Healthy individuals MedDRA version: 13.1 Level: PT Classification code 10060023 Term: Interferon gamma level System Organ Class: 10022891 - Investigations MedDRA version: 13.1 Level: PT Classification code 10054130 Term: Hepatitis B immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Twinrix Voksen
Product Name: Twinrix Voksen
Pharmaceutical Form: Suspension for injection
Other descriptive name: HEPATITIS A (INACTIVATED) AND HEPATITIS B (RDNA) VACCINE (ADSORBED)
Concen
Sponsors
Lars Jørgen Østergaard
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - To evaluate predictors of serologic non-response in healthy adult individuals after standard HBV immunization. - To compare the immunologic profile in adult serologic non-responders vs adult serologic responders after standard HBV immunization - To evaluate the safety of a standard HBV immunization schedule ;Primary end point(s): - HBsAg specific CD4+ cell IFN gamma response after standard HBV immunization ;Timepoint(s) of evaluation of this end point: - Two months after completed HBV immunization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Quantitative measurement of anti-HBs antibodies after HBV immunization. - Predictors of serologic non-response: age, gender, BMI, smoking status - 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. - HBsAg specific T-cell proliferation - T-cell phenotype analyses - HBsAg- specific B-cell analyses - Cytokine analyses on supernatant from HBsAg-stimulated PBMCs - Safety profile: Number and severity of AE, SAE and SUSARs ;Timepoint(s) of evaluation of this end point: - Safety issues are evaluated after each vaccination - Demographic predictors of serologic non-response at time month 0 - HBV serology and immune profile analyses at month 0 and 8 | — |
Countries
Denmark
Contacts
Public ContactLars Jørgen Østergaard
Lars Jørgen Østergaard
Outcome results
None listed