EUCTR2017-002236-17-GB进行中（未招募）1 期
Pneumococcal Vaccination to Accelerate Immune Recovery in Sepsis Survivors: randomized placebo-controlled trial - The VACIRISS Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 214
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Male or female adult patients aged 18 years or older on the date of screening for the trial
- •-Registered with a General practitioner
- •-Reason for admission to intensive care unit or high dependence unit was sepsis.
- •-Clinical condition has improved and the patient is ready for step down to HDU or ward based care in the next 24 – 48 hours
- •-Provision of written informed consent by the patient OR by patient’s Legal Representative OR Professional Consultee
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 214
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 214
排除标准
- •-Core temperature =38.0°C within the past 24 hours prior to study IMP administration. As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.
- •-Hypersensitivity reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine.
- •-Recent vaccination defined as any vaccination administered to subjects within 7 days of enrolment.
- •-Pregnant and lactating women.
- •-Limitations of care set including not for resuscitation, not for readmission to critical care.
- •-Residence in a nursing home, long-term care facility, or other institution, or requirement of semiskilled nursing care. (An ambulatory subject who was a resident of a retirement home or village is eligible for the trial.)
- •-As the IMP is administered intra muscularly, coagulopathy defined as platelet count less than 50 x 109/L and/or INR greater than 1.3. For this exclusion criteria bloods taken within 72 hours of screening are valid. If these standard of care blood results are not available, then these should form part of the screening bloods for assessing eligibility.
- •-Splenectomy (previous or in the current admission)
- •-Diagnosis of pneumococcal sepsis in the current admission
- •-APACHE II score defined Immune deficiency or suppression, defined as presence of 1 or more of the following conditions:
- •-Documented human immunodeficiency virus (HIV) infection at any time-point pre-trial. If previous results are not available and/or current admission is not due to HIV infection, these patients do not need new testing and are considered eligible for the trial.
- •-leukaemia (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
- •-lymphoma (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
- •-Hodgkin disease (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
- •-multiple myeloma (presence defined as having been treated by or been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
- •-malignancy (defined as presence of any malignancy that had been treated by or had been eligible for treatment by radiotherapy and/or chemotherapy within the last 5 years)
- •-chronic renal failure (defined as receipt of renal dialysis or transplant) or nephrotic syndrome
- •-receipt of immunosuppressive therapy, including steroids, within 3 months of study vaccine administration (For corticosteroids, prednisone or equivalent 0.5 mg/kg/day for 14 days or longer). Inhaled, intra- articular, and topical steroids are not considered immunosuppressive.
- •-Receipt of an organ or bone marrow transplant with ongoing immunosuppressive medications. Failed previous transplant patients not currently on immunosuppression are eligible.
研究者
相似试验
进行中（未招募）
1 期
Efficacité de la vaccination anti-pneumococcique en prime-boost chez les patients atteints de lymphome diffus à grandes cellules B traités par Rituximab en 1ère ligneEUCTR2019-002542-20-FRCHRU de TOURS36
已完成
4 期
Vaccination for immune recovery following sepsisInfection following recovery from sepsisInfections and InfestationsBacterial sepsisISRCTN11401066Guy's and St Thomas' NHS Foundation Trust214
尚未招募
不适用
Efficacy of pneumococcal conjugate vaccine in preventing acquisition and carriage of pneumococcal vaccine serotypes in Tanzanian children with human immunodeficiency virus/ acquired immunodeficiency syndrome (HIV/AIDS)Pneumococcal diseaseHIV/AIDSPublic Health - EpidemiologyInfection - Studies of infection and infectious agentsACTRN12610000999033Prof Robert Booy216
进行中（未招募）
不适用
Serological response to antipneumococcal vaccination and consequent impact on Streptococcus pneumoniae nasal carriage in HIV positive adultsHIV positive adults with out previous PPV23 or PCV7 vaccinationMedDRA version: 14.1Level: LLTClassification code 10035652Term: Pneumococcus infection in conditions classified elsewhere and of unspecified siteSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-004518-40-ITAZIENDA OSPEDALIERA SENESE
尚未招募
4 期
Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 YearsCOVID-19Pneumococcal InfectionsNCT05767606Medical University of Vienna256