Trial record 9 of 236 for:    Open Studies | "Hepatitis B"

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:
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:

  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.


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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided by Baylor College of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 28, 2014