Hepatitis B Clinical Trial
Official title:
Hepatitis B Vaccination in Youth at Adolescent Trial Network Sites: Effectiveness of Two Strategies and Evaluation of Tools To be Used in Future HIV Prevention Trials.
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).
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 adolescents has generally been reported to be excellent. But, data from the study
Reaching for Excellence in Adolescent Care and Health (REACH) that studied HIV-negative
adolescents who were at-risk of acquiring Hepatitis B infection through sexual or needle
sharing behaviors has demonstrated a much lower than expected vaccine response rate in this
population using standard vaccine dosing. Some data suggest that factors such as gender or
body mass index might be responsible for the differences in response to the vaccine observed
in individuals. The reason for the diminished vaccine response in this population is
unclear. If in fact, Hepatitis B vaccine response is diminished in this population, then
efforts to determine correlates of response and to improve the response are warranted. The
proposed trial will evaluate 2 licensed vaccine products given in a two-dose schedule in
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,
participation in such trials will require ability to understand and willingness to volunteer
for such trials, ability to return for multiple vaccinations and blood draws to assess
vaccine response, and willingness to participate in HIV prevention education. A hepatitis B
vaccine trial will provide a licensed vaccine to youth in whom the vaccine is indicated and
will allow preliminary assessment of youth's willingness to participate in a vaccine trial
that involves blood draws for immunologic assessment.
Tools that will be necessary for HIV vaccine trials in youth include a youth-friendly
simplified vaccine trial education component with a required written test for the
participant, a standardized risk reduction education program, and a computer-assisted
assessment of youth behaviors. These tools can be finalized and field tested in youth
participating in the hepatitis B vaccine trial without promoting a false sense of protection
from HIV. Secondary objectives of this trial will include assessment of a number of
ancillary tools crucial for future HIV vaccine trials. This Hepatitis B vaccine trial will
also serve as a HIV vaccine preparedness trial for youth at risk for both Hepatitis B and
HIV.
Design: This is a phase II, randomized, single-blinded trial of two hepatitis B immunization
regimens in 150 HIV-negative, hepatitis B core antibody, hepatitis B surface antigen and
surface antibody negative youth. Vaccinations will be given in a two-dose regimen at 0 and
six months (75 subjects in each arm) and the primary outcome will be seroresponsiveness one
month after the 6-month dose. Safety and tolerability will also be assessed.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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