Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths

NCT ID: NCT00107042

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2008-07-31

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 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.

Conditions

Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1

Participants receive doses of Recombivax at weeks 0 and 24. A risk-behavior assessment is administered at week 12 and post-vaccination follow-up visits and bloodwork occur at weeks 28 and 76.

Group Type: ACTIVE_COMPARATOR

Recombivax

Intervention Type: BIOLOGICAL

Participants receive doses of Recombivax at weeks 0 and 24.

2

Participants receive doses of Twinrix at weeks 0 and 24. A risk-behavior assessment is administered at week 12 and post-vaccination follow-up visits and bloodwork occur at weeks 28 and 76.

Group Type: EXPERIMENTAL

Twinrix

Intervention Type: BIOLOGICAL

Participants receive doses of Twinrix at weeks 0 and 24.

Interventions

Recombivax

Participants receive doses of Recombivax at weeks 0 and 24.

Intervention Type: BIOLOGICAL

Twinrix

Participants receive doses of Twinrix at weeks 0 and 24.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Coleen K. Cunningham, MD

Role: STUDY_CHAIR

Duke University

Locations

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

Countries

United States; Puerto Rico

References

Cunningham CK, Rudy BJ, Xu J, Bethel J, Kapogiannis BG, Ahmad S, Wilson CM, Flynn PM; Adolescent Medicine Trials Network for HIV/AIDS Interventions. Randomized trial to determine safety and immunogenicity of two strategies for hepatitis B vaccination in healthy urban adolescents in the United States. Pediatr Infect Dis J. 2010 Jun;29(6):530-4. doi: 10.1097/INF.0b013e3181d285c7.

Reference Type: DERIVED

PMID: 20173677 (View on PubMed)

Related Links

http://www.atnonline.org

Adolescent Trials Network for HIV/AIDS Intervention

Other Identifiers

ATN 025

Identifier Type: -

Identifier Source: org_study_id