Adolescents' Response to Hepatitis B Vaccine Booster Dose

Hepatitis B Clinical Trial

— REACH  

Official title:

Project to Evaluate Hepatitis B Vaccine-induced Immunity Among US-born Adolescents Who Received Hepatitis B Primary Vaccination Series During Early Childhood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01341275
• Other study ID #: H-26257
• Status: Recruiting
• Phase: Phase 4
• First received: April 22, 2011
• Last updated: April 22, 2011
• Start date: April 2010
• Est. completion date: November 2011

Study information

• Verified date: April 2011
• Source: Baylor College of Medicine
• Contact: Amy B Middleman, MD
• Phone: 832-822-3664
• Email: amym[@]bcm.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aims of this study are to determine:

1. the degree of immunity against hepatitis B,

2. factors associated with immunity against hepatitis B,

3. if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and

4. if the age at which the vaccination was initiated during infancy affects duration of protection against hepatitis B among adolescents 16-19 years of age born in the United States who were immunized against hepatitis B as infants. These data will be important to evaluate the potential need for a possible booster dose of hepatitis B vaccine among adolescents.

Study subjects eligible for enrollment will:

• have blood drawn for baseline serologies

• receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug dose)

• have blood drawn again 14 days later to determine if the booster dose has engendered an anamnestic response (a response attributed to prior immunity rather than a new response to the vaccine)

The primary hypothesis is that the majority of young people will exhibit immune memory for hepatitis B in response to a booster dose of vaccine.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 19 Years

Eligibility

Inclusion Criteria:

• 16-19 years of age

• born in the United States

• received the full hepatitis B vaccination series by 12 months of age

• received the third dose of hepatitis B vaccine within 10 months of the first dose

Exclusion Criteria:

• a history of hepatitis B disease

• being born to a mother with hepatitis B at the time of the participant's birth

• having received hepatitis B immune globulin as an infant

• immunosuppression including HIV or chronic/current steroid use (use > 10 days duration within the 3 months of enrollment)

• renal insufficiency or dialysis

• pregnancy (due to theoretical risk of different immune response among pregnant females)

• ever receiving a booster (fourth) dose of hepatitis B vaccine

• history of allergy to the hepatitis B vaccine

• receipt of blood products or IgG within 3 months of enrollment

• having received another vaccine within 2 weeks of enrollment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B

Intervention

Biological:
• hepatitis B vaccine
10 ug dose, one-time administration
• hepatitis B vaccine
20 ug dose, one-time administration

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas
United States	Texas Children's Pediatric Associates	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anti-HBSAg titers		13-15 days after enrollment and booster dose	No