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Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths

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):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00107042
First received: April 4, 2005
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
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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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) ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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

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 ]
  Show Outcome Measure 5

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

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

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

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

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

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

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

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

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

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

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

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 ]
  Show Outcome Measure 17

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

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

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

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

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

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

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

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

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

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 ]
  Show Outcome Measure 27

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

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


  Serious Adverse Events
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Time Frame No text entered.
Additional Description 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

Serious Adverse Events
    Recombivax     Twinrix  
Total, serious adverse events      
# participants affected / at risk     2/60 (3.33%)     2/63 (3.17%)  
General disorders      
Asthenia 1 [3]    
# participants affected / at risk     1/60 (1.67%)     0/63 (0.00%)  
# events     1     0  
Injury, poisoning and procedural complications      
Forearm Fracture † 1 [4]    
# participants affected / at risk     1/60 (1.67%)     0/63 (0.00%)  
# events     1     0  
Road Traffic Accident † 1 [5]    
# participants affected / at risk     0/60 (0.00%)     1/63 (1.59%)  
# events     0     1  
Psychiatric disorders      
Anxiety † 1 [5]    
# participants affected / at risk     0/60 (0.00%)     1/63 (1.59%)  
# events     0     1  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 6.0
[3] In Addition to MedDRA 6.0, WHODD 2003, 2nd quarter was used for coding.
[4] WHODD 2003, 2nd quarter
[5] WHODD 2003, 2nd quarter also used for coding




  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: James Korelitz
Organization: Westat
phone: 301-251-1500
e-mail: jameskorelitz@westat.com


No publications provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications automatically indexed to this study:


Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00107042     History of Changes
Other Study ID Numbers: ATN 025
Study First Received: April 4, 2005
Results First Received: September 5, 2011
Last Updated: October 26, 2012
Health Authority: United States: Federal Government