Clinical trial NCT01341275: Adolescents' Response to Hepatitis B Vaccine Booster Dose
Official title: Project to Evaluate Hepatitis B Vaccine-induced Immunity Among US-born Adolescents Who Received Hepatitis B Primary Vaccination Series During Early Childhood
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Keywords: hepatitis B vaccine
duration of protection
adolescent immunization
anamnestic response
booster dose
Immunity to hepatitis B as measured by anti-HBSAg titers
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2011-04-25
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: anti-HBSAg titers
timeFrame: 13-15 days after enrollment and booster dose
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: Texas Children's Pediatric Associates
state: Texas
Study officials:
References:
citation: Spradling PR, Kamili S, Xing J, Drobeniuc J, Hu DJ, Middleman AB. Response to challenge dose among young adults vaccinated for hepatitis B as infants: importance of detectable residual antibody to hepatitis B surface antigen. Infect Control Hosp Epidemiol. 2015 May;36(5):529-33. doi: 10.1017/ice.2015.6. Epub 2015 Feb 3.
citation: Middleman AB, Baker CJ, Kozinetz CA, Kamili S, Nguyen C, Hu DJ, Spradling PR. Duration of protection after infant hepatitis B vaccination series. Pediatrics. 2014 Jun;133(6):e1500-7. doi: 10.1542/peds.2013-2940. Epub 2014 May 19.