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Comparison of Three Hepatitis B Vaccination Regimens in HIV-Positive Youth

2017年2月27日 更新者：University of North Carolina, Chapel Hill

A Randomized, Open-Label Trial of Three Hepatitis B Vaccination Schemas in HIV-Positive Youth

Hepatitis B is a contagious virus that can damage a person's liver. It can be prevented by vaccination, but for many HIV-positive people, the vaccines do not help them achieve adequate protection against this virus. In an attempt to improve response to vaccination and achieve protection from hepatitis B, this trial will compare the immune system response to 3 hepatitis B vaccine regimens in HIV-positive adolescents 12 through 24 years of age.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Suboptimal response to hepatitis B vaccination in HIV+ adults and children has been well documented in the literature. Given the importance of preventing hepatitis B virus (HBV) co-infection in HIV+ youth and the poor response rates in this population, this study will attempt to improve the immediate and long-term sero-response rates by undertaking a randomized, open-label trial of three hepatitis B vaccination schemas, as follows:

  1. standard adult dosing of HBV-only vaccine: Engerix-B 20 mcg at Entry, Week 4 and Week 24
  2. increased adult dosing of HBV-only vaccine: Engerix-B 40 mcg at Entry, Week 4 and Week 24
  3. standard adult dosing of combined HBV/hepatitis A virus (HAV) vaccine: Twinrix 720 enzyme immunoassay (EIA) HAV Ag plus 20 mcg HBsAg at Entry, Week 4 and Week 24.

This study will also describe the safety of administration of an increased dose of the hepatitis B vaccine in this population. In general, patients undergoing dialysis who have received the dosing regimen recommended for immunocompromised individuals have tolerated the vaccine series well.

Design: This is a stratified, block-randomized, open-label trial of three hepatitis B vaccination schemas in HIV-infected and HBV-uninfected youth. Once randomized, there will be a total of 6 study visits in a 72 week period. Vaccination will occur at Entry, Week 4 and Week 24. Primary sero-response will be evaluated at Week 28 and sustainability of response will be evaluated at Weeks 48 and 72 for those who achieve a primary antibody response of >= 10 IU/ml. Primary non-responders (antibody response of < 10 IU/ml) will be provided with a booster vaccine using the increased-dose Engerix-B vaccine at Week 48 and evaluated for responsiveness at Week 72.

研究类型

介入性

注册 (实际的)

371

阶段

  • 第四阶段

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

  • 南非
    • Cape Town
      • Bellville、Cape Town、南非、7505
        • Tygerberg Hospital
    • Gauteng
      • Johannesburg、Gauteng、南非、2013
        • Harriet Shezi Childrens Clinic Chris Hani Baragwanth Hospital
  • 巴西
      • Rio de Janeiro、巴西、20221-903
        • Hospital dos Sevidores do Estado
      • Rio de Janeiro、巴西、21941590
        • Ippmg-Ufrj
    • MG
      • Belo Horizonte、MG、巴西、30130-100
        • Federal University of Minas Gerais
    • SP
      • Ribeirao Preto、SP、巴西、14049-900
        • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto/USP
      • Sao Paulo、SP、巴西、01246-900
        • Instituto de Infectologia Emilio Ribas
  • 美国
    • California
      • Los Angeles、California、美国、90054
        • Childrens Hosp of Los Angeles
      • San Fransisco、California、美国、94118
        • University of California at San Francisco
    • District of Columbia
      • Washington、District of Columbia、美国、20010
        • Children's Hosp Natinal Med Center
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • Tulane Med Center

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

12年 至 24年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Documented HIV+
  • Age 12 to < 25 years
  • History of no or one hepatitis B vaccination
  • Not pregnant.
  • Females engaging in sexual intercourse must be willing to practice an approved method of birth control throughout the completion of the vaccine phase of the study.

Exclusion Criteria:

  • History of > 1 hepatitis B vaccination
  • Serologic evidence of past or present hepatitis B infection: anti-hepatitis B surface antigen (HBsAg), HBs-Ag or anti- hepatitis B core antigen (HBcAg)
  • Previous allergic reaction to hepatitis A or B vaccinations or to yeast, thimerosal or aluminum.
  • Active opportunistic infection or current treatment for known or suspected active serious bacterial infection at the pre-entry exam.

Presence of any known grade >= 3 clinical or laboratory toxicity at the time of pre-entry per toxicity tables.

  • Anticipation of long-term corticosteroid therapy or within 3 months preceding study randomization. Use of non-steroidal, anti-inflammatory agents and inhaled or topical corticosteroids are allowed.
  • Receipt of any restricted medicine listed in the protocol section 8.1.3 within 3 months preceding randomization.
  • Receipt of immune globulin product or plasma product within 6 months preceding randomization
  • Receipt of licensed blood product or transfusion or any licensed vaccine within 4 weeks preceding randomization.
  • Known or suspected diseases of the immune system, other than HIV, or treatment for a malignancy within 3 months of randomization.
  • Other serious, acute or chronic medical or surgical conditions must be approved by the protocol chair.

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：1
Standard dose (20 mcg) of Hepatitis B vaccine.
生物：Engerix-B 20 mcg
A single dose of 1 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Weeks 4 and 24.
有源比较器：2
40 mcg of Hepatitis B vaccine
生物：Engerix-B 40 mcg
A single dose of 2 mL (20 mcg/mL) will be administered in the deltoid muscle at Entry, Week 4 and 24.
有源比较器：3
20 mgc of Twinrix
生物：Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg

Arm 3: 720 EIA HAV Ag, 20 mcg HBsAg/ml:

A single dose of 1 mL will be administered in the deltoid muscle.

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
Sero-response to Hepatitis B Surface Antigen
大体时间：Week 28
The primary outcome, percentage positive sero-response, was compared between Arm 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) and measured 4 weeks after the third vaccination at Week 28. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.
Week 28

次要结果测量

结果测量
措施说明
大体时间
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED
大体时间：Baseline through Week 72
The number of adverse events (AE) was described by study arm. The proportion of subjects with clinical adverse events in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in patients with any grade toxicity.
Baseline through Week 72
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED
大体时间：Baseline through Week 72
The number of AEs was described by study arm. The proportion of subjects with clinical AEs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3)were compared to assess whether or not there is a difference in subjects with any grade toxicity.
Baseline through Week 72
Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY
大体时间：Baseline through Week 72
The number of adverse events and subjects with the events were described by study arm. The proportion of subjects with abnormal labs in Arms 1 and each of the two alternative strategy arms (Arm 2 and Arm 3) were compared to assess whether or not there is a difference in subjects with grade 3 or 4 toxicity. The laboratory events included are AEs classified as probably, possibly, or definitely related to study drug as classified by the Site Investigator.
Baseline through Week 72
Response Rates in HIV+ Youth Within Each Study Arm by Study Duration
大体时间：Entry through Week 72
Within each arm, the duration of response in HIV-infected youth was analyzed for all subjects who were responders at 28 weeks. The possible values for response duration could be 20 weeks or less (responder at 28 weeks but not at 48 weeks), 20 to 44 weeks (responder at 28 and 48 weeks but not at 72 weeks), or greater than 44 weeks (responder at 28, 48, and 72 weeks). A response of greater than 20 weeks includes those who responded after 20 weeks, but whose exact response duration was unknown.
Entry through Week 72
Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM
大体时间：Week 28
Response rate associated with the participant's study arm, baseline CD4 count, and interaction term that reflects how subjects in Arm 2 responded differently depending on their CD4 count. Response is defined as greater than or equal to 10 IU/mL of serum being present; non-response is defined as less than 10 IU/mL.
Week 28

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。

赞助

University of North Carolina, Chapel Hill

合作者

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)

调查人员

  • 首席研究员：Patricia Emmanuel, MD、University of South Florida, Peds. Div. of Infectious Disease
  • 首席研究员：Diane M. Straub, MD、University of South Florida, Peds. Div. of Infectious Disease
  • 首席研究员：Jorge Lujuan-Ziberman, MD、University of South Florida, Peds. Div. of Infectious Disease
  • 首席研究员：Lawrence D'Angelo, MD、Children's National Medical Center, Div. of Aldol & Young Adult Medicine
  • 首席研究员：Carleen Townsend-Akpan, CPNP、Children's National Medical Center, Div. of Aldol & Young Adult Medicine
  • 首席研究员：Jaime Martinez, MD、John H. Stroger Jr. Hospital
  • 首席研究员：Lisa Henry- Reid, MD、John H. Stroger Jr. Hospital
  • 首席研究员：Irma Febo, MD、University Pediatric Hospital
  • 首席研究员：LLeana Blasini, MD、University Pediatric Hospital
  • 首席研究员：Donna Futterman, MD、Montefiore Medical Center
  • 首席研究员：Marina Catallozzi, MD、Montifiore Medical Center
  • 首席研究员：Linda Levin, MD、Icahn School of Medicine at Mount Sinai
  • 首席研究员：Barbara Moscicki, MD、Univ. of California at San Franciso
  • 首席研究员：Coco Auerswald, MD、Univ. of California at San Franciso
  • 首席研究员：Sue Ellen Abdalian, MD、Tulane Medical Center
  • 首席研究员：Ligia Peralta, MD、University of Maryland
  • 首席研究员：Lawrence Friedman, MD、University of Miami
  • 首席研究员：Ana Puga, MD、Children's Diagnostic & Treatment Center
  • 首席研究员：Stephen Spector, MD、University of California, San Diego
  • 首席研究员：Rolando M Viani, MD、University of California, San Diego

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

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

2004年1月1日

初级完成 (实际的)

2008年1月1日

研究完成 (实际的)

2009年6月1日

研究注册日期

首次提交

2005年4月1日

首先提交符合 QC 标准的

2005年4月1日

首次发布 (估计)

2005年4月4日

研究记录更新

最后更新发布 (实际的)

2017年3月29日

上次提交的符合 QC 标准的更新

2017年2月27日

最后验证

2016年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • ATN 024

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.

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