Adolescents' Response to Hepatitis B Vaccine Booster Dose

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to determine: the degree of immunity against hepatitis B, factors associated with immunity against hepatitis B, 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 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.

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

Conditions
-----------------
Hepatitis B

Intervention / Treatment
-----------------
* Biological: hepatitis B vaccine
* Biological: hepatitis B vaccine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: birth, lower dose booster<br>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 | Biological: hepatitis B vaccine<br>* 10 ug dose, one-time administration<br>* Other names: EngerixB;|
| Experimental: birth, higher dose booster<br>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 | Biological: hepatitis B vaccine<br>* 20 ug dose, one-time administration<br>* Other names: EngerixB;|
| Experimental: 4 weeks, lower dose booster<br>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 | Biological: hepatitis B vaccine<br>* 10 ug dose, one-time administration<br>* Other names: EngerixB;|
| Experimental: 4 weeks, higher dose booster<br>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 | Biological: hepatitis B vaccine<br>* 20 ug dose, one-time administration<br>* Other names: EngerixB;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anti-HBSAg titers |  | 13-15 days after enrollment and booster dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis B vaccine, duration of protection, adolescent immunization, anamnestic response, booster dose, Immunity to hepatitis B as measured by anti-HBSAg titers