NCT01195246已完成3 期
An Open-Label, Randomized, Multi-Center Study Comparing the Safety and Immunogenicity of HEPLISAV™ to Engerix-B® and Fendrix® in Adults on Hemodialysis Who Have Previously Received Hepatitis B Vaccination and Are Not Seroprotected
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 19
- 主要终点
- Proportion of subjects with seroprotection rate (SPR), defined as the percentage of subjects with anti-HBsAg serum concentration of 10 milli-international unit (mIU)/mL or higher, measured at Week 4
研究概览
简要总结
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on hemodialysis.
详细描述
The immune response of HEPLISAV compared with Engerix-B and Fendrix and measured by seroprotection rate (SPR) at 4 weeks after the booster injection
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Has loss of renal function and is receiving hemodialysis treatments
- •Is not seroprotected against hepatitis B (has anti-HBs < 10 mIU/mL)
- •In the opinion of the investigator, is clinically stable
- •Be serum negative for HBsAg, anti-hepatitis B core antigen (HBc), hepatitis C virus (HCV), and HIV
- •Is not scheduled to undergo a kidney transplant during the study period
- •If female, and of childbearing potential, subject must be: surgically sterile or neither pregnant nor breast-feeding, consistently using a highly effective method of birth control for at least one month prior to study entry, and agrees to use two forms of birth control consistently throughout the study.
排除标准
- •If female, is pregnant, breastfeeding, or planning a pregnancy;
- •Has a history of or is at high risk for recent exposure to HBV, HCV, or HIV;
- •Has known history of autoimmune disease;
- •Has history of sensitivity to any component of study vaccines;
- •Has a current condition other than renal disease or has substance or alcohol abuse that would interfere with compliance or with interpretation of the study results;
- •Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous or basal cell carcinoma of the skin;
- •Has uncontrolled diabetes;
- •Has received a kidney transplant previously that is still functioning and requires anti-rejection medication;
- •Has received any blood products or immunoglobulin within 3 months prior to study entry, or likely to require infusion of blood products during the study period;
- •Has received the following prior to the study injection: 3 days: intravenous iron; 21 days: any inactivated virus or bacterial vaccine; 28 days: any live virus or bacterial vaccine; systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids; granulocyte colony stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF); any other investigational medicinal agent;
- •At any time: an injection of deoxyribonucleic acid (DNA) plasmids or oligonucleotides; investigational or intradermal hepatitis B vaccine.
研究组 & 干预措施
Engerix-B
Active Comparator
2.0 mL Engerix-B
干预措施: Engerix-B (Biological)
HEPLISAV
Experimental
0.5 mL HEPLISAV
干预措施: HEPLISAV (Biological)
Fendrix
Active Comparator
0.5 mL Fendrix
干预措施: Fendrix (Biological)
结局指标
主要结局
Proportion of subjects with seroprotection rate (SPR), defined as the percentage of subjects with anti-HBsAg serum concentration of 10 milli-international unit (mIU)/mL or higher, measured at Week 4
时间窗: week 4
次要结局
- Overall incidence of post-injection reactions and adverse events in each treatment group(week 12)
研究者
研究点 (19)
Loading locations...
相似试验
已完成
2 期
Open-label, Non-randomized, Non-comparative, Phase II Study of Safety and Immunogenicity of Combination of AZD1222 and rAd26-S for COVID-19 PreventionCOVID-19NCT04686773R-Pharm100
已完成
3 期
Immunogenicity and Safety Study of LBVH0101 in Healthy Infants at Two, Four and Six Months of AgeInfectious Disease by Haemophilus Influenzae Type bNCT01019772LG Life Sciences217
已完成
2 期
Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19)COVID-19NCT04480424Grifols Therapeutics LLC100
已完成
3 期
A Study of Heterologous Vaccine Regimen of Adenovirus Serotype 26 Mosaic4 Human Immunodeficiency Virus(Ad26.Mos4.HIV), Adjuvanted Clade C gp140 and Mosaic gp140 to Prevent HIV-1 Infection Among Cis-gender Men and Transgender Individuals Who Have Sex With Cis-gender Men and/or Transgender IndividualsHealthyNCT03964415Janssen Vaccines & Prevention B.V.3,900
终止
3 期
A Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity, Safety of Quadrivalent HPV Recombinant Vaccine in Chinese Healthy FemalesGenital WartCIN1CIN2CIN3Vain IVain IIIVin IVin IIVin IIIVAIN - Vaginal Intraepithelial Neoplasia 2Cervical CancerAISNCT05584332Shanghai Bovax Biotechnology Co., Ltd.3,131