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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
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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
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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 ]

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 ]
  Hide Outcome Measure 8

Measure Type Secondary
Measure Title Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE
Measure Description Qualitative Vaccine Response to Hepatitis B (Hep B)Surface Antigen is defined as a “Responder” if serum a'body level is >= 10 mIU/mL and a “Non- Responder” if a serum antibody level is < 10 mIU/mL. Age was analyzed as a potential impact factor and was measured and examined for the association with both the presence of adequate response as well as the quantitative titer one month post 2 vaccine doses.
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.
Participants who had a Wk 28 hep B a'body titer were included. One subject had no results at Wk 28 but had results at entry and end of study (EOS). Since the EOS titer was > 10, this subject was included as a responder in qualitative analyses, but not in quantitative analyses, since the EOS titer is not sufficiently predictive of the Wk 28 titer.

Reporting Groups
  Description
15-17 Years of Age Subjects between the ages of 15 and 17 years, inclusive
12-14 Years of Age Subjects between the ages of 12 and 14 years, inclusive

Measured Values
    15-17 Years of Age     12-14 Years of Age  
Number of Participants Analyzed  
[units: participants]
  68     34  
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE  
[units: Participants]
   
Responder     61     32  
Non-Responder     7     2  


Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE
Groups [1] All groups
Method [2] Univariate regression, logistic
P Value [3] 0.4646
Odds Ratio (OR) [4] 1.84
95% Confidence Interval ( 0.36 to 9.36 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[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:
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[4] Other relevant estimation information:
  The reference group is the '15-17 year' age group



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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