Allergic RhinitisNCT05009134
Influences of Allergic Rhinitis and Allergen Immunotherapy on SARS-CoV-2 Vaccination
An observational study of Allergic Rhinitis and Allergen Immunotherapy, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
The study is designed to assess whether allergic rhinitis and allergen immunotherapy affect the humoral response to SARS-CoV-2 Vaccination in adults. This is a prospective study enrolling a total of approximately 120 subjects, 18-55 years old. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Allergic Rhinitis, Allergen Immunotherapy, SARS-CoV-2
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2021to 30 Apr 2022
- Phase
- Observational
- 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 55 years
- All sexes
- Adult
Study population: 18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year
Who may be able to join
- 18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year
Who cannot join
- who infected with COVID-19 previously
- Cannot finish the follow up
- Previous allergic to other vaccines
- who have had severe immunologic, cardiac, liver or metabolic disease, tumors, allergic diseases, or chronic infection,
- pregnancy or breastfeeding
- Suffered from airway infection or severe infectious diseases in the past 3 months, prior to this study.
Trial locations and contacts
1 site in 1 country.
Rong-Fei Zhu, Doctor contact
China1 site, 1 recruiting
- Recruiting
Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Zheng Liu, Doctor, 86 027 83663807, zhengliuent@hotmail.com
Rong-Fei Zhu, Doctor, 86 027 83663809, zrf13092@163.com
About this study
Official title: Influences of Allergic Rhinitis and Allergen Immunotherapy on Human Antibody Responses to SARS-CoV-2 Vaccination
The study is designed to assess whether allergic rhinitis and allergen immunotherapy affect the humoral response to SARS-CoV-2 Vaccination in adults. This is a prospective study enrolling a total of approximately 120 subjects, 18-55 years old.
Read the detailed description
Background: Allergic rhinitis (AR) is a disorder caused by hypersensitivity of the immune system to harmless allergens in the environment, which represents a global public health problem affecting up to 20-50% of the population. Allergen immunotherapy (AIT) is the only effective treatment that not only has disease-modifying property but also confers long-term clinical benefit after cessation of treatment for AR patients. Vaccination is one of the most powerful interventions for reducing disability and death caused by infectious disease. Immunization with the inactivated SARS-CoV-2 Vaccine remains the most effective strategy to combat COVID-19 infections. Nevertheless, the influences of allergic rhinitis and allergen immunotherapy on SARS-CoV-2 vaccination are still unknown.
Objectives: To investigate if AR and AIT will influence the humoral response to SARS-CoV-2 vaccination in adults.
Design and trial size: This is a prospective study. A total of approximately 120 subjects, 18-55 years old, including 40 healthy subjects, 40 patients with AR without AIT, and 40 patients with AR with AIT for more than 1 year, will be enrolled in this study.
Intervention and duration: All of the study participants will be vaccinated with an 2 doses inactivated vaccine against SARS-CoV-2 (COVILO). Peripheral blood samples will be collected at baseline (prior to vaccinate), 7 and 30 after first vaccine, and, 7 and 30 after second vaccine. One-month additional data analysis leads to the trial duration of 3 months.
- Conditions
- Allergic Rhinitis, Allergen Immunotherapy, SARS-CoV-2
- Being tested
- There is no intervention in this study.
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no intervention in this study.Biological
There is no intervention in this study.
| Study group | Role | What they receive |
|---|---|---|
| Control | 18-55 years, healthy Receives: Biological: There is no intervention in this study. | |
| Allergic rhinitis | patients with AR without AIT Receives: Biological: There is no intervention in this study. | |
| Allergen immunotherapy | patients with AR with AIT for more than 1 year Receives: Biological: There is no intervention in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay
Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay
Measured: Jun 2021-Aug 2021
Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood
Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood
Measured: Jun 2021-Aug 2021
Levels of antigen-specific IgE and IgG4, IFN-γ, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA
Levels of antigen-specific IgE and IgG4, IFN-γ, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA
Measured: Jun 2021-Aug 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start4 Jun 2021
- Primary completion20 Mar 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
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 Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Zheng Liu, Huazhong University of Science and Technology
- Investigators
- Zheng Liu, Doctor, Study chair, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009134
- Sponsor's protocol ID
- ENT-ALLERGY-01
- Status last verified
- Mar 2022
- First submitted
- 10 Aug 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao X, Luo K, Wang D, Wei Y, Yao Y, Deng J, Yang Y, Zeng Q, Dong X, Xiong L, Gong D, Lin L, Pohl K, Liu S, Liu Y, Liu L, Nguyen THO, Allen LF, Kedzierska K, Jin Y, Du MR, Chen W, Lu L, Shen N, Liu Z, Cockburn IA, Luo W, Yu D. T follicular helper 17 (Tfh17) cells are superior for immunological memory maintenance. Elife. 2023 Jan 19;12:e82217. doi: 10.7554/eLife.82217.
PubMed 36655976Yao Y, Huang A, Deng YK, Liu Y, Zhu HY, Wang N, Wang ZZ, Zhu RF, Yu D, Liu Z. Allergen Immunotherapy Reverses Immune Response to SARS-CoV-2 Vaccine in Patients with Allergic Rhinitis: A Prospective Observational Trial. Am J Respir Crit Care Med. 2022 Sep 15;206(6):780-783. doi: 10.1164/rccm.202203-0608LE. No abstract available.
PubMed 35649178
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influences of Allergic Rhinitis and Allergen Immunotherapy on Human Antibody Responses to SARS-CoV-2 Vaccination
- ClinicalTrials.gov ID
- NCT05009134
- Acronym / sponsor ID
- ENT-ALLERGY-01
- Conditions
- Allergic Rhinitis, Allergen Immunotherapy, SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- 20 Mar 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 17 Aug 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 study is designed to assess whether allergic rhinitis and allergen immunotherapy affect the humoral response to SARS-CoV-2 Vaccination in adults. This is a prospective study enrolling a total of approximately 120 subjects, 18-55 years old.
Detailed description
Background: Allergic rhinitis (AR) is a disorder caused by hypersensitivity of the immune system to harmless allergens in the environment, which represents a global public health problem affecting up to 20-50% of the population. Allergen immunotherapy (AIT) is the only effective treatment that not only has disease-modifying property but also confers long-term clinical benefit after cessation of treatment for AR patients. Vaccination is one of the most powerful interventions for reducing disability and death caused by infectious disease. Immunization with the inactivated SARS-CoV-2 Vaccine remains the most effective strategy to combat COVID-19 infections. Nevertheless, the influences of allergic rhinitis and allergen immunotherapy on SARS-CoV-2 vaccination are still unknown.
Objectives: To investigate if AR and AIT will influence the humoral response to SARS-CoV-2 vaccination in adults.
Design and trial size: This is a prospective study. A total of approximately 120 subjects, 18-55 years old, including 40 healthy subjects, 40 patients with AR without AIT, and 40 patients with AR with AIT for more than 1 year, will be enrolled in this study.
Intervention and duration: All of the study participants will be vaccinated with an 2 doses inactivated vaccine against SARS-CoV-2 (COVILO). Peripheral blood samples will be collected at baseline (prior to vaccinate), 7 and 30 after first vaccine, and, 7 and 30 after second vaccine. One-month additional data analysis leads to the trial duration of 3 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Biological: There is no intervention in this study.18-55 years, healthy |
| Allergic rhinitis | – | Biological: There is no intervention in this study.patients with AR without AIT |
| Allergen immunotherapy | – | Biological: There is no intervention in this study.patients with AR with AIT for more than 1 year |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- 18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year
Key inclusion criteria (1 listed)
- 18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year
Key exclusion criteria (6 listed)
- who infected with COVID-19 previously
- Cannot finish the follow up
- Previous allergic to other vaccines
- who have had severe immunologic, cardiac, liver or metabolic disease, tumors, allergic diseases, or chronic infection,
- pregnancy or breastfeeding
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 |
|---|---|---|
| There is no intervention in this study.There is no intervention in this study. | Biological | Allergen immunotherapy, Allergic rhinitis, Control |
Primary outcome
Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay
Time frame: Jun 2021-Aug 2021
Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay
Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood
Time frame: Jun 2021-Aug 2021
Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood
Levels of antigen-specific IgE and IgG4, IFN-γ, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA
Time frame: Jun 2021-Aug 2021
Levels of antigen-specific IgE and IgG4, IFN-γ, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Derived from this study: PubMed 36655976Gao X, Luo K, Wang D, Wei Y, Yao Y, Deng J, Yang Y, Zeng Q, Dong X, Xiong L, Gong D, Lin L, Pohl K, Liu S, Liu Y, Liu L, Nguyen THO, Allen LF, Kedzierska K, Jin Y, Du MR, Chen W, Lu L, Shen N, Liu Z, Cockburn IA, Luo W, Yu D. T follicular helper 17 (Tfh17) cells are superior for immunological memory maintenance. Elife. 2023 Jan 19;12:e82217. doi: 10.7554/eLife.82217.
- Derived from this study: PubMed 35649178Yao Y, Huang A, Deng YK, Liu Y, Zhu HY, Wang N, Wang ZZ, Zhu RF, Yu D, Liu Z. Allergen Immunotherapy Reverses Immune Response to SARS-CoV-2 Vaccine in Patients with Allergic Rhinitis: A Prospective Observational Trial. Am J Respir Crit Care Med. 2022 Sep 15;206(6):780-783. doi: 10.1164/rccm.202203-0608LE. No abstract available.
- 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.
Rong-Fei Zhu, Doctor contact
Zheng Liu, Doctor study chair
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis and Allergen Immunotherapy, run by Huazhong University of Science and Technology at 1 site in China.
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 1 inclusion and 6 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 17 Mar 2022. 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 China. 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 Zheng Liu, Doctor (86 027 83663807, zhengliuent@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay (time frame: Jun 2021-Aug 2021). The study lists 3 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 NCT05009134, 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 17 Mar 2022.