Estimating the immune system in adults who do not develop sufficient levels of antibodies after vaccination against hepatitis B virus

Phase 1

• Conditions: Healthy individuals; MedDRA version: 13.1Level: PTClassification code 10060023Term: Interferon gamma levelSystem Organ Class: 10022891 - Investigations; MedDRA version: 13.1Level: PTClassification code 10054130Term: Hepatitis B immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-001943-60-DK
• Lead Sponsor: ars Jørgen Østergaard

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1) Written informed consent and authority statement provided according
to local regulatory and ethical practice using a participant information
sheet and informed consent form approved by the responsible Ethics Committee.
2) Male or female participants = 18 years.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Allergy to formaldehyde (contained in Twinrix)
2) Former HBV immunization
3) Former HBV infection
4) Known chronic HBV infection
5) Participants unwilling to use reliable contraception for the duration of the trial (if female). Reliable methods of birth control include:
pharmacologic contraceptives including oral, parenteral and transdermal
delivery, surgical sterilization, vaginal ring, intrauterine device,
abstinence and post-menopause (if female).
6) Pregnancy or wish of pregnancy within six months after time of study inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To evaluate induction of the cellular immunity against HBs antigen in adult serologic non-responders after standard HBV immunization measured by IFN gamma response.;Secondary Objective: - To establish the prevalence of serologic non-response in healthy adult individuals after standard HBV immunization.<br>- To evaluate predictors of serologic non-response in healthy adult individuals after standard HBV immunization.<br>- To compare the immunologic profile in adult serologic non-responders vs adult serologic responders after standard HBV immunization<br>- To evaluate the safety of a standard HBV immunization schedule<br>;Primary end point(s): - HBsAg specific CD4+ cell IFN gamma response after standard HBV immunization<br>;Timepoint(s) of evaluation of this end point: - Two months after completed HBV immunization

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Quantitative measurement of anti-HBs antibodies after HBV immunization.<br>- Predictors of serologic non-response: age, gender, BMI, smoking status<br>- HBsAg specific cell mediated immune response: Secretion of IFN gamma, TNF alfa and IL-2 when stimulated with HBs antigen. Quantitative measures of cytokineproducing T-cells with subsequent flow cytometry. <br>- HBsAg specific T-cell proliferation<br>- T-cell phenotype analyses<br>- HBsAg- specific B-cell analyses<br>- Cytokine analyses on supernatant from HBsAg-stimulated PBMCs <br>- Safety profile: Number and severity of AE, SAE and SUSARs<br>;Timepoint(s) of evaluation of this end point: - Safety issues are evaluated after each vaccination<br>- Demographic predictors of serologic non-response at time month 0<br>- HBV serology and immune profile analyses at month 0 and 8