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
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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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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) ]

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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 ]

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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 ]

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4. Secondary:

Quantitative Vaccine Response [ Time Frame: Week 28 ]

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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 ]

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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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 ]

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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 ]

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18. Secondary:

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

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Measure Type	Secondary
Measure Title	Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS
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. Total number of lifetime sex partners 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
0 Sex Partners	Subjects who have never had a sex partner
1 - 5 Sex Partners	Subjects who have had 1 - 5 lifetime sex partners
>= 6 Sex Partners	Subjects who have had 6 or more lifetime sex partners

Measured Values

	0 Sex Partners	1 - 5 Sex Partners	>= 6 Sex Partners
Number of Participants Analyzed [units: participants]	62	26	12
Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS [units: Participants]
Responder	59	26	7
Non-responder	3	0	5

Statistical Analysis 1 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS

Groups ^[1]	0 Sex Partners vs. >= 6 Sex Partners
Method ^[2]	Univariate regression, logistic
P Value ^[3]	0.0042
Odds Ratio (OR) ^[4]	0.08
95% Confidence Interval	( 0.01 to 0.48 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant 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:
	The reference group is the "0 partners" group

Statistical Analysis 2 for Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: TOTAL LIFETIME SEX PARTNERS

Groups ^[1]	0 Sex Partners vs. 1 - 5 Sex Partners
Method ^[2]	Univariate regression, Logistic
P Value ^[3]	0.6893
Odds Ratio (OR) ^[4]	1.65

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant 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:
	The reference group is the "0 partners" group. Two sided 95% confidence interval: Lower Limit = 0.17; upper limit = infinity

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 ]

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22. Secondary:

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

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23. Secondary:

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

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24. Secondary:

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

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25. Secondary:

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

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26. Secondary:

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

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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 ]

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28. Secondary:

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

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29. Secondary:

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

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Serious Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions Publication Policy outlines procedures for the development and review of abstracts, publications and presentations. The Adolescent Medicine Leadership Group (AMLG) retains custody of and primary rights to the data. Use of data must be approved by the protocol team and AMLG.

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
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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:

Cunningham CK, Rudy BJ, Xu J, Bethel J, Kapogiannis BG, Ahmad S, Wilson CM, Flynn PM; Adolescent Medicine Trials Network for HIV/AIDS Interventions. Randomized trial to determine safety and immunogenicity of two strategies for hepatitis B vaccination in healthy urban adolescents in the United States. Pediatr Infect Dis J. 2010 Jun;29(6):530-4.

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

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