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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00106964
First received: April 1, 2005
Last updated: February 27, 2017
Last verified: February 2016
Results First Received: October 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Prevention
Conditions: HIV Infection
Hepatitis B
Interventions: Biological: Engerix-B 20 mcg
Biological: Engerix-B 40 mcg
Biological: Twinrix 720 EIA HAV Ag plus 20 mcg HBsAg

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
1: Engerix 20 mcg Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
2: Engerix 40 mcg 40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
3: Twinrix 20 mcg 20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
Total Total of all reporting groups

Baseline Measures
   1: Engerix 20 mcg   2: Engerix 40 mcg   3: Twinrix 20 mcg   Total 
Overall Participants Analyzed 
[Units: Participants]
 118   126   127   371 
Age 
[Units: Years]
Mean (Standard Deviation)
 20.56  (3.42)   20.96  (3.25)   20.20  (3.50)   20.57  (3.40) 
Age, Customized 
[Units: Participants]
       
12-13 years   8   3   8   19 
14-15 years   5   11   10   26 
16-19 years   25   18   20   63 
>20 years   80   94   89   263 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      73  61.9%      74  58.7%      80  63.0%      227  61.2% 
Male      45  38.1%      52  41.3%      47  37.0%      144  38.8% 
Region of Enrollment 
[Units: Participants]
       
United States   52   54   49   155 
South Africa   4   6   13   23 
Brazil   52   58   58   168 
Bahamas   10   8   7   25 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Sero-response to Hepatitis B Surface Antigen   [ Time Frame: Week 28 ]

2.  Secondary:   Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - POSSIBLY OR PROBABLY RELATED   [ Time Frame: Baseline through Week 72 ]

3.  Secondary:   Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth - ADVERSE EVENTS BY INTERVENTION ARM ON STUDY - DEFINITELY RELATED   [ Time Frame: Baseline through Week 72 ]

4.  Secondary:   Safety of 3 Hepatitis B Vaccine Regimens in HIV+ Youth – ABNORMAL LABORATORY VALUES GRADE 2 OR ABOVE BY INTERVENTION ARM ON STUDY   [ Time Frame: Baseline through Week 72 ]

5.  Secondary:   Response Rates in HIV+ Youth Within Each Study Arm by Study Duration   [ Time Frame: Entry through Week 72 ]

6.  Secondary:   Sero-Response to Hepatitis B Surface Antigen; Predictor: STUDY ARM   [ Time Frame: Week 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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