Certain Disorders Involving the Immune MechanismMUCOVIDNCT06142279
Development and Qualification of Methods for Analyzing the Mucosal Immune Response to COVID-19
A study testing Sampling and PCR (polymerase chain reaction) SARS-CoV-2 in people with Certain Disorders Involving the Immune Mechanism, run by University Hospital, Tours at 1 site in France.
Trial summary
The pandemic associated with the SARS-CoV-2 coronavirus has affected over 760 million individuals worldwide, resulting in more than 6.9 million deaths. France has also been heavily impacted, with over 39.8 million infections and 167,000 deaths. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Certain Disorders Involving the Immune Mechanism
- What is being tested?
- Sampling and PCR (polymerase chain reaction) SARS-CoV-2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2023to Nov 2024
- Phase
- Interventional
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old
- Participant affiliated with a social security scheme
- Participant willing to take part in the study and having provided consent
- Participant in good health or with a stable chronic condition for more than 6 months
Who cannot join
- Contraindication for nasopharyngeal sampling
- Pregnant or breastfeeding women
- Participants benefiting from a legal protection measure as referred to in articles L1121-5 to L1121-8 of the Public Health Code (guardianship, trusteeship, etc.)
- Participant with an acute condition unrelated to SARS-CoV-2 infection
- Participant with an unstable chronic condition
Trial locations and contacts
1 site in 1 country.
France1 site
CHRU de Tours
Tours, 37044
Zoha MAAKAROUN-VERMESSE, MD-PHD, 0247476972 ext. Investigator, Z.MAAKAROUN-VERMESSE@chu-tours.fr
About this study
The pandemic associated with the SARS-CoV-2 coronavirus has affected over 760 million individuals worldwide, resulting in more than 6.9 million deaths. France has also been heavily impacted, with over 39.8 million infections and 167,000 deaths.
SARS-CoV-2 primarily causes an upper respiratory tract infection transmitted through the air. When it reaches the lungs, it leads to a severe acute respiratory illness called COVID-19. The body's response to this viral assault primarily occurs at the level of the respiratory mucosa.
Read more
This mucosal response is complex, involving various levels of activity. Mucosal immunity is therefore essential for an adequate and long-term immune response against viral respiratory infections, including SARS-CoV-2 infection.
Infection with SARS-CoV-2 triggers a humoral immune response with the production of antibodies in the blood (serum antibodies) and antibodies in the upper respiratory tract (mucosal antibodies). It also induces a cellular immune response by activating specific blood T lymphocytes.
Tests used to measure the humoral blood response against SARS-CoV-2 and their neutralizing capacity are now well identified, as are tests for assessing the serum cellular T lymphocyte response. However, tests for measuring mucosal immune responses are not routinely used.
Our study aims to develop and qualify methods for analyzing mucosal immunity directed against SARS-CoV-2. These methods will be essential for a more precise analysis of the body's mucosal response to this virus.
Once these analytical methods are validated, they will enable the study of mucosal responses to infection, as well as mucosal responses induced by vaccination against SARS-CoV-2, particularly in the context of future nasal vaccine use.
Read the detailed description
SARS-CoV-2 is initially responsible for an airborne infection of the upper respiratory tract which, on reaching the lungs, causes a severe acute respiratory illness known as COVID-19.
The organism's response to this viral aggression is initially directed at the respiratory mucosa.
This mucosal response is complex, with different levels of activity interacting: mechanical activity, with the secretion of mucus that acts as a barrier to the infectious agent; physico-chemical activity, with the production of enzymes and cytokines that contribute to the degradation of viral particles; and specific humoral immune activity, with the production of secretory IgA-type immunoglobulins at the mucosal level, with neutralizing activity that blocks viral entry into the host cell.
These innate and adaptive immune mechanisms, together with their humoral and cellular components, play an essential role in mucosal barrier function. Mucosal immunity is therefore essential for an adequate, early and long-term immune response against respiratory viral infections.
SARS-CoV-2 is an enveloped virus with a helical capsid and a genome consisting of approximately 30,000 nucleotides. This genome codes for several proteins essential for virion formation, including the S protein for Spike and the N protein for nucleocapsid.
The viral S protein binds to the host cell's angiotensin-converting enzyme 2 (ACE2). ACE2 thus acts as a viral receptor mediating viral entry into the cell and the triggering an immune response in the host. This protein S is the main target of the neutralizing antibody response. Mutations in protein S have been responsible for the emergence of variants of SARS-CoV-2 with different phenotypes affecting transmission and susceptibility to antibody.
The N protein is a highly immunogenic glycoprotein also involved in viral replication and in the modulation of cellular signalling pathways. During virion assembly virion, the N protein binds to viral RNA and leads to the formation of the helical nucleocapsid. This N protein is highly conserved in all SARS-CoV-2 variants and may therefore be an interesting target in the universal defense against this virus.
In the event of a respiratory infection, stimulation of the mucosal immune system triggers on the one hand, a humoral response with the release of secretory immunoglobulins, mainly secretory IgA. The main role of IgA is to prevent the virus from spreading throughout the body.
On the other hand, respiratory infection will also trigger a mucosal cellular response primarily mediated by T lymphocytes.
Infection with SARS-CoV-2 triggers an immune response involving antibody production in the blood (serum antibodies), stimulation of blood lymphocytes and antibody production in the upper respiratory tract (mucosal antibodies). The quantitative anti-SARS-CoV-2 humoral response in the blood (serum antibodies) has been assessed by various tests. For the time being, however, it relies mainly on EIA-type tests, with blood levels of anti-S IgG (directed against the Spike protein) and anti-N IgG (directed against the nucleocapsid protein). Qualitative analysis of this response is based on the ability of these antibodies to have neutralizing activity (neutralizing antibodies).
The anti-SARS-CoV-2 T lymphocyte cellular response also appears to be important in controlling infection. The most rapid test for assessing this T lymphocyte response is the ELISPOT IFN-γ
As for the mucosal humoral response, several studies have documented the presence of virus-specific anti-S IgA antibodies (directed against the Spike protein) in the nasopharyngeal secretions or saliva of infected individuals. To date, there is no routinely-used test for measuring mucosal antibodies to SARS-CoV-2, notably secretory anti-S IgA, and to analyze their neutralizing activity.
Our study will thus enable us to develop and qualify methods for analyzing mucosal immunity to SARS-CoV-2. These methods will be essential for analyzing mucosal response to this virus.
Once these analytical methods have been validated, they will make it possible to study the mucosal response to infection but also the mucosal response induced by vaccination against SARS-CoV-2, particularly when using nasal vaccines.
Indeed, the vaccines currently used to combat SARS-CoV-2 induce serum neutralizing activity against protein S (Spike). Their intramuscular route of administration will induce systemic immunity, providing protection against severe forms of the infection. Nevertheless, mucosal immunity induced by current vaccines remains low. The development of a nasally-administered vaccine is an interesting avenue, as it would provide more complete protection, notably by controlling virus replication in the upper respiratory tract, thus inducing upper respiratory tract, thereby inducing herd immunity and reducing transmission of the virus.
- Being tested
- Sampling, PCR (polymerase chain reaction) SARS-CoV-2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamplingBiological
At baseline, nasal, salivary and blood sampling will be taken for the participants.
PCR (polymerase chain reaction) SARS-CoV-2Biological
At baseline, this PCR SARS-CoV-2 will be taken for the participants.
| Study group | Role | What they receive |
|---|---|---|
| COVID + | Other | participant with a positive SARS-CoV-2 PCR test Receives: Biological: Sampling; Biological: PCR (polymerase chain reaction) SARS-CoV-2 |
| COVID - | Other | participant with a negative SARS-CoV-2 PCR test Receives: Biological: Sampling; Biological: PCR (polymerase chain reaction) SARS-CoV-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the anti-Spike mucosal humoral immune response by measuring secretory IgA in nasal secretions
The level of secretory IgA (immunoglobulin A) in nasal secretions, expressed in picograms per milliliter equivalent.
Measured: Baseline - Day 0
Analysis of the neutralizing capacity of anti-Spike IgA in nasal secretions
The neutralizing capacity of secretory nasal IgA assessed in neutralization titer (PRNT 50).
Measured: Baseline - Day 0
Secondary outcomes (6)
Determination of secretory anti-Spike IgA in salivary secretions
Secretory IgA levels in saliva expressed in picograms per milliliter Eq
Measured: Baseline - Day 0
Analysis of the neutralizing capacity of anti-Spike IgA in salivary secretions
Salivary IgA neutralizing capacity assessed by neutralizing titer (PRNT 50)
Measured: Baseline - Day 0
Determination of serum anti-Spike IgG
Blood anti-S IgG (immunoglobulin G) levels expressed in Binding Antibody Units per milliliter (BAU/ml)
Measured: Baseline - Day 0
Analysis of the neutralizing capacity of serum anti-Spike IgG
Blood IgG neutralizing capacity assessed by neutralizing titer (PRNT 50)
Measured: Baseline - Day 0
Assay serum anti-N IgG
Blood anti-N IgG levels expressed as an index
Measured: Baseline - Day 0
Study the systemic cellular immune response by measuring interferon-gamma production
T-cell reactivity expressed in the number of Spot Forming Units per 106 Peripheral Blood Mononuclear Cells (SFU: Spot Forming Unit)
Measured: Baseline - Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Certain Disorders Involving the Immune MechanismStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter cross-sectional study comparing short-term mucosal response in individuals recently infected with SARS-CoV-2 versus recently non-infected individuals. The study will consist of two parts: 1. Part A, which focuses on developing the technique, involves prospective data collection and the collection of biological samples (nasal, salivary, and blood samples). 2. Part B, which aims to qualify the analysis method, also includes prospective data collection and the collection of biological samples. Once the threshold is reached in one of the two groups in Phase A, Phase B will begin concurrently.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zoha MAAKAROUN-VERMESSE, MD-PHD, Principal investigator, CHRU de TOURS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06142279
- Sponsor's protocol ID
- DR230062-MUCOVID
- Acronym
- MUCOVID
- Status last verified
- Nov 2023
- First submitted
- 14 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haute autorité de santé. Aspect immunologiques et virologiques de l'infection par le SARS-CoV-2 ; Rapport HAS 25 Novembre 2020
Alu A, Chen L, Lei H, Wei Y, Tian X, Wei X. Intranasal COVID-19 vaccines: From bench to bed. EBioMedicine. 2022 Feb;76:103841. doi: 10.1016/j.ebiom.2022.103841. Epub 2022 Jan 24.
PubMed 35085851Y. Jouan · M. Si-Tahar · A. Guillon. Immunité de la muqueuse respiratoire : physiologie et implications en réanimation. Méd. Intensive Réa 2017 ; 26 :11-20
Smith N, Goncalves P, Charbit B, Grzelak L, Beretta M, Planchais C, Bruel T, Rouilly V, Bondet V, Hadjadj J, Yatim N, Pere H, Merkling SH, Ghozlane A, Kerneis S, Rieux-Laucat F, Terrier B, Schwartz O, Mouquet H, Duffy D, Di Santo JP. Distinct systemic and mucosal immune responses during acute SARS-CoV-2 infection. Nat Immunol. 2021 Nov;22(11):1428-1439. doi: 10.1038/s41590-021-01028-7. Epub 2021 Sep 1.
PubMed 34471264Chavda VP, Vora LK, Pandya AK, Patravale VB. Intranasal vaccines for SARS-CoV-2: From challenges to potential in COVID-19 management. Drug Discov Today. 2021 Nov;26(11):2619-2636. doi: 10.1016/j.drudis.2021.07.021. Epub 2021 Jul 29.
PubMed 34332100Denis F, Alain S, Hantz S, Lagrange P. [Antiviral vaccination and respiratory mucosal immunity: still disappointing results from a seductive idea]. Presse Med. 2005 Oct 8;34(17):1245-53. doi: 10.1016/s0755-4982(05)84165-x. French.
PubMed 16230967Russell MW, Mestecky J. Mucosal immunity: The missing link in comprehending SARS-CoV-2 infection and transmission. Front Immunol. 2022 Aug 17;13:957107. doi: 10.3389/fimmu.2022.957107. eCollection 2022.
PubMed 36059541Tang J, Zeng C, Cox TM, Li C, Son YM, Cheon IS, Wu Y, Behl S, Taylor JJ, Chakaraborty R, Johnson AJ, Shiavo DN, Utz JP, Reisenauer JS, Midthun DE, Mullon JJ, Edell ES, Alameh MG, Borish L, Teague WG, Kaplan MH, Weissman D, Kern R, Hu H, Vassallo R, Liu SL, Sun J. Respiratory mucosal immunity against SARS-CoV-2 after mRNA vaccination. Sci Immunol. 2022 Oct 28;7(76):eadd4853. doi: 10.1126/sciimmunol.add4853. Epub 2022 Oct 21.
PubMed 35857583Yaugel-Novoa M, Bourlet T, Paul S. Role of the humoral immune response during COVID-19: guilty or not guilty? Mucosal Immunol. 2022 Jun;15(6):1170-1180. doi: 10.1038/s41385-022-00569-w. Epub 2022 Oct 4.
PubMed 36195658
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Qualification of Methods for Analyzing the Mucosal Immune Response to COVID-19
- ClinicalTrials.gov ID
- NCT06142279
- Acronym / sponsor ID
- MUCOVID / DR230062-MUCOVID
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 21 Nov 2023 (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 pandemic associated with the SARS-CoV-2 coronavirus has affected over 760 million individuals worldwide, resulting in more than 6.9 million deaths. France has also been heavily impacted, with over 39.8 million infections and 167,000 deaths.
SARS-CoV-2 primarily causes an upper respiratory tract infection transmitted through the air. When it reaches the lungs, it leads to a severe acute respiratory illness called COVID-19. The body's response to this viral assault primarily occurs at the level of the respiratory mucosa.
This mucosal response is complex, involving various levels of activity. Mucosal immunity is therefore essential for an adequate and long-term immune response against viral respiratory infections, including SARS-CoV-2 infection.
Infection with SARS-CoV-2 triggers a humoral immune response with the production of antibodies in the blood (serum antibodies) and antibodies in the upper respiratory tract (mucosal antibodies). It also induces a cellular immune response by activating specific blood T lymphocytes.
Tests used to measure the humoral blood response against SARS-CoV-2 and their neutralizing capacity are now well identified, as are tests for assessing the serum cellular T lymphocyte response. However, tests for measuring mucosal immune responses are not routinely used.
Our study aims to develop and qualify methods for analyzing mucosal immunity directed against SARS-CoV-2. These methods will be essential for a more precise analysis of the body's mucosal response to this virus.
Once these analytical methods are validated, they will enable the study of mucosal responses to infection, as well as mucosal responses induced by vaccination against SARS-CoV-2, particularly in the context of future nasal vaccine use.
Detailed description
SARS-CoV-2 is initially responsible for an airborne infection of the upper respiratory tract which, on reaching the lungs, causes a severe acute respiratory illness known as COVID-19.
The organism's response to this viral aggression is initially directed at the respiratory mucosa.
This mucosal response is complex, with different levels of activity interacting: mechanical activity, with the secretion of mucus that acts as a barrier to the infectious agent; physico-chemical activity, with the production of enzymes and cytokines that contribute to the degradation of viral particles; and specific humoral immune activity, with the production of secretory IgA-type immunoglobulins at the mucosal level, with neutralizing activity that blocks viral entry into the host cell.
These innate and adaptive immune mechanisms, together with their humoral and cellular components, play an essential role in mucosal barrier function. Mucosal immunity is therefore essential for an adequate, early and long-term immune response against respiratory viral infections.
SARS-CoV-2 is an enveloped virus with a helical capsid and a genome consisting of approximately 30,000 nucleotides. This genome codes for several proteins essential for virion formation, including the S protein for Spike and the N protein for nucleocapsid.
The viral S protein binds to the host cell's angiotensin-converting enzyme 2 (ACE2). ACE2 thus acts as a viral receptor mediating viral entry into the cell and the triggering an immune response in the host. This protein S is the main target of the neutralizing antibody response. Mutations in protein S have been responsible for the emergence of variants of SARS-CoV-2 with different phenotypes affecting transmission and susceptibility to antibody.
The N protein is a highly immunogenic glycoprotein also involved in viral replication and in the modulation of cellular signalling pathways. During virion assembly virion, the N protein binds to viral RNA and leads to the formation of the helical nucleocapsid. This N protein is highly conserved in all SARS-CoV-2 variants and may therefore be an interesting target in the universal defense against this virus.
In the event of a respiratory infection, stimulation of the mucosal immune system triggers on the one hand, a humoral response with the release of secretory immunoglobulins, mainly secretory IgA. The main role of IgA is to prevent the virus from spreading throughout the body.
On the other hand, respiratory infection will also trigger a mucosal cellular response primarily mediated by T lymphocytes.
Infection with SARS-CoV-2 triggers an immune response involving antibody production in the blood (serum antibodies), stimulation of blood lymphocytes and antibody production in the upper respiratory tract (mucosal antibodies). The quantitative anti-SARS-CoV-2 humoral response in the blood (serum antibodies) has been assessed by various tests. For the time being, however, it relies mainly on EIA-type tests, with blood levels of anti-S IgG (directed against the Spike protein) and anti-N IgG (directed against the nucleocapsid protein). Qualitative analysis of this response is based on the ability of these antibodies to have neutralizing activity (neutralizing antibodies).
The anti-SARS-CoV-2 T lymphocyte cellular response also appears to be important in controlling infection. The most rapid test for assessing this T lymphocyte response is the ELISPOT IFN-γ
As for the mucosal humoral response, several studies have documented the presence of virus-specific anti-S IgA antibodies (directed against the Spike protein) in the nasopharyngeal secretions or saliva of infected individuals. To date, there is no routinely-used test for measuring mucosal antibodies to SARS-CoV-2, notably secretory anti-S IgA, and to analyze their neutralizing activity.
Our study will thus enable us to develop and qualify methods for analyzing mucosal immunity to SARS-CoV-2. These methods will be essential for analyzing mucosal response to this virus.
Once these analytical methods have been validated, they will make it possible to study the mucosal response to infection but also the mucosal response induced by vaccination against SARS-CoV-2, particularly when using nasal vaccines.
Indeed, the vaccines currently used to combat SARS-CoV-2 induce serum neutralizing activity against protein S (Spike). Their intramuscular route of administration will induce systemic immunity, providing protection against severe forms of the infection. Nevertheless, mucosal immunity induced by current vaccines remains low. The development of a nasally-administered vaccine is an interesting avenue, as it would provide more complete protection, notably by controlling virus replication in the upper respiratory tract, thus inducing upper respiratory tract, thereby inducing herd immunity and reducing transmission of the virus.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter cross-sectional study comparing short-term mucosal response in individuals recently infected with SARS-CoV-2 versus recently non-infected individuals. The study will consist of two parts: 1. Part A, which focuses on developing the technique, involves prospective data collection and the collection of biological samples (nasal, salivary, and blood samples). 2. Part B, which aims to qualify the analysis method, also includes prospective data collection and the collection of biological samples. Once the threshold is reached in one of the two groups in Phase A, Phase B will begin concurrently.
| Arm | Type | Receives |
|---|---|---|
| COVID + | Other | Biological: Sampling, Biological: PCR (polymerase chain reaction) SARS-CoV-2participant with a positive SARS-CoV-2 PCR test |
| COVID - | Other | Biological: Sampling, Biological: PCR (polymerase chain reaction) SARS-CoV-2participant with a negative SARS-CoV-2 PCR test |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years old
- Participant affiliated with a social security scheme
- Participant willing to take part in the study and having provided consent
- Participant in good health or with a stable chronic condition for more than 6 months
Key exclusion criteria (5 listed)
- Contraindication for nasopharyngeal sampling
- Pregnant or breastfeeding women
- Participants benefiting from a legal protection measure as referred to in articles L1121-5 to L1121-8 of the Public Health Code (guardianship, trusteeship, etc.)
- Participant with an acute condition unrelated to SARS-CoV-2 infection
- Participant with an unstable chronic condition
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 |
|---|---|---|
| SamplingAt baseline, nasal, salivary and blood sampling will be taken for the participants. | Biological | COVID +, COVID - |
| PCR (polymerase chain reaction) SARS-CoV-2At baseline, this PCR SARS-CoV-2 will be taken for the participants. | Biological | COVID +, COVID - |
Primary outcome
To study the anti-Spike mucosal humoral immune response by measuring secretory IgA in nasal secretions
Time frame: Baseline - Day 0
The level of secretory IgA (immunoglobulin A) in nasal secretions, expressed in picograms per milliliter equivalent.
Analysis of the neutralizing capacity of anti-Spike IgA in nasal secretions
Time frame: Baseline - Day 0
The neutralizing capacity of secretory nasal IgA assessed in neutralization titer (PRNT 50).
6 secondary outcomes
Determination of secretory anti-Spike IgA in salivary secretions
Time frame: Baseline - Day 0
Analysis of the neutralizing capacity of anti-Spike IgA in salivary secretions
Time frame: Baseline - Day 0
Determination of serum anti-Spike IgG
Time frame: Baseline - Day 0
Analysis of the neutralizing capacity of serum anti-Spike IgG
Time frame: Baseline - Day 0
Assay serum anti-N IgG
Time frame: Baseline - Day 0
Study the systemic cellular immune response by measuring interferon-gamma production
Time frame: Baseline - Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- BackgroundHaute autorité de santé. Aspect immunologiques et virologiques de l'infection par le SARS-CoV-2 ; Rapport HAS 25 Novembre 2020
- Background: PubMed 35085851Alu A, Chen L, Lei H, Wei Y, Tian X, Wei X. Intranasal COVID-19 vaccines: From bench to bed. EBioMedicine. 2022 Feb;76:103841. doi: 10.1016/j.ebiom.2022.103841. Epub 2022 Jan 24.
- BackgroundY. Jouan · M. Si-Tahar · A. Guillon. Immunité de la muqueuse respiratoire : physiologie et implications en réanimation. Méd. Intensive Réa 2017 ; 26 :11-20
- Background: PubMed 34471264Smith N, Goncalves P, Charbit B, Grzelak L, Beretta M, Planchais C, Bruel T, Rouilly V, Bondet V, Hadjadj J, Yatim N, Pere H, Merkling SH, Ghozlane A, Kerneis S, Rieux-Laucat F, Terrier B, Schwartz O, Mouquet H, Duffy D, Di Santo JP. Distinct systemic and mucosal immune responses during acute SARS-CoV-2 infection. Nat Immunol. 2021 Nov;22(11):1428-1439. doi: 10.1038/s41590-021-01028-7. Epub 2021 Sep 1.
- Background: PubMed 34332100Chavda VP, Vora LK, Pandya AK, Patravale VB. Intranasal vaccines for SARS-CoV-2: From challenges to potential in COVID-19 management. Drug Discov Today. 2021 Nov;26(11):2619-2636. doi: 10.1016/j.drudis.2021.07.021. Epub 2021 Jul 29.
- Background: PubMed 16230967Denis F, Alain S, Hantz S, Lagrange P. [Antiviral vaccination and respiratory mucosal immunity: still disappointing results from a seductive idea]. Presse Med. 2005 Oct 8;34(17):1245-53. doi: 10.1016/s0755-4982(05)84165-x. French.
- Background: PubMed 36059541Russell MW, Mestecky J. Mucosal immunity: The missing link in comprehending SARS-CoV-2 infection and transmission. Front Immunol. 2022 Aug 17;13:957107. doi: 10.3389/fimmu.2022.957107. eCollection 2022.
- Background: PubMed 35857583Tang J, Zeng C, Cox TM, Li C, Son YM, Cheon IS, Wu Y, Behl S, Taylor JJ, Chakaraborty R, Johnson AJ, Shiavo DN, Utz JP, Reisenauer JS, Midthun DE, Mullon JJ, Edell ES, Alameh MG, Borish L, Teague WG, Kaplan MH, Weissman D, Kern R, Hu H, Vassallo R, Liu SL, Sun J. Respiratory mucosal immunity against SARS-CoV-2 after mRNA vaccination. Sci Immunol. 2022 Oct 28;7(76):eadd4853. doi: 10.1126/sciimmunol.add4853. Epub 2022 Oct 21.
- Background: PubMed 36195658Yaugel-Novoa M, Bourlet T, Paul S. Role of the humoral immune response during COVID-19: guilty or not guilty? Mucosal Immunol. 2022 Jun;15(6):1170-1180. doi: 10.1038/s41385-022-00569-w. Epub 2022 Oct 4.
- Individual participant dataSharing planned: No
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.
Zoha MAAKAROUN-VERMESSE, MD-PHD principal investigator
CHRU de TOURS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sampling and PCR (polymerase chain reaction) SARS-CoV-2 in people with Certain Disorders Involving the Immune Mechanism, run by University Hospital, Tours 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zoha MAAKAROUN-VERMESSE, MD-PHD (0247476972, z.maakaroun-vermesse@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the anti-Spike mucosal humoral immune response by measuring secretory IgA in nasal secretions (time frame: Baseline - Day 0). The study lists 2 primary outcomes in all. 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 NCT06142279, which also lists 9 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 21 Nov 2023.