E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Covid (Coronavirus disease)- 19 immunisation |
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E.1.1.1 | Medical condition in easily understood language |
Coronavirus disease vaccination |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10084457 |
E.1.2 | Term | COVID-19 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 |
Quantitative and functional comparison of the salivary anti-SARS-CoV-2 antibody response before and after 3rd booster vaccination. |
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E.2.2 | Secondary objectives of the trial |
To answer the following research questions: 1. Is there a difference in concentration and persistence of salivary antibodies between the various primary vaccines before and after the 3rd booster vaccination? 2. Is there any difference in the neutralizing capacity of salivary antibodies between the various primary vaccines before and after the 3rd booster vaccination towards the various SARS-CoV-2 variants? 3. Do saliva and serum antibody levels correlate? Is saliva a possible surrogate sample to monitor the antibody response to COVID vaccines? 4. How does the neutralizing capacity of saliva and serum antibodies compare? 5. Are different salivary antibody profiles in terms of quantity and subclasses associated with previous exposure to other respiratory pathogens including endemic coronaviruses? 6. Is a difference in the T cell response associated with different antibody profiles in saliva and serum? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet the following inclusion criteria:
1. Healthy Individuals who received full vaccination with any authorized COVID-19 vaccine and decided to receive a booster vaccination as recommended by national guidelines. |
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E.4 | Principal exclusion criteria |
1. Presence of diseases or therapies that are likely to interfere with the immune response to booster vaccination. 2. Any contraindications to the vaccine planned to receive as listed in the product characteristics. 3. Lack of willingness to undergo serial blood draws and attend follow-up appointments. 4. Having already received a third (booster) vaccination with any COVID-19 vaccine. 5. Women who are pregnant or breastfeeding. 6. Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent) |
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E.5 End points |
E.5.1 | Primary end point(s) |
IgA, IgG and IgM concentrations to anti-SARS-CoV-2 spike protein in saliva and serum before the third booster vaccination and 3-8 weeks and 6 months after the third booster vaccination, measured by SARS-CoV-2 antigen-binding Ig assays and life virus and pseudovirus neutralizing assays. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Before the third booster vaccination, 3-8 weeks, and 6 months after the third booster vaccination |
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E.5.2 | Secondary end point(s) |
• IgA, IgG and IgM concentrations to anti-SARS-CoV-2 spike protein in serum before the third booster vaccination and 3-8 weeks after the third booster vaccination • IgA, IgG and IgM concentrations to anti-SARS-CoV-2 spike protein in saliva and serum before the third booster vaccination and 6 months after the third booster vaccination • Reactivity of recombinant S protein-specific T cells before the third booster vaccination and 3-8 weeks and 6 months after the third booster vaccination. • Detection of antibodies against other respiratory pathogens including endemic coronaviruses which might be associated with the response to booster COVID-19 vaccinations |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before the third booster vaccination, 3-8 weeks, and 6 months after the third booster vaccination |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
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 | 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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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 | 15 |
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 | 15 |
E.8.9.2 | In all countries concerned by the trial days | 0 |