Status:
COMPLETED
Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Conditions:
Hepatitis B
Eligibility:
All Genders
12-17 years
Phase:
PHASE2
Brief Summary
This study will evaluate 2 licensed vaccine products (Recombivax and Twinrix) given in a two-dose schedule to youth at risk for hepatitis B and HIV infection to evaluate immunogenicity of the products...
Detailed Description
Hepatitis B (HBV) prophylactic immunization has been recommended for at-risk adolescents for more than 10 years although universal coverage has not been achieved. Vaccine response in healthy adolescen...
Eligibility Criteria
Inclusion
- HIV negative youth age 12-17 years (No serologic evidence of HIV infection).
- Negative hepatitis B serology. (No serologic evidence of hepatitis B surface antigen (HBSAg), hepatitis B surface antibody (HBsAb or anti-HBs) and hepatitis B core antibody (HBcAb or anti-HBc)).
- Either no prior hepatitis B immunizations or unknown or incomplete hepatitis B immunization status.
- Willing to participate in HIV risk-reduction counseling and computer assisted measurement of behaviors.
- Parent or legal guardian willing to provide written permission
- Females of childbearing potential must have a negative pregnancy test at screening and should agree to avoid pregnancy through the end of the vaccine phase of the study. Females who are engaging in sexual intercourse must be willing to practice a reliable method of birth control through the end of the vaccine-phase of the study (approximately 6 months). The decision of what is "reliable" is at the discretion of the site investigator.
Exclusion
- Presence of any serious illness requiring treatment with systemic medications, excluding treatment for asthma.
- Previous allergic reaction to any vaccines or to constituents of these vaccines (yeast, thimerosal or aluminum)
- Pregnancy
- Current immunomodulator therapy
- Receipt of immunosuppressor therapy (more than 10 mg/day of prednisone or equivalent for \>1 week) in the 6 months preceding entry or anticipated long-term corticosteroid therapy in the above dose and duration. Short term (\< 7 days) steroid use for the treatment of asthma is not an exclusion.
- Receipt of any vaccine within 2 weeks preceding study entry.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00107042
Start Date
February 1 2004
End Date
July 1 2008
Last Update
March 29 2017
Active Locations (11)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of California at San Diego
San Diego, California, United States, 92103
3
University of California at San Francisco
San Francisco, California, United States, 94118
4
Children's Hospital National Medical Center
Washington D.C., District of Columbia, United States, 20010