Adolescents' Response to Hepatitis B Vaccine Booster Dose
REACH
Project to Evaluate Hepatitis B Vaccine-induced Immunity Among US-born Adolescents Who Received Hepatitis B Primary Vaccination Series During Early Childhood
1 other identifier
interventional
400
1 country
2
Brief Summary
The aims of this study are to determine:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2010
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 22, 2011
CompletedFirst Posted
Study publicly available on registry
April 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedApril 25, 2011
April 1, 2011
1.6 years
April 22, 2011
April 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
anti-HBSAg titers
13-15 days after enrollment and booster dose
Study Arms (4)
birth, lower dose booster
EXPERIMENTALAdolescents 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
birth, higher dose booster
EXPERIMENTALAdolescents 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
4 weeks, lower dose booster
EXPERIMENTALAdolescents 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
4 weeks, higher dose booster
EXPERIMENTALAdolescents 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
10 ug dose, one-time administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Texas Children's Hospital
Houston, Texas, 77030, United States
Texas Children's Pediatric Associates
Houston, Texas, 77030, United States
Related Publications (2)
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.
PMID: 25643863DERIVEDMiddleman 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.
PMID: 24843060DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 22, 2011
First Posted
April 25, 2011
Study Start
April 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
April 25, 2011
Record last verified: 2011-04