LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers - Full Text View

Purpose

To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Condition	Intervention	Phase
Hepatitis B	Biological: Engerix™ -B Biological: Hepatitis B immunoglobulin (HBIg)	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Long-Term Follow-up Study at Years 16, 17, 18, 19 and 20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine Administered With or Without HBIG in Newborns of HBeAg+ Mothers

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

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

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration [ Time Frame: Years 15, 16, 17, 18, 19 and 20 ] [ Designated as safety issue: No ]
Concentrations given as GMC expressed as milli-international unit per millilitre (mIU/mL).
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values [ Time Frame: Years 15, 16, 17, 18, 19 and 20 ] [ Designated as safety issue: No ]
Anti-hepatitis B surface antigen (anti-HBs) antibody cut-off values assessed include 1.0 and 10 mIU/mL.
Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection [ Time Frame: Years 15, 16, 17, 18, 19 and 20 ] [ Designated as safety issue: No ]
Serological markers for hepatitis B infection assessed are hepatitis B surface antigen (HBsAg), antibodies to hepatitis B core antigen (anti-HBc), hepatitis B e antigen (HBeAg) and antibodies to hepatitis B e antigen (anti-HBe).
Number of Subjects With Different Hepatitis B Infection Statuses [ Time Frame: Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point) ] [ Designated as safety issue: No ]
Categories hepatitis B (HB) infection:
1. Chronic infection: HBsAg and anti-HBc pos (pos) in more than two consecutive samples
2. False positive: single HB marker (HBsAg, HBeAg, anti-HBc) pos + all other markers negative (neg) in one sample. Consecutive time points all neg.
3. Possible subclinical breakthrough infection: One or more HB markers pos in one or more consecutive samples.
4. Isolated natural booster: >4-fold increase of anti-HBs concentrations if <100 mIU/mL at previous sample OR >2- fold increase of anti-HBs concentrations if >=100 mIU/mL at previous sample + other markers neg

Enrollment:	79
Study Start Date:	October 2003
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Engerix 4D + HBIg Group Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.	Biological: Engerix™ -B 3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study Biological: Hepatitis B immunoglobulin (HBIg) 1 intramuscular injections at birth (primary study)
Experimental: Engerix 3D + HBIg Group Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.	Biological: Engerix™ -B 3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study Biological: Hepatitis B immunoglobulin (HBIg) 1 intramuscular injections at birth (primary study)
Experimental: Engerix 4D Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.	Biological: Engerix™ -B 3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study
Experimental: Engerix 3D Group Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6.	Biological: Engerix™ -B 3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study

Detailed Description:

The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a dose of HBIg at birth. The current study describes the long term follow up of these subjects between Y16 and 20 after primary vaccination.

Eligibility

Ages Eligible for Study:	16 Years to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects who had received at least one dose of the study vaccine in the primary study
Written informed consent obtained from each subject before each blood sampling visit

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00240526

Locations

Thailand
GSK Investigational Site
Bangkok, Thailand, 10330

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

Poovorawan Y, Chongsrisawat V, Theamboonlers A, Srinivasa K, Hutagalung Y, Bock HL, Hoet B. Long-term benefit of hepatitis B vaccination among children in Thailand with transient hepatitis B virus infection who were born to hepatitis B surface antigen-positive mothers. J Infect Dis. 2009 Jul 1;200(1):33-8.

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

Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Crasta PD, Hardt K. Persistence and immune memory to hepatitis B vaccine 20 years after primary vaccination of Thai infants, born to HBsAg and HBeAg positive mothers. Hum Vaccin Immunother. 2012 Jul;8(7):896-904. doi: 10.4161/hv.19989. Epub 2012 Jul 1.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00240526 History of Changes
Other Study ID Numbers:	100450
Study First Received:	October 13, 2005
Results First Received:	June 14, 2010
Last Updated:	February 17, 2011
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by GlaxoSmithKline:

Hepatitis B immunoglobulin
Hepatitis B antibody persistence

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections

RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Immunoglobulins
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013