Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths

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:
NCT00107042
First received: April 4, 2005
Last updated: June 23, 2014
Last verified: April 2014
Results First Received: September 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Hepatitis B
Interventions: Biological: Recombivax
Biological: Twinrix

  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
The study was started in February 2004 and was completed in July 2008. A total of 11 sites, all in the United States and Puerto Rico, participated in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24

Participant Flow:   Overall Study
    Recombivax     Twinrix  
STARTED     60     63  
COMPLETED     38     47  
NOT COMPLETED     22     16  
Lost to Follow-up                 9                 7  
Withdrawal by Subject                 6                 1  
Moved out of area                 5                 3  
Pregnancy                 1                 1  
Inadvertent enrollment                 0                 1  
vaccinated outside window                 1                 1  
Disallowed medications                 0                 2  



  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
Recombivax Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
Twinrix Experimental: 1st dose at Week 0, 2nd dose at Week 24
Total Total of all reporting groups

Baseline Measures
    Recombivax     Twinrix     Total  
Number of Participants  
[units: participants]
  60     63     123  
Age  
[units: years]
Mean ± Standard Deviation
  15.02  ± 1.43     15.22  ± 1.71     15.12  ± 1.58  
Age, Customized  
[units: participants]
     
12 - 14 years     18     23     41  
15 - 17 years     42     40     82  
Gender  
[units: participants]
     
Female     19     27     46  
Male     41     36     77  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     20     14     34  
White     3     6     9  
More than one race     37     43     80  
Unknown or Not Reported     0     0     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Qualitative Seroresponsiveness to Hepatitis B Surface Antigen   [ Time Frame: Week (Wk) 28 (One month after the second immunization) ]

2.  Primary:   Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))   [ Time Frame: Week 12, Week 24, Week 28, Week 76 ]

3.  Primary:   Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)   [ Time Frame: Week 12, Week 24, Week 28, Week 76 ]

4.  Secondary:   Quantitative Vaccine Response   [ Time Frame: Week 28 ]

5.  Secondary:   Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.   [ Time Frame: Week 28 ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Measure Description The Log10 titer at Week 28 was used as the quantitative continuous vaccine response.
Time Frame Week 28  
Safety Issue No  

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.
The data for this analysis included those who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (as treated population).

Reporting Groups
  Description
All Participants All participants who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (per protocol). Participants were vaccinated at Week 0 and Week 24 with either Recombivax or Twinrix.

Measured Values
    All Participants  
Number of Participants Analyzed  
[units: participants]
  75  
Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.  
[units: Participant]
 
Study Arm: Recombivax     34  
Study Arm: Twinrix     41  
Site Effect: Other Site     43  
Site Effect: Baltimore     32  
Age: 15 - 17 years     51  
Age: 12 - 14 years     24  
Gender: Female     29  
Gender: Male     46  
Hispanic Ethnicity: No     23  
Hispanic Ethnicity: Yes     52  
Racial Background: White     6  
Racial Background: Other/Mixed Race     47  
Racial Background: Black/African American     22  
Tanner Stage for Females: Stage 5     17  
Tanner Stage for Females: Stages 1 - 4     12  
Tanner Stage for Males: Stage 5     15  
Tanner Stage for Males: Stages 1 - 4     31  
BMI at Baseline: Normal and Underweight (<25.0)     49  
BMI at Baseline: Overweight and Obese (>=25.0)     26  
Ever Smoked Cigarettes: No     59  
Ever Smoked Cigarettes: Yes     16  
Sexual Identity: Straight (Heterosexual)     67  
Sexual Identity: Gay, Bi, Not Sure or Undecided     8  
Age First Sex Not Forced: Never     44  
Age First Sex Not Forced: <=14 Years     8  
Age First Sex Not Forced: 15-17 Years     17  
Total Lifetime Sex Partners: 0 Partners     44  
Total Lifetime Sex Partners: 1-5 Partners     19  
Total Lifetime Sex Partners: >= 6 Partners     10  
Total Lifetime Male Sex Partners: 0 Partners     58  
Total Lifetime Male Sex Partners: 1-5 Partners     10  
Total Lifetime Male Sex Partners: >= 6 Partners     5  
Total Lifetime Female Sex Partners: 0 Partners     57  
Total Lifetime Female Sex Partners: 1-5 Partners     11  
Total Lifetime Female Sex Partners: >= 6 Partners     5  
Ever Drank Alcohol: No     45  
Ever Drank Alcohol: Yes     30  
Ever Smoked Marijuana: No     58  
Ever Smoked Marijuana: Yes     17  
Ever Used Drugs not Prescribed: No     71  
Ever Used Drugs not Prescribed: Yes     4  


Statistical Analysis 1 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.1667
Regression coefficient [4] 0.2455
Standard Error of the mean ± 0.1757
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of treatment arm (Recombivax vs. Twinrix) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.9890
Regression coefficent [4] -0.0025
Standard Error of the mean ± 0.1792
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of site effect(Other sites vs. Baltimore) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 3 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.2796
Regression coeffcient [4] 0.2053
Standard Error of the mean ± 0.1885
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of age(15 - 17 year old particpants vs. 12 - 14 year old participants) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 4 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0080
Regresssion coeffcient [4] -0.4726
Standard Error of the mean ± 0.1734
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of gender(Females vs. Males) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 5 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.2543
Regression coefficient [4] 0.2189
Standard Error of the mean ± 0.1905
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Hispanic ethnicity (Not Hispanic vs. Hispanic) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 6 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.3661
Regression coefficient [4] 0.2994
Standard Error of the mean ± 0.3292
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Other/Mixed Race is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 7 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.9812
Regression coefficient [4] 0.0083
Standard Error of the mean ± 0.3497
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of racial background(White vs. Other/Mixed vs. Black/African American) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between White vs. Black/African American is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 8 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.7766
Regression coefficient [4] -0.0663
Standard Error of the mean ± 0.2314
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Tanner Stage for Females(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 9 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.2492
Regression coefficient [4] -0.2929
Standard Error of the mean ± 0.2508
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Tanner Stage for Males(Stage 5 vs. Stages 1 - 4) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 10 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0877
Regression coeffcient [4] -0.3160
Standard Error of the mean ± 0.1826
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of BMI at Baseline(Normal and Underweight (<25.0) vs. Overweight and Obsese (>= 25.0)) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 11 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0117
Regression coefficient [4] -0.0292
Standard Error of the mean ± 0.0113
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of BMI at Baseline(continuous variable) on vaccine response as measured in log10 titers.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 12 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.7899
Regression coefficient [4] -0.0578
Standard Error of the mean ± 0.2163
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of smokng cigarettes(Never Smoked vs. Has Smoked) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 13 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0607
Regression coefficient [4] -0.5339
Standard Error of the mean ± 0.2803
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of sexual identity(Straight (heterosexual) vs. Gay (homosexual), Bi (bisexual), and Not Sure or Undecided) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 14 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.1670
Regression coefficient [4] -0.3883
Standard Error of the mean ± 0.2779
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of age at which the subject first had unforced sex (Never vs. <= 14 year olds vs. 15-17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between "never" vs. "<= 14 year olds" is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 15 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.8682
Regression coefficient [4] 0.0344
Standard Error of the mean ± 0.2065
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of age at which subject had first unforced sex (Never vs. <= 14 year olds vs. 15 - 17 year olds) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between "never" vs. "15-17 year olds" is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 16 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.4219
Regression coefficient [4] 0.1532
Standard Error of the mean ± 0.1896
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of total number of lifetime sex partners (0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 17 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0020
Regression coefficient [4] -0.7752
Standard Error of the mean ± 0.2420
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Total Number of Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 18 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.1659
Regression coefficient [4] 0.2921
Standard Error of the mean ± 0.2086
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 19 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0000
Regression coefficient [4] -1.6163
Standard Error of the mean ± 0.2839
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Total Number of Male Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 20 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.4701
Regression coefficient [4] -0.1788
Standard Error of the mean ± 0.2463
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. 1-5 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 21 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.7572
Regression coefficient [4] 0.1083
Standard Error of the mean ± 0.3488
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of Total Number of Female Lifetime Sex Partners(0 partners vs. 1-5 partners vs. >= 6 partners) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups. In this statistical analysis, information for the comparison between 0 partners vs. >= 6 partners is presented.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 22 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.8657
Regression coefficient [4] -0.0307
Standard Error of the mean ± 0.1809
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of whether a subject ever drank alcohol (No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 23 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.0917
Regression coefficient [4] -0.3548
Standard Error of the mean ± 0.2076
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of whether a subject ever smoked marijuana(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 24 for Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.
Groups [1] All Participants
Method [2] Regression, Linear
P Value [3] 0.3788
Regression coefficient [4] -0.3474
Standard Error of the mean ± 0.3924
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  This is a regression analysis for testing the effect of whether a subject ever used drugs not prescribed(No vs. Yes) on vaccine response as measured in log10 titers. The null hypothesis is no difference between groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



6.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.   [ Time Frame: Week 28 ]

7.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT   [ Time Frame: Week 28 ]

8.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE   [ Time Frame: Week 28 ]

9.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: GENDER   [ Time Frame: Week 28 ]

10.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: HISPANIC ETHNICITY   [ Time Frame: Week 28 ]

11.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: RACE   [ Time Frame: Week 28 ]

12.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR FEMALES   [ Time Frame: Week 28 ]

13.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TANNER STAGE FOR MALES   [ Time Frame: Week 28 ]

14.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: BMI at Baseline   [ Time Frame: Week 28 ]

15.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED CIGARETTES   [ Time Frame: Week 28 ]

16.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SEXUAL IDENTITY   [ Time Frame: Week 28 ]

17.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE AT WHICH SUBJECT FIRST HAD SEX (NOT FORCED)   [ Time Frame: Week 28 ]

18.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS   [ Time Frame: Week 28 ]

19.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME MALE SEX PARTNERS   [ Time Frame: Week 28 ]

20.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME FEMALE SEX PARTNERS   [ Time Frame: Week 28 ]

21.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER DRANK ALCOHOL   [ Time Frame: Week 28 ]

22.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER SMOKED MARIJUANA   [ Time Frame: Week 28 ]

23.  Secondary:   Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: EVER USED DRUGS NOT PRESCRIBE   [ Time Frame: Week 28 ]

24.  Secondary:   Immunogenicity to Hep B 18 Months After First Immunization   [ Time Frame: Week 76 ]

25.  Secondary:   Immunogenicity to Hep A in the Twinrix Arm: One Month Post 2nd Vaccination   [ Time Frame: Week 28 ]

26.  Secondary:   Immunogenicity to Hep A in Twinrix Arm: Twelve Months Post 2nd Vaccination   [ Time Frame: Week 76 ]

27.  Secondary:   Immunogenicity to Hep A in Twinrix Arm: Overall Response (1-month or 12-month After 2nd Vaccination)   [ Time Frame: Week 28 and Week 76 ]

28.  Secondary:   As Treated Analysis – Adequate Antibody Response to Hep B Surface Antigen   [ Time Frame: Week 28 ]

29.  Secondary:   Assessment of Youth Understanding of Vaccine Trial and Informed Consent   [ Time Frame: Screening ]


  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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