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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00106964
First Posted: April 4, 2005
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Results First Submitted: October 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This is a multi-site study. Accrual was open between April 2006 and January 2008. Participants were enrolled in the United States, South Africa, Brazil, and the Bahamas.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized into one of three arms using blocks of six and stratified by absolute CD4 count (less than 500 and 500 cells/mL or greater) and previous hepatitis B virus (HBV) vaccination (0,1). The randomization was restricted so that the percentage of subjects with CD4 count < = 200 cells/mL would not exceed 15% of subjects on any arm.

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.

Participant Flow:   Overall Study
    1: Engerix 20 mcg   2: Engerix 40 mcg   3: Twinrix 20 mcg
STARTED   118   126   127 
COMPLETED   105 [1]   111 [2]   120 [3] 
NOT COMPLETED   13   15   7 
Lost to Follow-up                8                6                2 
Pregnancy                2                3                2 
Death                1                1                0 
Incarceration                0                1                0 
Site Funding Terminated                0                1                1 
Failure to adhere                2                0                0 
Did not meet eligibility criteria                0                2                2 
Required disallowed medication                0                1                0 
[1] The number of those those who completed the vaccine series was 105.
[2] The number of those who completed the vaccine series was 111.
[3] The number of those who completed the vaccine series was 120.



  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.
No text entered.

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
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Time Frame Data were collected over a three year time period.
Additional Description There were no Serious Adverse Events (SAE) to report

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    1: Engerix 20 mcg   2: Engerix 40 mcg   3. Twinrix 20 mcg
Total, Other (not including serious) Adverse Events       
# participants affected / at risk   28/118 (23.73%)   25/126 (19.84%)   25/127 (19.69%) 
Blood and lymphatic system disorders       
Blood and lymphatic System Disorders †       
# participants affected / at risk   7/118 (5.93%)   5/126 (3.97%)   6/127 (4.72%) 
# events   7   5   6 
Gastrointestinal disorders       
Gastrointestinal Disorders †       
# participants affected / at risk   4/118 (3.39%)   11/126 (8.73%)   1/127 (0.79%) 
# events   4   11   1 
General disorders       
General Disorders and Administration Site Conditions †       
# participants affected / at risk   14/118 (11.86%)   3/126 (2.38%)   7/127 (5.51%) 
# events   14   3   7 
Infections and infestations       
Infecions and Infestations †       
# participants affected / at risk   14/118 (11.86%)   12/126 (9.52%)   7/127 (5.51%) 
# events   14   12   7 
Investigations       
Investigations †       
# participants affected / at risk   12/118 (10.17%)   5/126 (3.97%)   9/127 (7.09%) 
# events   12   5   9 
Nervous system disorders       
Nervous System Disorders †       
# participants affected / at risk   17/118 (14.41%)   14/126 (11.11%)   12/127 (9.45%) 
# events   17   14   12 
Events were collected by systematic assessment



  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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  More Information



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