Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15y

NCT00698061 | Completed Phase 3

• 2 other identifiers: 208129/033208129/038
• Study Type: interventional
• Target: 145
• Locations: 0 countries
• Sites: N/A

Brief Summary

Subjects who had not responded to previous hepatitis B vaccination were vaccinated with either the adjuvanted HBV-MPL vaccine or Engerix™-B vaccine according to a three-dose vaccination schedule (0, 1, 2 months) and boosted at Month 12 as per their group allocation. The immunogenicity and safety of the HBV-MPL vaccine were compared with the control vaccine, Engerix™-B.

Conditions

Hepatitis B

Keywords

Hepatitis B; Adjuvanted vaccine

Outcome Measures

Primary Outcomes (1)

• Anti-HBs antibody concentrations

  Months 1, 2 and 3

Secondary Outcomes (4)

• Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms

  During a 4 day follow-up period after vaccination

• Occurrence, intensity and relationship to vaccination of unsolicited signs and symptoms

  During a 30 day follow-up period after vaccination

• Occurrence, intensity and relationship to vaccination of serious adverse events (SAEs)

  During the study period, up to and including 6 months post-vaccination

• Anti-HBs antibody concentrations in all subjects

  Months 1, 2, 3, 12 and 13

Study Arms (2)

Group A

EXPERIMENTAL

Biological: HBV-MPL vaccine 208129

Group B

ACTIVE COMPARATOR

Biological: Engerix™-B

Interventions

HBV-MPL vaccine 208129 BIOLOGICAL

3-dose primary vaccination and booster vaccination by intramuscular injection

Group A

Engerix™-B BIOLOGICAL

3-dose primary vaccination and booster vaccination by intramuscular injection

Group B

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At study entry:
• A male or female ≥ 15 years of age at the time of the first vaccination.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.
• Written informed consent obtained from the subject.
• Documented non-response to previous hepatitis B vaccination within 6 months after having received a full vaccination course (i.e. ≥ 3 doses of a hepatitis B vaccine)
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to enrollment and up to two months after the last vaccination.
• Before booster dose at month 12:
• Additional written informed consent covering the booster administration and blood samples at months 12 and 13 must be obtained from the subject.
• If the subject is female, she must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or use adequate contraceptive precautions for one month prior to and up to two months after the administration of the booster dose

You may not qualify if:

• Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
• Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine and ending 30 days after.
• Known exposure to hepatitis B within 6 weeks.
• History of hepatitis B infection.
• Confirmed human immunodeficiency virus (HIV) infection.
• A family history of congenital or hereditary immunodeficiency.
• History of allergic disease/reactions likely to be exacerbated by any component of the vaccine.
• Acute disease at the time of enrollment.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration/ administration during the study period.
• Pregnant or lactating female.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.

  PMID: 18845199 BACKGROUND

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 16, 2008
• Study Start: November 1, 1999
• Primary Completion: September 1, 2000
• Study Completion: May 1, 2001
• Last Updated: May 30, 2017

Record last verified: 2017-05