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 | 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 |
• Assess the magnitude of systemic antibody responses to the SARS-CoV-2 vaccine in 64-90 years old male and female persons at a month after completion of SARS-CoV-2 vaccination. • To address the magnitude and quality of T-cell and B-cell immune responses induced by the current new SARS-CoV-2 vaccines at a month after completion of SARS-CoV-2 vaccination in older male and female persons (64-90 years of age).
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E.2.2 | Secondary objectives of the trial |
• Monitoring of kinetics and longevity of antibody and cellular responses induced by SARS-CoV-2 vaccination. • Measuring vaccine-induced antibody capacity for (pseudo)neutralization of circulating SARS-CoV-2 subvariants, either dominant genotype or future mutations. • Measuring the (IgA and IgG) antibody response in the nasal mucosal lining fluid and/or saliva, induced by SARS-CoV-2 vaccines. • Assess possible interference of infection with SARS-CoV-2 with antibody responses and B end Tcell responsiveness as well , by measuring virus-specific serum IgG antibodies to SARS-CoV-2 Core N protein and using data on the results of PCR testing and from questionnaires. • Assess the relation of age and frailty index of older male and female persons with all immune responses to SARS-CoV-2.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Having participated the ISA study (part of the DCS). • Willing to receive the SARS-CoV-2 vaccine. • Willing to give the Informed Consent.
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E.4 | Principal exclusion criteria |
A potential subject will be excluded from participation in this study when a person already received the last SARS-CoV-2 vaccination more than a month earlier and has not signed the ICF at T0, T1 or T2 . |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Specific serum IgG antibody concentrations at one month after the second vaccination. Serum samples will be tested for the presence and concentration of SARS-CoV-2 specific antibodies by quantitative multiplex serology (21). • Frequencies of of the adaptive memory B-cell responses and functional T-cell responses at one month after the second SARS-CoV-2 vaccination will be measured.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1 month post last vaccination. |
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E.5.2 | Secondary end point(s) |
1 Longevity of antibody levels and cellular responses as described above will be determined at 1 year post vaccination (T4) 2 IgG antibody titers to other coronaviruses will be measured by bead-based multiplex immuno assay at T0, T3 and T4. 3 Selected SARS-CoV-2 positive serum samples will be tested for antibody binding strength (avidity) and virus neutralization, providing a functional measure of immune protection at 1 month (T1) (T2), 6 months (T3) and 1 year (T4) post vaccination 4 Mucosal IgA and IgG antibodies will be determined in nose fluids or saliva by bead-based multiplex immuno assay at T2 and T4. 5 IgG antibodies to the SARS-CoV-2 core N protein indicating contact with the virus will be determined by the MIA assay as described 6 Self-reported experiences possible SARS-CoV-2 infection from answers to a short questionnaires. 7 Integrated endpoint analysis of all antibody analysis with age, sex and frailty data.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.1 year after last vaccination 2. pre and 6 and 12 months post last vaccination. 3. 1 month after first vaccination, 6 and 12 months post last vaccination. 4. 1 month an 1 year post last vaccination
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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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Immune response to SARS-CoV-2 vaccines. |
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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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |