Kidney TransplantPhase 4EREVANCT04952766
Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults
A Phase 4 study testing Biological samples in people with Kidney Transplant and Myeloma, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial summary
The primary endpoint of this study is to compare the humoral response (titre and neutralizing capacity of induced antibodies) against SARS-CoV-2 following vaccination with BNT162b2 (Pfizer BioNTech) in immunocompromised persons, in comparison to healthy subject. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplant, Myeloma, Cancer
- What is being tested?
- Biological samples
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2021to 6 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult volunteers to be vaccinated with the ComirnatyTM vaccine and to participate in the study, belonging to one of the following groups:
- Group of immunocompromised (15 participants per immunosuppression subgroup):
- Kidney transplant
- Extracorporeal dialysis
- Solid cancer under chemotherapy and / or radiotherapy
- Myeloma under chemotherapy
Show all 16Show fewer
- Hematologic malignancies under chemotherapy
- Diseases treated with anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after)
- Multiple sclerosis under anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after)
- Common variable immune deficiency or other causes of severe hypogammaglobulinemia requiring chronic treatment with polyvalent immunoglobulin
- Malignant tumor under anti-PD1 or anti-PDL1
- People living with HIV
- Complicated type 2 diabetes (with micro and / or macroangiopathy)
- Group of non-immunocompromised subjects (controls, n = 75)
- 60 people vaccinated with the ComirnatyTM
- 15 people vaccinated with Astra Zeneca's VaxzevriaTM for the first dose
Who cannot join
- Minors
- Pregnant or breastfeeding women
- Persons under tutorship or curatorship
- Protected adults
- Person under legal protection
- Person not affiliated to a social security scheme
Show all 9Show fewer
- People with a contraindication to receiving the ComirnatyTM vaccine
- People who have already been vaccinated against SARS-CoV-2
- Note: a history of COVID-19 (> at 3 months) is not a contraindication to vaccination and is therefore not a criterion for non-inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
The primary endpoint of this study is to compare the humoral response (titre and neutralizing capacity of induced antibodies) against SARS-CoV-2 following vaccination with BNT162b2 (Pfizer BioNTech) in immunocompromised persons, in comparison to healthy subject. Secondary objectives are to evaluate the humoral response in the nasal mucosa, and the capacity of antibodies to neutralize emerging variants of concerns and to prevent COVID-19.
Read the detailed description
The serious, even fatal, forms of COVID-19 preferentially affect elderly and fragile subjects. Among these populations at risk, people who are immunocompromised (either by a disease and / or its treatment) have a theoretical risk of responding less well to a preventive vaccination.
The main objective of this study aims to compare the vaccine response of immunocompromised people with healthy subjects (non-immunocompromised), i.e. to assess the serum humoral response (titre and neutralizing capacity of the antibodies induced) following vaccination with ComirnatyTM (i.e. BNT162b2, an anti-SARS-CoV-2 vaccine from Pfizer BioNTech) in immunocompromised persons in comparison to healthy subjects (non-immunocompromised).
Secondary objectives are as follows:
- To evaluate the antibody response in the nasal mucosa (titre and neutralizing capacity of the antibodies induced, collected by means of a nasopharyngeal swab) following vaccination with ComirnatyTM in immunocompromised people as compared to healthy subjects (vaccinated either with two doses of ComirnatyTM or, in a subgroup, with one dose of Astra Zeneca's VaxzeriaTM followed by one dose of ComirnatyTM).
- Evaluate the serum and mucosal antibody response (titre and neutralizing capacity of the antibodies induced) against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains).
- Evaluate the post-vaccination clinical protection against the risk of COVID-19 infection (incident cases after vaccination).
- Conditions
- Kidney Transplant, Myeloma, Cancer, Hematologic Malignancy, Multiple Sclerosis, Hypergammaglobulinemia
- Being tested
- Biological samples
- Keywords
- SARS-CoV-2, BNT162b2 vaccine, antibody, neutralization, mucosa, immunocompromised, healthy subject
- Medical subject headings
- Neoplasms, Plasma Cell, Neoplasms, Hematologic Neoplasms, Multiple Sclerosis, Hypergammaglobulinemia, Acquired Immunodeficiency Syndrome, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological samplesBiological
Immunocompromised subjects and healthy subjects groups will have collection of biological samples (blood with/without nasopharyngeal swabs) at Month-0, -1, -2, -3, -6, with associated data for the study of the kinetics of antibodies anti COVID-19.
Biological samples :
- Serum and plasma from each participant for the purpose of performing the SARS-CoV-2 serologic tests
- Nasopharyngeal samples (not mandatory)
Associated data :
- Demographic data
- Description of clinical manifestations related to vaccination
- Description of clinical manifestations related to SARS-CoV-2 infection, if any Blood Fractioning
- Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C)
| Study group | Role | What they receive |
|---|---|---|
| immunocompromised and healthy subjects | Other | Immunocompromised subjects and healthy subjects groups will have collection of biological samples (blood with/without nasopharyngeal swabs) at Month-0, -1, -2, -3, -6, with associated data for the study of the kinetics of antibodies anti COVID-19.
Biological samples :
* Serum and plasma from each participant for the purpose of performing the SARS-CoV-2 serologic tests
* Nasopharyngeal samples (not mandatory)
Associated data :
* Demographic data
* Description of clinical manifestations related to vaccination
* Description of clinical manifestations related to SARS-CoV-2 infection, if any Blood Fractioning
* Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C) Receives: Biological: Biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective humoral response after vaccination
Proportion of immunocompromised persons with neutralizing activity against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Measured: Month 2
Secondary outcomes (15)
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Measured: Month 0
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 one month after the second dose of the vaccine, compared to the proportion obtained in healthy subjects.
Measured: Month 1
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Measured: Month 2
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Measured: Month 3
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the nasal mucosa against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
Measured: Month 6
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Measured: Month 0
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Measured: Month 1
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Measured: Month 2
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Measured: Month 3
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Proportion of immunocompromised people with neutralizing activity in the serum and nasal mucosa against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains)
Measured: Month 6
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Measured: Month 0
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Measured: Month 1
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Measured: Month 2
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Measured: Month 3
Clinical protection after vaccination
Proportion of participants developing COVID-19 infection after vaccination
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2021
- Study start26 Mar 2021
- Primary completion6 Feb 2022
- Study completion6 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants wil have at each of the 4 visits (for patients starting at month 1) or 5 visits (for patients starting at month 0): 1. a venipuncture sample of 2 dry tubes of 7 mL (less than 30 mL in total) to make up 3 aliquots and 2. a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute.
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aymeric SEVE, Dr, Principal investigator, CHU Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04952766
- Sponsor's protocol ID
- CHRO-2021-04
- Acronym
- EREVA
- Status last verified
- Dec 2025
- First submitted
- 16 Jun 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C, Guivel-Benhassine F, Staropoli I, Chazal M, Dufloo J, Planas D, Buchrieser J, Rajah MM, Robinot R, Porrot F, Albert M, Chen KY, Crescenzo-Chaigne B, Donati F, Anna F, Souque P, Gransagne M, Bellalou J, Nowakowski M, Backovic M, Bouadma L, Le Fevre L, Le Hingrat Q, Descamps D, Pourbaix A, Laouenan C, Ghosn J, Yazdanpanah Y, Besombes C, Jolly N, Pellerin-Fernandes S, Cheny O, Ungeheuer MN, Mellon G, Morel P, Rolland S, Rey FA, Behillil S, Enouf V, Lemaitre A, Creach MA, Petres S, Escriou N, Charneau P, Fontanet A, Hoen B, Bruel T, Eloit M, Mouquet H, Schwartz O, van der Werf S. A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med. 2020 Sep 2;12(559):eabc3103. doi: 10.1126/scitranslmed.abc3103. Epub 2020 Aug 17.
PubMed 32817357Planas D, Bruel T, Grzelak L, Guivel-Benhassine F, Staropoli I, Porrot F, Planchais C, Buchrieser J, Rajah MM, Bishop E, Albert M, Donati F, Prot M, Behillil S, Enouf V, Maquart M, Smati-Lafarge M, Varon E, Schortgen F, Yahyaoui L, Gonzalez M, De Seze J, Pere H, Veyer D, Seve A, Simon-Loriere E, Fafi-Kremer S, Stefic K, Mouquet H, Hocqueloux L, van der Werf S, Prazuck T, Schwartz O. Sensitivity of infectious SARS-CoV-2 B.1.1.7 and B.1.351 variants to neutralizing antibodies. Nat Med. 2021 May;27(5):917-924. doi: 10.1038/s41591-021-01318-5. Epub 2021 Mar 26.
PubMed 33772244
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating SARS-CoV-2 (COVID-19) Humoral Response After BNT162b2 Vaccine in Immunocompromised Adults Compared to Healthy Adults
- ClinicalTrials.gov ID
- NCT04952766
- Acronym / sponsor ID
- EREVA / CHRO-2021-04
- Conditions
- Kidney Transplant, Myeloma, Cancer, Hematologic Malignancy, Multiple Sclerosis, Hypergammaglobulinemia
- Keywords
- SARS-CoV-2, BNT162b2 vaccine, antibody, neutralization, mucosa, immunocompromised, healthy subject
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 6 Feb 2022 (actual)
- Study completion
- 6 Feb 2022 (actual)
- First posted
- 7 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary endpoint of this study is to compare the humoral response (titre and neutralizing capacity of induced antibodies) against SARS-CoV-2 following vaccination with BNT162b2 (Pfizer BioNTech) in immunocompromised persons, in comparison to healthy subject. Secondary objectives are to evaluate the humoral response in the nasal mucosa, and the capacity of antibodies to neutralize emerging variants of concerns and to prevent COVID-19.
Detailed description
The serious, even fatal, forms of COVID-19 preferentially affect elderly and fragile subjects. Among these populations at risk, people who are immunocompromised (either by a disease and / or its treatment) have a theoretical risk of responding less well to a preventive vaccination.
The main objective of this study aims to compare the vaccine response of immunocompromised people with healthy subjects (non-immunocompromised), i.e. to assess the serum humoral response (titre and neutralizing capacity of the antibodies induced) following vaccination with ComirnatyTM (i.e. BNT162b2, an anti-SARS-CoV-2 vaccine from Pfizer BioNTech) in immunocompromised persons in comparison to healthy subjects (non-immunocompromised).
Secondary objectives are as follows:
- To evaluate the antibody response in the nasal mucosa (titre and neutralizing capacity of the antibodies induced, collected by means of a nasopharyngeal swab) following vaccination with ComirnatyTM in immunocompromised people as compared to healthy subjects (vaccinated either with two doses of ComirnatyTM or, in a subgroup, with one dose of Astra Zeneca's VaxzeriaTM followed by one dose of ComirnatyTM).
- Evaluate the serum and mucosal antibody response (titre and neutralizing capacity of the antibodies induced) against emerging strains of SARS-CoV-2 (so-called Alpha, Beta, Gamma, Delta strains).
- Evaluate the post-vaccination clinical protection against the risk of COVID-19 infection (incident cases after vaccination).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants wil have at each of the 4 visits (for patients starting at month 1) or 5 visits (for patients starting at month 0): 1. a venipuncture sample of 2 dry tubes of 7 mL (less than 30 mL in total) to make up 3 aliquots and 2. a nasopharyngeal swab (optional). The aliquots of serum / plasma and the nasopharyngeal swab will be stored at -80°C until sent to the Pasteur Institute.
| Arm | Type | Receives |
|---|---|---|
| immunocompromised and healthy subjects | Other | Biological: Biological samplesImmunocompromised subjects and healthy subjects groups will have collection of biological samples (blood with/without nasopharyngeal swabs) at Month-0, -1, -2, -3, -6, with associated data for the study of the kinetics of antibodies anti COVID-19. Biological samples : * Serum and plasma from each participant for the purpose of performing the SARS-CoV-2 serologic tests * Nasopharyngeal samples (not mandatory) Associated data : * Demographic data * Description of clinical manifestations related to vaccination * Description of clinical manifestations related to SARS-CoV-2 infection, if any Blood Fractioning * Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Adult volunteers to be vaccinated with the ComirnatyTM vaccine and to participate in the study, belonging to one of the following groups:
Key exclusion criteria (9 listed)
- Minors
- Pregnant or breastfeeding women
- Persons under tutorship or curatorship
- Protected adults
- Person under legal protection
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 |
|---|---|---|
| Biological samplesImmunocompromised subjects and healthy subjects groups will have collection of biological samples (blood with/without nasopharyngeal swabs) at Month-0, -1, -2, -3, -6, with associated data for the study of the kinetics of antibodies anti COVID-19. Biological samples : * Serum and plasma from each participant for the purpose of performing the SARS-CoV-2 serologic tests * Nasopharyngeal samples (not mandatory) Associated data : * Demographic data * Description of clinical manifestations related to vaccination * Description of clinical manifestations related to SARS-CoV-2 infection, if any Blood Fractioning * Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C) | Biological | immunocompromised and healthy subjects |
Primary outcome
Protective humoral response after vaccination
Time frame: Month 2
Proportion of immunocompromised persons with neutralizing activity against the classic "Wuhan" strain of SARS-CoV-2 compared to the proportion obtained in healthy subjects.
15 secondary outcomes
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time frame: Month 0
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time frame: Month 1
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time frame: Month 2
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time frame: Month 3
Mucosal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time frame: Month 6
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time frame: Month 0
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time frame: Month 1
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time frame: Month 2
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time frame: Month 3
Serum and nasal neutralization capacity against wild-type and emerging variants of concern (VOC)
Time frame: Month 6
Clinical protection after vaccination
Time frame: Month 0
Clinical protection after vaccination
Time frame: Month 1
Clinical protection after vaccination
Time frame: Month 2
Clinical protection after vaccination
Time frame: Month 3
Clinical protection after vaccination
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 32817357Grzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C, Guivel-Benhassine F, Staropoli I, Chazal M, Dufloo J, Planas D, Buchrieser J, Rajah MM, Robinot R, Porrot F, Albert M, Chen KY, Crescenzo-Chaigne B, Donati F, Anna F, Souque P, Gransagne M, Bellalou J, Nowakowski M, Backovic M, Bouadma L, Le Fevre L, Le Hingrat Q, Descamps D, Pourbaix A, Laouenan C, Ghosn J, Yazdanpanah Y, Besombes C, Jolly N, Pellerin-Fernandes S, Cheny O, Ungeheuer MN, Mellon G, Morel P, Rolland S, Rey FA, Behillil S, Enouf V, Lemaitre A, Creach MA, Petres S, Escriou N, Charneau P, Fontanet A, Hoen B, Bruel T, Eloit M, Mouquet H, Schwartz O, van der Werf S. A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med. 2020 Sep 2;12(559):eabc3103. doi: 10.1126/scitranslmed.abc3103. Epub 2020 Aug 17.
- Background: PubMed 33772244Planas D, Bruel T, Grzelak L, Guivel-Benhassine F, Staropoli I, Porrot F, Planchais C, Buchrieser J, Rajah MM, Bishop E, Albert M, Donati F, Prot M, Behillil S, Enouf V, Maquart M, Smati-Lafarge M, Varon E, Schortgen F, Yahyaoui L, Gonzalez M, De Seze J, Pere H, Veyer D, Seve A, Simon-Loriere E, Fafi-Kremer S, Stefic K, Mouquet H, Hocqueloux L, van der Werf S, Prazuck T, Schwartz O. Sensitivity of infectious SARS-CoV-2 B.1.1.7 and B.1.351 variants to neutralizing antibodies. Nat Med. 2021 May;27(5):917-924. doi: 10.1038/s41591-021-01318-5. Epub 2021 Mar 26.
- Individual participant dataSharing planned: No
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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.
Aymeric SEVE, Dr principal investigator
CHU Orléans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Biological samples in people with Kidney Transplant and Myeloma, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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 16 inclusion and 9 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Protective humoral response after vaccination (time frame: Month 2). 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 NCT04952766, which also lists 2 linked publications.
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 23 Dec 2025.