Safety, Tolerability and Immunogenicity Study of 2 Dose Levels of Trimeric Glycoprotein140 (gp140) in Healthy Adult Volunteers
2016年6月3日 更新者：Crucell Holland BV
A First in Human Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Dose Levels of Trimeric gp140 Protein in Healthy Adult Volunteers
The purpose of this study is to assess the safety and tolerability of 2 different dose levels of trimeric glycoprotein140 (gp140) administered as a 2-dosage regimen, intramuscularly (injection of a substance into a muscle), with and without aluminum phosphate as adjuvant in healthy human immunodeficiency virus (HIV)-uninfected participants.
研究概览
地位
完全的
条件
详细说明
This is a single-center, randomized (the study drug is assigned by chance), placebo-controlled (study in which the experimental treatment or procedure is compared to a pretend treatment with no drug in it to test if the drug has a real effect), and double-blind (neither physician nor participant knows the treatment that the participant receives) study.
The study comprises a Screening Period (up to 4 weeks), a Vaccination Period (participants will be vaccinated on Days 1 and 29), and a Follow-up Period (up to 48 weeks).
All eligible participants will be randomly assigned to 1 of the 2 sequential cohorts (low dose cohort and high dose cohort).
Participants in low dose cohort will receive 1 of the following treatments: low dose (50 microgram [mcg]) gp140 drug product (DP), low dose gp140 DP with adjuvant (aluminum phosphate), placebo matched to low dose DP; and participants in high dose cohort will receive 1 of the following treatments: high dose (250 mcg) gp140 DP, high dose gp140 DP with adjuvant, and placebo matched to high dose DP.
There will be an interim safety review of safety/tolerability from low-dose cohort before the high-dose cohort receives study treatment.
Total study duration will be 56 weeks per participant.
Participants' safety will be monitored throughout the study.
研究类型
介入性
注册 (实际的)
50
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
-
Miami、Florida、美国
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 50年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participant must be healthy on the basis of physical examination, medical history, electrocardiogram (ECG), laboratory criteria, and vital signs measurement performed at Screening
- Participants are negative for human immunodeficiency virus (HIV) infection at Screening (negative United States Food and Drug Administration-approved HIV diagnostic blood test)
- All female participants of childbearing potential must have a negative serum (beta human chorionic gonadotropin) at Screening, and a negative urine pregnancy test pre-dose on Day 1 and Day 29
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction until 3 months after receiving the last dose of study vaccine. A man must agree not to donate sperm until 3 months after receiving the last dose of study vaccine
- Participants are assessed by the clinic staff as being at low risk for HIV infection
Exclusion Criteria:
- Participant has chronic active hepatitis B or active hepatitis C, active syphilis infection, chlamydia, gonorrhea, or trichomonas. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
- In the 12 months prior to enrollment, participant has a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
- Participant has any clinically significant acute or chronic medical condition that in the opinion of the Investigator would preclude participation (for example, history of seizure disorders, bleeding/clotting disorder, autoimmune disease, active malignancy, poorly controlled asthma, active tuberculosis or other systemic infections)
- Participant has had major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study
- Participant has had a thyroidectomy, or thyroid disease requiring medication during the last 12 months
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：安慰剂 1
|
Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.
|
|
安慰剂比较：安慰剂 2
|
Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.
|
|
实验性的：gp140, 50 mcg
|
Glycoprotein 140 (gp140) vaccine containing 50 microgram (mcg) total protein will be administered intramuscularly on Day 1 and Day 29.
|
|
实验性的：gp140, 50 mcg + Adjuvant
|
The gp140 vaccine containing 50 mcg total protein mixed with 0.425 milligram (mg) aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.
|
|
实验性的：gp140, 250 mcg
|
The gp140 vaccine containing 250 mcg total protein will be administered intramuscularly on Day 1 and Day 29.
|
|
实验性的：gp140, 250 mcg + Adjuvant
|
The gp140 vaccine containing 250 mcg total protein mixed with 0.425 mg aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With Local and Systemic Reactogenicity Events Over 8 Days After First Vaccination
大体时间：Day 8
|
Participants will be asked to note occurrences of local reactions: erythema, induration, swelling, pain/tenderness, itching, or warmth at the injection site, and systemic events: daily temperature, fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching daily for 8 days post-vaccination.
These occurrences will be recorded through the memory aid provided to serve as a reminder to the participants for the next clinic visit.
|
Day 8
|
|
Number of Participants With Local and Systemic Reactogenicity Events Over 8 Days After Second Vaccination
大体时间：Day 36
|
Participants will be asked to note occurrences of local reactions: erythema, induration, swelling, pain/tenderness, itching, or warmth at the injection site, and systemic events: daily temperature, fatigue, headache, myalgia, arthralgia, chills, nausea, vomiting, rashes, and general itching daily for 8 days post-vaccination.
These occurrences will be recorded through the memory aid provided to serve as a reminder to the participants for the next clinic visit.
|
Day 36
|
|
Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
大体时间：Week 52 or early withdrawal
|
An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
Week 52 or early withdrawal
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Envelop (Env) Binding Antibody Titer at Week 8
大体时间：Week 8
|
The humoral immune response will be assessed by Env Clade C-specific enzyme-linked immunosorbent assay (ELISA) binding antibody titer at Week 8.
|
Week 8
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 研究主任：Crucell Holland BV Clinical Trials、Crucell Holland BV
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年12月1日
初级完成 (实际的)
2016年4月1日
研究完成 (实际的)
2016年4月1日
研究注册日期
首次提交
2014年11月26日
首先提交符合 QC 标准的
2014年11月26日
首次发布 (估计)
2014年12月1日
研究记录更新
最后更新发布 (估计)
2016年6月6日
上次提交的符合 QC 标准的更新
2016年6月3日
最后验证
2016年6月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- CR104488
- HIV-V-A003 (其他标识符：Crucell Holland BV)
- IPCAVD008 (其他标识符：Crucell Holland BV)
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
gp140, 50 mcg的临床试验
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH); Department of Health and Human Services招聘中
-
Sunovion Respiratory Development Inc.完全的
-
Janssen Vaccines & Prevention B.V.完全的
-
Janssen Vaccines & Prevention B.V.完全的
-
Radius Health, Inc.Nordic Bioscience A/S完全的
-
GlaxoSmithKline完全的
-
Janssen Vaccines & Prevention B.V.Beth Israel Deaconess Medical Center; US Military HIV Research Program; Ragon Institute of MGH...完全的
-
Janssen Vaccines & Prevention B.V.National Institute of Allergy and Infectious Diseases (NIAID); Beth Israel Deaconess Medical... 和其他合作者完全的健康美国, 南非, 泰国, 乌干达, 卢旺达