Evaluation of Antibody Persistence and Immune Memory Against the Hepatitis B Antigen in Previously Vaccinated Children

NCT01138098 | Completed Phase 4 Results

• 1 other identifier: 113954
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 11

Brief Summary

This study will evaluate the persistence of immunity to hepatitis B 10 to 11 years after vaccination with Infanrix hexa™ or Engerix™-B and also the ability to mount an immune response to the challenge dose of Engerix™-B.

Conditions

Hepatitis B

Keywords

Persistence; challenge dose; Engerix-B; immune response

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 100 Milli-International Units Per Milliliter (mIU/mL)

  A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

  One month after a challenge dose of Engerix-B vaccine

Secondary Outcomes (8)

• Number of Subjects With an Anamnestic Response to a Challenge Dose

  Before and one month after a challenge dose of Engerix-B vaccine

• Number of Subjects With Anti-HBs Antibody Concentration ≥ 6.2 mIU/mL

  Before and one month after a challenge dose of Engerix-B vaccine

• Number of Subjects With Anti-HBs Antibody Concentration ≥ 10 mIU/mL

  Before and one month after a challenge dose of Engerix-B vaccine

• Number of Subjects With Anti-HBs Antibody Concentration ≥ 100 mIU/mL

  Before the challenge dose of Engerix-B vaccine

• Number of Subjects Reporting Solicited Local Symptoms

  During the 4-day (Days 0-3) follow-up period after a challenge dose of Engerix-B vaccine

Study Arms (2)

Infanrix-hexa/Engerix-B Group

EXPERIMENTAL

Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (217744/031 (NCT01457495)) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.

Biological: Engerix™-B

Infanrix-IPV+Hib/Engerix-B Group

ACTIVE COMPARATOR

Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (217744/031 (NCT01457495)) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.

Biological: Engerix™-B

Interventions

Engerix™-B BIOLOGICAL

Intramuscular, single dose

Infanrix-IPV+Hib/Engerix-B Group; Infanrix-hexa/Engerix-B Group

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parents/Legally acceptable representative) can and will comply with the requirements of the protocol should be enrolled in the study.
• A male or female aged 11-12 years at the time of study entry (from and including the 11th birthday until and excluding the 13th birthday).
• Written informed consent obtained from the parent or Legally Acceptable Representative of the subject.
• Study procedures will be explained to subjects and depending on their understanding, optional informed assent will be sought at the discretion of the investigator.
• Written informed assent obtained from the subject in addition to the informed consent signed by the parent(s)/ Legally Acceptable Representative (s).
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects who have received all three doses of Infanrix hexa or Engerix-B in the primary study 217744/031 (NCT01457495).
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

You may not qualify if:

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
• Child in care.
• Use of any investigational or non-registered product drug or vaccine) other than the study vaccine within 30 days preceding the challenge dose of HBV vaccine, or planned use during the study period.
• Receipt of hepatitis B (containing) vaccine after vaccination in the primary study 217744/031 (NCT01457495).
• History of hepatitis B disease.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after the HBV vaccine challenge dose.
• Administration of immunoglobulins and/or any blood products within the three months preceding the challenge dose of HBV vaccine or planned administration during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose of HBV vaccine.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Known hypersensitivity to any component of the HBV vaccine or evidence of hypersensitivity after previous immunisation with a vaccine containing the hepatitis B component.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (11)

GSK Investigational Site

Banská Bystrica, 974 01, Slovakia

Location

GSK Investigational Site

Dolný Kubín, 026 01, Slovakia

Location

GSK Investigational Site

Dubnica nad Váhom, 018 41, Slovakia

Location

GSK Investigational Site

Martin, 036 01, Slovakia

Location

GSK Investigational Site

Nitra, 949 01, Slovakia

Location

GSK Investigational Site

Nová Dubnica, 018 51, Slovakia

Location

GSK Investigational Site

Nové Zámky, 940 01, Slovakia

Location

GSK Investigational Site

Púchov, 020 01, Slovakia

Location

GSK Investigational Site

Rožňava, 048 01, Slovakia

Location

GSK Investigational Site

Trebišov, 075 01, Slovakia

Location

GSK Investigational Site

Zlaté Moravce, 953 01, Slovakia

Location

Related Publications (1)

• Avdicova M, Crasta PD, Hardt K, Kovac M. Lasting immune memory against hepatitis B following challenge 10-11 years after primary vaccination with either three doses of hexavalent DTPa-HBV-IPV/Hib or monovalent hepatitis B vaccine at 3, 5 and 11-12 months of age. Vaccine. 2015 May 28;33(23):2727-33. doi: 10.1016/j.vaccine.2014.06.070. Epub 2014 Jun 22.

  PMID: 24962750 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: June 7, 2010
• Study Start: June 7, 2010
• Primary Completion: November 26, 2010
• Study Completion: November 26, 2010
• Last Updated: August 20, 2018
• Results First Posted: December 21, 2011

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

SL (11)