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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00106964
First received: April 1, 2005
Last updated: June 23, 2014
Last verified: April 2014
Results First Received: October 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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


  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  
Number of Participants  
[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  
Gender  
[units: participants]
       
Female     73     74     80     227  
Male     45     52     47     144  
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
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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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