henoch Schonlein, cryoglobulinemia, secondary vasculitis, polyarteritis nodosa and immunodeficiency disorders like IgA deficiency)
- •Chronic infection
- •Treatment for rejection of the transplant in the past 1 year prior to inclusion
- •Past vaccination with Dukoral or another cholera or ETEC vaccine
- •History of infection with Vibrio cholerae
- •Episode of diarrhoea in the 6 months prior to inclusion
- •Allergy to vaccine-specific components
- •History of a severe allergic reaction to any vaccine
- •Treatment with blood products in the 3 months prior to inclusion
- •Current pregnancy or breastfeeding
- •Premenopausal women not willing to use contraceptives during the first 60 days after vaccination
- •Use of an immunosuppressive drug other than CNI, MMF, mTORi or prednisolone at the the time of inclusion
结局指标
主要结局
Percentage seroconversion among all renal transplant recipients.
时间窗: day 20-22
≥3-fold rise in serum anti-CTB antibodies or ≥4-fold rise in serum vibriocidal antibodies.
次要结局
- Group differences in geometric mean antibody titers after vaccination(day 20-22)
研究者
Darius Soonawala
Drs
Leiden University Medical Center