E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with IgG-deficiency |
Patienter med IgG-brist |
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E.1.1.1 | Medical condition in easily understood language |
Patients with IgG-deficiency |
Patienter med IgG-brist |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
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 study opsonizing IgG after vaccination with a conjugated pneumococcal vaccine given to patients with IgG-deficiency. |
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E.2.2 | Secondary objectives of the trial |
To study cellular immune responses after vaccination with a conjugated pneumococcal vaccine given to patients with IgG-deficiency. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. The patients should have been diagnosed with IgG-deficiency; IgG1<2.8 g/l and/or IgG2<1.15 g/L.
2. The patient should be between 18-65 years of age
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E.4 | Principal exclusion criteria |
1. The patient should not have been given Prevenar 7 or 13 prior to the study inclusion.
2. The patient should not have been given PPV23 2 years prior to the study inclusion.
3. The patient should not be pregnant.
4. The patient should not take part in any other clinical study involving drugs or vaccines.
The healthy controls should be healthy and not be on any drugs that could interfere with an immune response (systemic steroids, NSAIDs, immunosuppressive drugs).
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E.5 End points |
E.5.1 | Primary end point(s) |
Opsonophagocytic activity of pre- and postvaccination titers, respectively. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
We will compare titer after 4 weeks with baseline, but will also evaluate titers after 1 and 2 weeks post vaccination. |
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E.5.2 | Secondary end point(s) |
Cellular immune-responses against penumococcal vaccine strains. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The cellular immune response will be evaluated at time=0, 1 week, 2 weeks and 4 weeks, where the secondary endpoint is the difference between baseline and 4 weeks. |
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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 | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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 | No |
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 | No |
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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The end of the clinical trial is defined as when the last person has left samples at week=4. The analysis part will continue at least 1 year after this timepoint. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |