E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060023 |
E.1.2 | Term | Interferon gamma level |
E.1.2 | System Organ Class | 10022891 - Investigations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10054130 |
E.1.2 | Term | Hepatitis B immunisation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To evaluate induction of the cellular immunity against HBs antigen in adult serologic non-responders after standard HBV immunization measured by IFN gamma response. |
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E.2.2 | Secondary objectives of the trial |
- 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
- HBsAg specific CD4+ cell IFN gamma response after standard HBV immunization
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Two months after completed HBV immunization |
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E.5.2 | 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
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
no comparison of drugs, but comparison of serologic responders and serologic non-responders |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |