Safety and Immunogenicity of Recombinant Glycoprotein E Herpes Zoster Subunit (HZ/su) Vaccine in Renal Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Change in levels of Anti-gE antibody concentrations
研究概览
简要总结
This study will assess the immune responses to the recombinant, AS01-adjuvanted varicella zoster virus subunit (HZ/su) vaccine or SHINGRIX in immunosuppressed patients, particularly those who have received a renal transplant, and aim to better understand if the vaccine and perhaps other adjuvanted vaccines are safe in these patients.
30 participants will be divided into 2 groups, one group will receive the 1st out of 2 doses of the vaccine 3-6 months after transplant per standard of care and the second group will receive the 1st out of 2 doses of the vaccine 12-36 months after the transplant per standard of care.The duration of the study is 180 days.
详细描述
Shingles is a viral illness caused by the same virus that causes the chicken pox. Reactivation of this virus leads to shingles which is a painful blistering rash. Around 10% of organ transplant patients get shingles. This study will help us assess the safety and efficacy of a new shingles vaccine, SHINGRIX in Kidney Transplant patients. SHINGRIX is FDA approved for the prevention of shingles.
In this study, participants will be divided into 2 groups, one group will receive the 1st out of 2 doses of the vaccine 3-6 months after transplant per standard of care and the second group will receive the 1st out of 2 doses of the vaccine 12-36 months after the transplant per standard of care.
This research is conducted at the Emory University Hospital and Emory Clinics. Additionally follow up visits might also be conducted at the Emory Hope Clinic, the clinical arm of the Emory Vaccine Center.
Subjects will be identified through review of medical records or by referral from their healthcare providers. Subjects may also self-refer from the IRB approved recruitment flyers. Following identification/referral, a coordinator or recruiter will contact the subject and tell them about the study and see if he/she is interested. If the potential subject is interested, the recruiter will obtain an oral consent and prescreen them for the study using a screening checklist. Qualified subjects will be scheduled to come into the clinic and be fully consented and proceed with screening/enrollment.
Blood specimens will be collected and stored for the research study and for future use. Subjects can opt to have their information stored in a Hope Clinic database in order to contact them for other studies they may qualify for in the future. There are no other optional studies planned at this time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of informed consent and provision of written informed consent before any study procedures.
- •Capable of attending study visits according to the study schedule
- •Males or females greater than or equal to 50 years of age.
- •Oral temperature less than 38 C.
- •Are in general good health, as determined by medical history and targeted physical exam related to this history
- •Recent renal transplant (either 3-6 months or 12-36 months prior)
- •Have received maintenance immunosuppressive therapy for prevention of allograft rejection for a minimum of 30 days prior to the first vaccination
- •Have received an ABO compatible allogeneic renal transplant
- •Male subjects should agree not to contribute to conception of a child, including sperm donation, for the duration of the study.
排除标准
- •Have received any transplant in addition to renal transplant
- •Have an acute illness within 72 hours prior to vaccination
- •Have a severe medical condition as determined by the investigators
- •Have kidney disease related to any known immune/autoimmune phenomena including, but not limited to: systemic lupus erythematosus, glomerulonephritis (post-streptococcal, Goodpasture syndrome, granulomatosis with polyangitis, polyarteritis nodosa, etc.).
- •Be on systemic immunosuppressive agents aside from those related to their renal transplant
- •Have known HIV or primary immune deficiency
- •Have a known potential immune-mediated disorder (pIMD)
- •Have planned receipt of any unlicensed or investigational medications, biologics, or vaccines for the duration of subject study participation
- •Have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine
- •Have donated blood or blood products within 56 days before study vaccination and for the duration of the study
- •Have received the Shingrix or Zostavax injection previously
- •Have had Shingles in the past
- •Be of child-bearing potential
- •Have known recent exposure to wild-type varicella in the past 4 weeks
- •Have a history of severe reactions following other vaccinations
结局指标
主要结局
Change in levels of Anti-gE antibody concentrations
时间窗: Day 1, Day 61, Day 180
Anti-gE antibody concentrations will be obtained via enzyme-linked immunosorbent assay (ELISA)
Change in number of subjects with a vaccine response for anti-gE antibody
时间窗: Day 61, Day 180
Vaccine response is defined as: * For initially seronegative subjects, antibody concentration at post-vaccination greater than or equal to (≥) 4 fold the cut-off for Anti-gE (4x97 milli-international units per milliliter \[mIU/ml\]) * For initially seropositive subjects (defined as ≥ 97 mIU/ml), antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
次要结局
- Number of subjects with changes in allograft function(Day 180)
- Number of subjects with any related severe adverse events (SAEs)(Day 180)
- Number of subjects with any grade 3 related adverse events (AEs)(Day 91)
- Number of subjects with renal allograft rejection(Day 180)
- Change in HLA antibody titers(Day 1, Day 15, Day 61, Day 75, Day 180)
研究者
Nadine Rouphael
Associate Professor
Emory University