Clinical trial NCT00445185: Study Evaluating Persistence of Anti-HBs Antibodies in Uraemic Patients Receiving Henogen's HBV Vaccine, or Fendrix™
Official title: A Study to Evaluate the Persistence of Anti-HBs Antibodies at Months 12, 24 and 36 in Pre-dialysis or Dialysis Patients Who Have Received a Primary Vaccination Course of Either Henogen's HBV Vaccine, HB-AS02V or GSK Biological's Fendrix™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Keywords: Dialysis
Pre-dialysis
Hepatitis B vaccine
vaccine
Lead sponsor: Henogen
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 102
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current extension study will assess the persistence of anti-HBs antibodies at Months 12, 24 and 36 after primary vaccination with Henogen's HBV vaccine or Fendrix™. This protocol posting deals with the objectives \& outcome measures of the extension phase at Months 12, 24 and 36. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT00291941).

Detailed description: Subjects who received complete full vaccination with Henogen HBV adjuvanted vaccine or Fendrix™ will participate in this persistence study for three long-term time points (12, 24 and 36 months after the first dose of primary vaccination). Blood sampling will be done at each time point to measure immune persistence.

Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained from the subject/ from the parent/ guardian of the subject.
* Subjects who completed the full course of primary vaccination.

Exclusion Criteria:

* Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
* Any confirmed or suspected human immunodeficiency virus (HIV) infection.

Primary outcomes:
measure: Anti-HBs antibody concentrations
timeFrame: Months 12, 24 and 36.
Secondary outcomes:
measure: Quality of immune response
timeFrame: Month 12, 24 and 36
measure: SAEs retrospective reporting
timeFrame: Month 12, 24 and 36
measure: RF-1 like antibody concentrations in the subset of subjects for whom this analysis was done at the primary study (HN014/HBV-001).
timeFrame: Month 12, 24 and 36
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: O.L.Vrouwziekenhuis Aalst
city: Ath
country: Belgium
facility: RHMS La Madeleine ATH
city: Baudour
country: Belgium
facility: RHMS Clinique Louis Caty Baudour
city: Bruxelles
country: Belgium
facility: CHU Brugmann (site V Horta) Service de néphrologie
city: Bruxelles
country: Belgium
facility: ULB Hôpital Erasme Département de Néphrologie
city: Bruxelles
country: Belgium
facility: AZ -VUB Dienst Nefrologie
city: Bruxelles
country: Belgium
facility: Cliniques universitaires Saint Luc
city: Charleroi
country: Belgium
facility: CHU Hôpital civil de
city: Gent
country: Belgium
facility: UZ Gent
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Leuven
country: Belgium
facility: UZ Gasthuisberg Leuven Nierziekten
city: Montigny Le Tilleul
country: Belgium
facility: CHU Andre VESALE
city: Tournai
country: Belgium
facility: RHMS TournayService de néphrologie
city: Jihlava
country: Czech Republic
facility: Hospital JihlavaVrchlického
city: Liberec
country: Czech Republic
facility: Regional Hospital Liberec
city: Ostrava
country: Czech Republic
facility: University Hospital with Outpatient Clinic Ostrava
city: Prague
country: Czech Republic
facility: Dept. of Internal Medicine StrahovSermirska 5
city: Usti Nad Labem
country: Czech Republic
facility: Masaryk´s Hospital Socialni pece 3316/12A
city: Budapest
country: Hungary
facility: St. Rókus Hospital
city: Budapest
country: Hungary
facility: St. István Hospital
city: Győr
country: Hungary
facility: Petz Aladár Teaching Hospital
city: Kistarcsa
country: Hungary
facility: Pest County Flór Ferenc Hospital
city: Szombathely
country: Hungary
facility: Vas and Szombathely County Markusovszky Hospital
Study officials:
affiliation: ULB Hôpital Erasme Département de Néphrologie
name: Joëlle Nortier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Surquin M, Tielemans C, Nortier J, Jadoul M, Peeters P, Ryba M, Roznovsky L, Doman J, Barthelemy X, Crasta PD, Messier M, Houard S. Anti-HBs antibody persistence following primary vaccination with an investigational AS02(v)-adjuvanted hepatitis B vaccine in patients with renal insufficiency. Hum Vaccin. 2011 Sep;7(9):913-8. doi: 10.4161/hv.7.9.16225. Epub 2011 Sep 1.