Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02153320
Other study ID # 105721
Secondary ID
Status Completed
Phase Phase 1
First received May 22, 2014
Last updated May 24, 2017
Start date September 5, 2005
Est. completion date October 28, 2005

Study information

Verified date May 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this long-term follow-up study was to evaluate the persistence of the cellular and the humoral immune response 4 years after the first dose of GSK Biologicals' investigational vaccine formulations containing HBsAg (used as a model antigen) and an adjuvant.


Description:

Subjects in this long-term follow-up study were recruited among those subjects who completed the study 287615 (NCT00508833) and who were enrolled in specific groups. All subjects were vaccinated in the study 287615 (NCT00508833) according to a 0, 1, 10 month schedule. No new subjects were enrolled and no vaccine was administered in this long-term follow-up study. There was a single visit at Year 4 at which blood samples for immunogenicity assays were taken.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date October 28, 2005
Est. primary completion date October 28, 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years to 45 Years
Eligibility Inclusion Criteria:

- Subjects who the investigator believes can and will comply with the requirements of the protocol.

- Subjects who took part in and completed study 287615 (NCT00508833).

- Written informed consent obtained from the subject.

- Healthy subjects as established by medical history before entering into the study.

Exclusion Criteria:

- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the blood sampling, or planned use during the study period.

- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to the blood sampling.

- Administration of immunoglobulins within the three months preceding the blood sampling or planned administration during the study period.

- Pregnant or lactating female.

- Documented HIV-positive subject.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Blood Sampling
Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).

Locations

Country Name City State
Belgium GSK Investigational Site Bruxelles
Belgium GSK Investigational Site Gent

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of CD4 and CD8 T cells expressing IFN-? and/or TNF-a and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry. The blood samples at Week 48 were taken during the primary study 287615 (NCT00508833). Week 48.
Primary Frequency of CD4 and CD8 T cells expressing IFN-? and/or TNF-a and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry. The blood samples at Week 78 were taken during the primary study 287615 (NCT00508833). Week 78.
Primary Frequency of CD4 and CD8 T cells expressing IFN-? and/or TNF-a and/or IL-2 and/or CD40L upon short term in vitro stimulation with HbsAg derived peptides using cytokine flow cytometry. Year 4.
Secondary Anti-HBs antibody titres as measured by ELISA. The blood samples at Week 48 and Week 78 were taken during the primary study 287615 (NCT00508833). Week, 48, Week 78, Year 4.
Secondary Exploratory analysis of proteins and low molecular weight biomolecules in the serum using ELISA and other techniques to be defined. The blood samples at Day 0 and Day 1 were taken during the primary study 287615 (NCT00508833). Day 0, Day 1.
Secondary Frequency of HBsAg specific memory B cells by B Cell Elispot assay. The blood samples at Week 48 and Week 78 were taken during the primary study 287615 (NCT00508833). Week 48, Week 78, Year 4.
Secondary Frequency of HBs-specific or non specific T regulatory cells using cytokine flow cytometry and other techniques to be defined. The blood samples at Day 0, Week 6, Week 46 and Week 48 were taken during the primary study 287615 (NCT00508833). Day 0, Week 6, Week 46, Week 48.
See also
  Status Clinical Trial Phase
Completed NCT01182311 - Duration of Long-term Immunity After Hepatitis B Virus Immunization
Completed NCT04971928 - Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment Phase 1
Completed NCT03285620 - A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants Phase 1
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05404919 - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Phase 2
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Completed NCT03567382 - Arresting Vertical Transmission of Hepatitis B Virus Phase 4
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Not yet recruiting NCT03604016 - Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Recruiting NCT03027258 - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome N/A
Completed NCT02540538 - Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders Phase 1
Terminated NCT02604199 - A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection Phase 2
Completed NCT02421666 - A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV N/A
Completed NCT02169674 - Hepatitis B Booster Study in Adolescence Phase 4
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01368497 - Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection Phase 3
Completed NCT01732354 - Study for Consolidation Period of Chronic Hepatitis B
Recruiting NCT01462981 - Cohort of Hepatitis B Research of Amsterdam N/A
Enrolling by invitation NCT01548326 - Effects of Short-term Atorvastatin Treatment on Vaccination Efficacy in Nonresponder Persons to Hepatitis B Vaccine Phase 4