Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107042
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2005-04-04
Brief Title:
Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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 youths 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
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 youths 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None