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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Baylor College of Medicine.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Centers for Disease Control and Prevention

Information provided by:

Baylor College of Medicine

ClinicalTrials.gov Identifier:

NCT01341275

First received: April 22, 2011

Last updated: NA

Last verified: April 2011

History: No changes posted

Purpose

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.

Condition	Intervention	Phase
Hepatitis B	Biological: hepatitis B vaccine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Project to Evaluate Hepatitis B Vaccine-induced Immunity Among US-born Adolescents Who Received Hepatitis B Primary Vaccination Series During Early Childhood

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Recombinant Hepatitis B vaccine Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

anti-HBSAg titers [ Time Frame: 13-15 days after enrollment and booster dose ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	April 2010
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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	Biological: hepatitis B vaccine 10 ug dose, one-time administration Other Name: EngerixB
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	Biological: hepatitis B vaccine 20 ug dose, one-time administration Other Name: EngerixB
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	Biological: hepatitis B vaccine 10 ug dose, one-time administration Other Name: EngerixB
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	Biological: hepatitis B vaccine 20 ug dose, one-time administration Other Name: EngerixB

Eligibility

Ages Eligible for Study:	16 Years to 19 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341275

Contacts

Contact: Amy B Middleman, MD

832-822-3664

amym@bcm.edu

Locations

United States, Texas
Texas Children's Pediatric Associates	Recruiting
Houston, Texas, United States, 77030
Texas Children's Hospital	Recruiting
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Centers for Disease Control and Prevention

More Information

No publications provided

Responsible Party:	Amy B. Middleman, MD, MSEd, MPH/Associate Professor of Pediatrics, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT01341275 History of Changes
Other Study ID Numbers:	H-26257
Study First Received:	April 22, 2011
Last Updated:	April 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

hepatitis B vaccine
duration of protection
adolescent immunization

anamnestic response
booster dose
Immunity to hepatitis B as measured by anti-HBSAg titers

Additional relevant MeSH terms:

Hepatitis B
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human

Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 23, 2013

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