Prevention of COVID-19Phase 2EU-COVAT-1NCT05160766
Assessing Immune Response of Different COVID-19 Vaccines in Older Adults
A Phase 2 study testing Comirnaty (BTN162b2) and Spikevax (mRNA-1273) in people with Prevention of COVID-19, run by Oliver Cornely, MD at 9 sites in 4 countries.
Trial summary
This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prevention of COVID-19
- What is being tested?
- Comirnaty (BTN162b2) and Spikevax (mRNA-1273)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 8 Nov 2021to 13 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Subject is ≥75 years old.
- Prior to study entry the subject was vaccinated with BNT162b2, mRNA-1273 or ChAdOx-1-S (same vaccine product for 1st + 2nd dose)
- BNT162b2 + BNT162b2
- mRNA-1273 + mRNA-1273
- ChAdOx-1-S + ChAdOx-1-S
- 9 ± 3 months since the second vaccine dose at time of enrolment for the planned 3rd vaccine dose in the trial. Vaccination status should be documented in the source data and captured in the eCRF.
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- No contra-indication against any of the vaccine products in the trial.
- Written informed consent from subject has been obtained.
- Subject is ≥75 years old.
- Prior to study entry the subject was vaccinated with one of the following vaccination regimens (1st + 2nd + 3rd dose):
- BNT162b2 + BNT162b2 + BNT162b2
- BNT162b2 + BNT162b2 + mRNA-1273
- mRNA-1273 + mRNA-1273 + mRNA-1273
- mRNA-1273 + mRNA-1273 + BNT162b2
- ChAdOx-1-S + ChAdOx-1-S + BNT162b2
- ChAdOx-1-S + ChAdOx-1-S + mRNA-1273
- The last dose of the above listed vaccinations must have been administered at least 1 month prior to study entry. Vaccination status should be documented in the source data and will be captured in the eCRF.
- Written informed consent from subject has been obtained.
Who cannot join
- Primary vaccination performed with different vaccine products as sole (e.g., COVID-19 Vaccine Janssen) or, 1st and 2nd vaccination doses (heterologous vaccination scheme).
- Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator.
- Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to >10 mg/day prednisolone.
- Participation in other interventional trials.
- Subjects unable to report solicited adverse events.
- Subject with any contraindications to the vaccines in the trial at randomisation. A list of contraindications as listed in the Summary of medicinal Product Characteristics (SmPC, the Fachinformation in Germany), if appropriate.
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- Use of drugs with significant interaction with the investigational product according to the SmPC or similar documents.
- Diseases or findings that may have a significant effect on the target variables and which may therefore mask or inhibit the therapeutic effect under investigation.
- Any current SARS-CoV-2 infection or proven in the preceding 3 months.
- Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator.
- Legally incapacitated persons.
- Persons held in an institution by legal or official order.
- Prior to study entry the subject got vaccinated with a regimen not included in the list given above.
- Last anti-SARS-CoV-2 vaccine dose administered less than one month prior to study entry.
- Vaccination against a disease other than COVID-19 within 2 weeks prior to study entry. Only exception: Influenza vaccination which is allowed at any time.
- Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator.
- Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to >10 mg/day prednisolone.
- Subject simultaneously participates in another clinical trials or has participated in the past 30 days.
- Subjects unable to report solicited adverse events.
- Subject with any contraindications to the vaccines in the trial. A list of contraindications as listed in the Summary of medicinal Product Characteristics (SmPC, the Fachinformation in Germany), if appropriate.
Trial locations and contacts
9 sites in 4 countries.
9 sites in 4 countries
Spain4 sites
Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Reina Sofia University Hospital
Córdoba, 14004
La Paz University Hospital
Madrid, 28046
Biodonostia Health Research Institute
San Sebastián, 20014
Germany3 sites
University Hospital Cologne
Cologne, 50931
University Hospital Frankfurt
Frankfurt, 60590
Hannover Medical School Hospital
Hanover, 30625
Lithuania1 site
Vilnius University Hospital Santaros Klinikos
Vilnius, 08661
About this study
Official title: A Multinational, Phase 2, Randomised, Adaptive Protocol to Evaluate Immunogenicity and Reactogenicity of Different COVID-19 Vaccines Administration in Older Adults (≥75) Already Vaccinated Against SARS-COV-2 (EU-COVAT-1_AGED)
This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2.
Part A of this trial foresees testing of different vaccines as a 3rd vaccination dose (first booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants in the elderly, a usually neglected population.
Part B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV-2 wild-type and variants in the identical population.
Read the detailed description
Part A of the present trial in which individuals received a 3rd vaccination (first booster) of either BNT162b2 or mRNA-1273 was closed to further recruitment as of January 13, 2022. This was due to a change in vaccination policies, recommending a 3rd vaccination with either BNT162b2 or mRNA-1273. Therefore, Part A was supplanted by Part B that investigated a 4th COVID-19 vaccination and started on 21 Jan 2022.
The initial study protocol started the trial with Part A in which participants were randomized to a 3rd vaccination (first booster) with either BNT162b2 or mRNA-1273:
Subjects who - prior to study entry - received a vaccination series of either BNT162b2 \& BNT162b2 or mRNA-1273 \& mRNA-1273 or ChAdOx-1-S \& ChAdOx-1-S.
For the reasons mentioned above, the study protocol was amended to continue the trial with Part B in which participants were randomized to a 4th vaccination (second booster) with either BNT162b2 or mRNA-1273:
Subjects who - prior to study entry - received a vaccination series of either BNT162b2 \& BNT162b2 \& BNT162b2 or BNT162b2 \& BNT162b2 \& mRNA-1273 or mRNA-1273 \& mRNA-1273 \& mRNA-1273 or mRNA-1273 \& mRNA-1273 \& BNT162b2 or ChAdOx-1-S \& ChAdOx-1-S \& BNT162b2 or ChAdOx-1-S \& ChAdOx-1-S \& mRNA-1273.
- Conditions
- Prevention of COVID-19
- Being tested
- Comirnaty (BTN162b2), Spikevax (mRNA-1273)
- Keywords
- SARS-CoV-2, COVID-19, Vaccination, Immunogenicity, BNT162b2, mRNA-1273, Booster, Elderly, head-to-head comparison
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comirnaty (BTN162b2)Biological
Single booster shot (3rd dose in Part A and 4th dose in Part B)
Spikevax (mRNA-1273)Biological
Single booster shot (3rd dose in Part A and 4th dose in Part B)
| Study group | Role | What they receive |
|---|---|---|
| BNT162b2 (Part A) | Active comparator | vaccination with BNT162b2 as 3rd vaccination Receives: Biological: Comirnaty (BTN162b2) |
| mRNA-1273 (Part A) | Active comparator | vaccination with mRNA-1273 as 3rd vaccination Receives: Biological: Spikevax (mRNA-1273) |
| BNT162b2 (Part B) | Active comparator | vaccination with BNT162b2 as 4th vaccination Receives: Biological: Comirnaty (BTN162b2) |
| mRNA-1273 (Part B) | Active comparator | vaccination with mRNA-1273 as 4th vaccination Receives: Biological: Spikevax (mRNA-1273) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody Titre Increase 14 Days After Study Vaccination Dose.
Rate of 2-fold antibody titre increase 14 days after 3rd (Part A) or 4th vaccination dose (Part B) measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus.
Measured: From Day 0 until Day 14
Secondary outcomes (5)
Change in Neutralizing Antibody Titre Against Wild-type 14 Days After Study Vaccination Dose
Change in neutralizing antibody titre (Virus Neutralisation Assay) against wild-type 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.
Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities.
Measured: From Day 0 until Day 14
Change in Neutralizing Antibody Titre Against Variants of Concern 14 Days After Study Vaccination Dose
Change in neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern 14 days after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.
Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities.
Measured: From Day 0 until Day 14
Antibody Titre Level at 12 Months After a Study Vaccination Dose
Antibody titre level at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B) measured by a quantitative enzyme-linked immunosorbent assay (anti-RBD-ELISA assay).
Measured: From Day 0 until Month 12
Neutralizing Antibody Titre Against Wild-type at 12 Months After Study Vaccination Dose
Neutralizing antibody titre (Virus Neutralisation Assay) against wild-type SARS-CoV-2 at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.
Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities.
Measured: From Day 0 until Month 12
Neutralizing Antibody Titre Against Variants of Concern at 12 Months After Study Vaccination Dose
Neutralizing antibody titre (Virus Neutralisation Assay) against variants of concern at 12 months after a 3rd (Part A) or 4th vaccination dose (Part B), to be determined in a subgroup only.
Microneutralization assay results were proposed to be reported as "change in neutralizing antibody titre (Virus Neutralisation Assay)" in the trial protocol. However, as the pandemic progressed, the need arose to assess neutralization against different variants. In our stud(ies), we evaluated not only the Wuhan strain but also 25 distinct variants of concern (VoCs) and/or variants of interest (VoIs). For VoCs and VoIs, expressing results as "change in neutralization capacity expressed as a percentage (%)" is more effective as it illustrates the impact of mutations on neutralization, thereby allowing cross-variant comparisons. This adjustment did not alter the suggested endpoint, as both reporting methods reflect the ability of patients' antibodies neutralizing capacities.
Measured: From Day 0 until Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start8 Nov 2021
- Primary completion1 Oct 2022
- Study completion13 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. This trial foresees testing of different vaccines as a third (first booster, Part A) or fourth vaccine dose (second booster, Part B) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 and SARS-CoV-2 variants in the elderly.
- Masking
- None (open label)
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oliver Cornely, MD
- Sponsor type
- University, hospital or other
- Collaborators
- VACCELERATE, European Commission
- Responsible party
- Sponsor-investigator, Oliver Cornely, MD, University of Cologne
- Investigators
- Oliver A Cornely, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160766
- Sponsor's protocol ID
- EU-COVAT-1_AGED
- Other IDs
- 2021-004526-29, uni-koeln-4602
- Acronym
- EU-COVAT-1
- Status last verified
- May 2025
- First submitted
- 11 Nov 2021
- Last updated
- 20 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Making de-identified/anonymized data accessible is currently under way. We expect to grant access through a central independent data repository no later than January 2025. Any pertinent information will be updated in due course.
Publications
Neuhann JM, Stemler J, Carcas A, Frias-Iniesta J, Bethe U, Heringer S, Tischmann L, Zarrouk M, Cuppers A, Konig F, Posch M, Cornely OA. A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults >/=75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network. Trials. 2022 Oct 8;23(1):865. doi: 10.1186/s13063-022-06791-y.
PubMed 36209129
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational, Phase 2, Randomised, Adaptive Protocol to Evaluate Immunogenicity and Reactogenicity of Different COVID-19 Vaccines Administration in Older Adults (≥75) Already Vaccinated Against SARS-COV-2 (EU-COVAT-1_AGED)
- ClinicalTrials.gov ID
- NCT05160766
- Acronym / sponsor ID
- EU-COVAT-1 / EU-COVAT-1_AGED
- Conditions
- Prevention of COVID-19
- Keywords
- SARS-CoV-2, COVID-19, Vaccination, Immunogenicity, BNT162b2, mRNA-1273, Booster, Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Oliver Cornely, MDUniversity, hospital or other
- Collaborators
- VACCELERATE, European Commission
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 13 Sep 2023 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Posted 20 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2.
Part A of this trial foresees testing of different vaccines as a 3rd vaccination dose (first booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants in the elderly, a usually neglected population.
Part B of this trial foresees testing of different vaccines as a 4th vaccination dose (second booster) for comparative assessment of their immunogenicity and safety against SARSCoV-2 wild-type and variants in the identical population.
Detailed description
Part A of the present trial in which individuals received a 3rd vaccination (first booster) of either BNT162b2 or mRNA-1273 was closed to further recruitment as of January 13, 2022. This was due to a change in vaccination policies, recommending a 3rd vaccination with either BNT162b2 or mRNA-1273. Therefore, Part A was supplanted by Part B that investigated a 4th COVID-19 vaccination and started on 21 Jan 2022.
The initial study protocol started the trial with Part A in which participants were randomized to a 3rd vaccination (first booster) with either BNT162b2 or mRNA-1273:
Subjects who - prior to study entry - received a vaccination series of either BNT162b2 \& BNT162b2 or mRNA-1273 \& mRNA-1273 or ChAdOx-1-S \& ChAdOx-1-S.
For the reasons mentioned above, the study protocol was amended to continue the trial with Part B in which participants were randomized to a 4th vaccination (second booster) with either BNT162b2 or mRNA-1273:
Subjects who - prior to study entry - received a vaccination series of either BNT162b2 \& BNT162b2 \& BNT162b2 or BNT162b2 \& BNT162b2 \& mRNA-1273 or mRNA-1273 \& mRNA-1273 \& mRNA-1273 or mRNA-1273 \& mRNA-1273 \& BNT162b2 or ChAdOx-1-S \& ChAdOx-1-S \& BNT162b2 or ChAdOx-1-S \& ChAdOx-1-S \& mRNA-1273.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This is a randomised controlled, adaptive, multicentre Phase II protocol evaluating different booster strategies in individuals aged 75 years and older already vaccinated against SARS-CoV-2. This trial foresees testing of different vaccines as a third (first booster, Part A) or fourth vaccine dose (second booster, Part B) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 and SARS-CoV-2 variants in the elderly.
| Arm | Type | Receives |
|---|---|---|
| BNT162b2 (Part A) | Active comparator | Biological: Comirnaty (BTN162b2)vaccination with BNT162b2 as 3rd vaccination |
| mRNA-1273 (Part A) | Active comparator | Biological: Spikevax (mRNA-1273)vaccination with mRNA-1273 as 3rd vaccination |
| BNT162b2 (Part B) | Active comparator | Biological: Comirnaty (BTN162b2)vaccination with BNT162b2 as 4th vaccination |
| mRNA-1273 (Part B) | Active comparator | Biological: Spikevax (mRNA-1273)vaccination with mRNA-1273 as 4th vaccination |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (18 listed)
- Subject is ≥75 years old.
- Prior to study entry the subject was vaccinated with BNT162b2, mRNA-1273 or ChAdOx-1-S (same vaccine product for 1st + 2nd dose)
- BNT162b2 + BNT162b2
- mRNA-1273 + mRNA-1273
- ChAdOx-1-S + ChAdOx-1-S
Key exclusion criteria (20 listed)
- Primary vaccination performed with different vaccine products as sole (e.g., COVID-19 Vaccine Janssen) or, 1st and 2nd vaccination doses (heterologous vaccination scheme).
- Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator.
- Current immunosuppressive therapy, for example continuous glucocorticosteroid treatment equivalent to >10 mg/day prednisolone.
- Participation in other interventional trials.
- Subjects unable to report solicited adverse events.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comirnaty (BTN162b2)Single booster shot (3rd dose in Part A and 4th dose in Part B) | Biological | BNT162b2 (Part A), BNT162b2 (Part B) |
| Spikevax (mRNA-1273)Single booster shot (3rd dose in Part A and 4th dose in Part B) | Biological | mRNA-1273 (Part A), mRNA-1273 (Part B) |
Primary outcome
Antibody Titre Increase 14 Days After Study Vaccination Dose.
Time frame: From Day 0 until Day 14
Rate of 2-fold antibody titre increase 14 days after 3rd (Part A) or 4th vaccination dose (Part B) measured by qualitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus.
5 secondary outcomes
Change in Neutralizing Antibody Titre Against Wild-type 14 Days After Study Vaccination Dose
Time frame: From Day 0 until Day 14
Change in Neutralizing Antibody Titre Against Variants of Concern 14 Days After Study Vaccination Dose
Time frame: From Day 0 until Day 14
Antibody Titre Level at 12 Months After a Study Vaccination Dose
Time frame: From Day 0 until Month 12
Neutralizing Antibody Titre Against Wild-type at 12 Months After Study Vaccination Dose
Time frame: From Day 0 until Month 12
Neutralizing Antibody Titre Against Variants of Concern at 12 Months After Study Vaccination Dose
Time frame: From Day 0 until Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36209129Neuhann JM, Stemler J, Carcas A, Frias-Iniesta J, Bethe U, Heringer S, Tischmann L, Zarrouk M, Cuppers A, Konig F, Posch M, Cornely OA. A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults >/=75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network. Trials. 2022 Oct 8;23(1):865. doi: 10.1186/s13063-022-06791-y.
- Individual participant dataSharing planned: Yes. Making de-identified/anonymized data accessible is currently under way. We expect to grant access through a central independent data repository no later than January 2025. Any pertinent information will be updated in due course.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver A Cornely, MD principal investigator
University of Cologne
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comirnaty (BTN162b2) and Spikevax (mRNA-1273) in people with Prevention of COVID-19, run by Oliver Cornely, MD at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Germany, Lithuania, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody Titre Increase 14 Days After Study Vaccination Dose. (time frame: From Day 0 until Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05160766, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.