Safety and Effectiveness of PENNVAX-B Vaccine Alone, With Il-12, or IL-15 in Healthy Adults
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of PENNVAX-B (Gag, Pol, Env) Given Alone, With IL-12 DNA, or With a Dose Escalation of IL-15 DNA, in Healthy, HIV-1-uninfected Adults Participants
研究概览
详细说明
A vaccine that is effective against multiple strains of HIV remains the best option for preventing the spread of HIV. Plasmid DNA vaccines are inexpensive and easy to construct. When DNA vaccines are administered in combination with cytokines, such as IL-12 or IL-15, the immune response to the vaccine is increased. The purpose of this study is to determine the safety and tolerability of the DNA plasmid vaccine, PENNVAX-B when administered alone, or with IL-12 or IL-15 DNA adjuvants. The most effective and safe dose of IL-15 will also be determined during this study.
This study will last approximately 12 months. Participants will be randomly assigned to one of four groups. Group 1 will receive an injection of PENNVAX-B combined with 0.8 mg IL-15 in each deltoid or placebo. Group 2 will receive an injection of PENNVAX-B alone or placebo. Group 3 will receive an injection of PENNVAX-B combined with IL-12 in each deltoid or placebo. Group 4 will receive PENNVAX-B combined with 2 mg IL-15 or placebo. Injections will occur at study entry, Months 1, 3, and 6. Additional study visits will occur on Days 14, 42, 98, 182, 273, and 364. At these visits a brief physical, blood collection, interview, and risk reduction counseling will occur. At some visits HIV testing, urine collection, and pregnancy tests will also occur.
As of 05/30/08, participants will be enrolled into Groups 3 and 4 at a limited pace to allow for additional safety reviews for the first few participants in these groups. Additionally, safety data will be reviewed for Groups 1 and 2 to determine whether the remainder of participants in Groups 2, 3, and 4 will be enrolled.
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
-
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Alabama
-
Birmingham、Alabama、美国、35294
- Alabama Vaccine CRS
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California
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San Francisco、California、美国
- San Francisco Vaccine and Prevention CRS
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Massachusetts
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Boston、Massachusetts、美国
- Brigham and Women's Hosp. CRS
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New York
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Bronx、New York、美国、10456
- NY Blood Ctr./Bronx CRS
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New York、New York、美国、10003
- NY Blood Ctr./Union Square CRS
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New York、New York、美国、10032
- HIV Prevention & Treatment CRS
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Pennsylvania
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Philadelphia、Pennsylvania、美国
- 3535 Market Street CRS
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Tennessee
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Nashville、Tennessee、美国
- Vanderbilt Vaccine CRS
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- HIV-1 and -2 uninfected
- Willing to receive HIV test results
- Good general health
- Certain laboratory values within normal range or with site physician approval
- Negative for Hepatitis B surface antigen
- Negative Hepatitis C test
- Willing to use acceptable methods of contraception
Exclusion Criteria:
- HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
- Immunosuppressive medications within 168 days prior to first study vaccination. Participants using corticosteroid nasal spray for allergies or topical corticosteroids for mild, uncomplicated dermatitis are not excluded.
- Blood products within 120 days prior to first study vaccination
- Receipt of immunoglobulin within 60 days prior to first vaccination
- Live attenuated vaccines within 30 days prior to first study vaccination
- Any vaccine that is not a live attenuated vaccine within 14 days prior to first study vaccination
- Investigational research agents within 60 days prior to first study vaccination
- Current anti-tuberculosis (TB) preventive therapy or treatment clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
- Any medical, psychiatric, social, occupational, or other condition or responsibility that in the opinion of the investigator would interfere with the study. More information about this criterion can be found in the protocol.
- Allergy to amide-type local anesthetics
- Serious adverse reactions to vaccines
- Autoimmune disease or immunodeficiency
- Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
- Asthma other than mild, well-controlled asthma. More information on this criterion can be found in the protocol.
- Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
- Thyroidectomy or thyroid disease requiring medication during the 12 months prior to study entry
- Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry if episodes are considered serious or have required medication in the 2 years prior to study entry
- Uncontrolled hypertension
- Body Mass Index of 40 or greater OR of 35 or greater if certain other criteria apply. More information about these criteria can be found in the protocol
- Bleeding disorder
- Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
- Seizure disorder
- Absence of the spleen
- Pregnancy or breastfeeding
学习计划
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：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1
PENNVAX-B with 0.8 mg IL-15 administered in both deltoids at Months 0, 1, 3, and 6
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DNA vaccine containing the HIV genes Gag, Pol, and Env
Cytokine injection
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|
实验性的：2
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
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DNA vaccine containing the HIV genes Gag, Pol, and Env
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实验性的：3
PENNVAX-B administered alone in both deltoids at Months 0, 1, 3, and 6
|
DNA vaccine containing the HIV genes Gag, Pol, and Env
Cytokine injection
|
|
实验性的：4
PENNVAX-B with 2 mg IL-15 injected into both deltoids at Months 0, 1, 3, and 6
|
DNA vaccine containing the HIV genes Gag, Pol, and Env
Cytokine injection
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Safety data including local and systemic reactogenicity sign and symptoms, laboratory measures of safety, and adverse and serious adverse events
大体时间：Throughout study
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Throughout study
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Safety data from Groups 1 and 4
大体时间：Throughout study
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Throughout study
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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HIV-1 specific interferon gamma ELISpot and/or intracellular cytokine staining T cell response
大体时间：2 weeks after 3rd and 4th vaccinations
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2 weeks after 3rd and 4th vaccinations
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HIV-1 specific neutralizing and binding antibody assays
大体时间：2 weeks after 3rd and 4th vaccinations
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2 weeks after 3rd and 4th vaccinations
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合作者和调查者
调查人员
- 学习椅：Scott Parker, MD、HVTN, FHCRC
出版物和有用的链接
一般刊物
- Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
- Johnston MI, Fauci AS. An HIV vaccine--evolving concepts. N Engl J Med. 2007 May 17;356(20):2073-81. doi: 10.1056/NEJMra066267. No abstract available.
- Ogawa H, Ueno M, Uchibori H, Matsumoto I, Seno N. Direct carbohydrate analysis of glycoproteins electroblotted onto polyvinylidene difluoride membrane from sodium dodecyl sulfate-polyacrylamide gel. Anal Biochem. 1990 Nov 1;190(2):165-9. doi: 10.1016/0003-2697(90)90175-9.
- McBurney SP, Ross TM. Developing broadly reactive HIV-1/AIDS vaccines: a review of polyvalent and centralized HIV-1 vaccines. Curr Pharm Des. 2007;13(19):1957-64. doi: 10.2174/138161207781039841.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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