Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:12 - 17
Updated:4/21/2016
Start Date:February 2004
End Date:July 2008

Use our guide to learn which trials are right for you!

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.

Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
11
sites
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
?
mi
from
Bronx, NY
Click here to add this to my saved trials
4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
San Diego, California 92093
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
San Juan,
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Washington, District of Columbia 20010
?
mi
from
Washington,
Click here to add this to my saved trials