Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths

Completed · Phase 2

Conditions studied: Hepatitis B

In brief

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 in this population, barriers to vaccine delivery, and factors which predict a diminished immune response. Since these youths are also potential candidates for future HIV vaccine trials, this study will also include preliminary assessment of youths' understanding of informed consent forms, and willingness to participate in a vaccine trial and return for multiple visits (including blood draws for immunologic assessment).

Key facts

Study ID

NCT00107042

Run by

University of North Carolina, Chapel Hill

People needed

123

Starts

2004-02-01

Expected to finish

2008-07-01

Last updated by the study team

2017-03-29

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• University of California at San Diego — San Diego, California, United States
• University of California at San Francisco — San Francisco, California, United States
• Children's Hospital National Medical Center — Washington D.C., District of Columbia, United States
• University of Southern Florida College of Medicine — Tampa, Florida, United States
• Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital — Chicago, Illinois, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Montefiore Medical Center — The Bronx, New York, United States
• St. Jude Childrens Research Hospital — Memphis, Tennessee, United States
• Unversity of Peurto Rico School of Medicine — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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