Recruiting

Hepatitis B Vaccine

Sponsor:

Baylor College of Medicine

Code:

NCT01341275

Conditions

Hepatitis B

Eligibility Criteria

Sex: All

Age: 16 - 19

Healthy Volunteers: Not accepted

Interventions

hepatitis B vaccine

hepatitis B vaccine

Study Details

Brief 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.

Conditions

Hepatitis B

Study ID

NCT01341275

Start date

Apr, 2010

Status verified date

Apr, 2011

Completion date

Nov, 2011

Anticipated

Primary completion date

Nov, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 19

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: birth, lower dose booster

Adolescents who received their first dose of hepatitis B vaccine at or before day 7 of life who received a 10 ug dose of hepatitis B vaccine as a booster

experimental: birth, higher dose booster

Adolescents who received their first dose of hepatitis B vaccine at or before day 7 of life who received a 20 ug dose of hepatitis B vaccine as a booster

experimental: 4 weeks, lower dose booster

Adolescents who received their first dose of hepatitis B vaccine at or after 4 weeks of life who received a 10 ug dose of hepatitis B vaccine as a booster

experimental: 4 weeks, higher dose booster

Adolescents who received their first dose of hepatitis B vaccine at or after 4 weeks of life who received a 20 ug dose of hepatitis B vaccine as a booster

Interventions

hepatitis B vaccine

10 ug dose, one-time administration

hepatitis B vaccine

20 ug dose, one-time administration

Primary outcome measure

  • anti-HBSAg titers [ Time Frame: 13-15 days after enrollment and booster dose ]

Central Contacts and Locations

Central contacts

Amy B Middleman, MD

832-822-3664amym@bcm.edu

Locations

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Texas Children's Pediatric Associates

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Baylor College of Medicine

Last update posted

Apr 25, 2011

Last verified

Apr, 2011

Keywords

  • hepatitis B vaccine
  • duration of protection
  • adolescent immunization
  • anamnestic response
  • booster dose
  • Immunity to hepatitis B as measured by anti-HBSAg titers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2011-04-25.