Adolescents' Response to Hepatitis B Vaccine Booster Dose (REACH)

Baylor College of Medicine

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B

Treatments: Biological: hepatitis B vaccine

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01341275

H-26257

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 16 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

birth, lower dose booster

Experimental group

Description:

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

Treatment:

Biological: hepatitis B vaccine

Biological: hepatitis B vaccine

birth, higher dose booster

Experimental group

Description:

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

Treatment:

Biological: hepatitis B vaccine

Biological: hepatitis B vaccine

4 weeks, lower dose booster

Experimental group

Description:

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

Treatment:

Biological: hepatitis B vaccine

Biological: hepatitis B vaccine

4 weeks, higher dose booster

Experimental group

Description:

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

Treatment:

Biological: hepatitis B vaccine

Biological: hepatitis B vaccine