Effectiveness of Two Hepatitis B Vaccines in HIV-negative Youths

NCT00107042 | Completed Phase 2 Results DMC

• 1 other identifier: ATN 025
• Study Type: interventional
• Target: 123
• Locations: 2 countries
• Sites: 11

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).

Conditions

Hepatitis B

Keywords

Hepatitis B; HIV vaccine trial

Outcome Measures

Primary Outcomes (3)

• Qualitative Seroresponsiveness to Hepatitis B Surface Antigen

  Seroresponsiveness to Hepatitis B Surface Antigen is defined as follows: Responder: serum antibody level is greater than or equal to 10 mIU/mL. Non-responder: serum antibody level is less than 10 mIU/mL.

  Week (Wk) 28 (One month after the second immunization)

• Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix (Number of Participants With >=1 Adverse Event (AE))

  Frequency Distribution of AEs by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as "Any" vs. "None". In summarizing the distribution of AEs, the number of subjects with at least one event by preferred term and study arm were reported.

  Week 12, Week 24, Week 28, Week 76

• Safety and Tolerability of Vaccine Regimens of Recombivax and Twinrix: Serious Adverse Events (SAE)(Number of Subjects With >= 1 SAE)

  Frequency Distribution of SAE by Study Arm and Preferred Term. The safety and tolerability of each vaccine was assessed by measuring reactogenicity. The reactions were coded as "Any" vs. "None". The number of participants with at least one SAE is reported.

  Week 12, Week 24, Week 28, Week 76

Secondary Outcomes (26)

• Quantitative Vaccine Response

  Week 28

• Unadjusted Relationship of Hepatitis B Vaccine Response (Log10 Titer) and Potential Impact Factors Among Subjects Whose Week 28 Antibody Results Are Within Week 28 Visit Window.

  Week 28

• Outcome Measure: Qualitative Vaccine Response to Hepatitis B (Hep B) Surface Antigen (Binary); Predictor: STUDY ARM.

  Week 28

• Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: SITE EFFECT

  Week 28

• Outcome Measure: Qualitative Vaccine Response to Hepatitis B Surface Antigen (Binary); Predictor: AGE

  Week 28

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Biological: Recombivax

2

EXPERIMENTAL

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.

Biological: Twinrix

Interventions

Recombivax BIOLOGICAL

Participants receive doses of Recombivax at weeks 0 and 24.

1

Twinrix BIOLOGICAL

Participants receive doses of Twinrix at weeks 0 and 24.

2

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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 any vaccine within 2 weeks preceding study entry.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• National Institute of Mental Health (NIMH): collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (11)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

University of California at San Diego

San Diego, California, 92103, United States

Location

University of California at San Francisco

San Francisco, California, 94118, United States

Location

Children's Hospital National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Southern Florida College of Medicine

Tampa, Florida, 33606, United States

Location

Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital

Chicago, Illinois, 60612, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

St. Jude Childrens Research Hospital

Memphis, Tennessee, 38105-2794, United States

Location

Unversity of Peurto Rico School of Medicine

San Juan, 00936, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 20173677 DERIVED

Related Links

• Adolescent Trials Network for HIV/AIDS Intervention

MeSH Terms

Conditions

Hepatitis B

Interventions

Recombivax HB; twinrix

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Dr. Bob Harris
• Organization: Westat

bobharris@westat.com

301-251-1500

Study Officials

• Coleen K. Cunningham, MD

  Duke University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2005
• First Posted: April 5, 2005
• Study Start: February 1, 2004
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 29, 2017
• Results First Posted: December 4, 2012

Record last verified: 2016-03

Locations

US (10); PR (1)