Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-31 @ 1:33 PM
Study NCT ID:
NCT05009134
Status:
UNKNOWN
Last Update Posted:
2022-03-17
First Post:
2021-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influences of Allergic Rhinitis and Allergen Immunotherapy on SARS-CoV-2 Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood samples will be collected at baseline (prior to vaccinate), 7 and 30 after first vaccine, and, 7 and 30 after second vaccine.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-16', 'studyFirstSubmitDate': '2021-08-10', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay', 'timeFrame': 'Jun 2021-Aug 2021', 'description': 'Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay'}, {'measure': 'Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood', 'timeFrame': 'Jun 2021-Aug 2021', 'description': 'Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood'}, {'measure': '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', 'timeFrame': 'Jun 2021-Aug 2021', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis', 'Allergen Immunotherapy', 'SARS-CoV-2']}, 'referencesModule': {'references': [{'pmid': '36655976', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '35649178', 'type': 'DERIVED', 'citation': 'Yao 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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nObjectives: To investigate if AR and AIT will influence the humoral response to SARS-CoV-2 vaccination in adults.\n\nDesign 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.\n\nIntervention 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year', 'eligibilityCriteria': 'Inclusion Criteria:\n\n18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year\n\nExclusion Criteria:\n\n1. who infected with COVID-19 previously\n2. Cannot finish the follow up\n3. Previous allergic to other vaccines\n4. who have had severe immunologic, cardiac, liver or metabolic disease, tumors, allergic diseases, or chronic infection,\n5. pregnancy or breastfeeding\n6. Suffered from airway infection or severe infectious diseases in the past 3 months, prior to this study.'}, 'identificationModule': {'nctId': 'NCT05009134', 'briefTitle': 'Influences of Allergic Rhinitis and Allergen Immunotherapy on SARS-CoV-2 Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Huazhong University of Science and Technology'}, 'officialTitle': 'Influences of Allergic Rhinitis and Allergen Immunotherapy on Human Antibody Responses to SARS-CoV-2 Vaccination', 'orgStudyIdInfo': {'id': 'ENT-ALLERGY-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': '18-55 years, healthy', 'interventionNames': ['Biological: There is no intervention in this study.']}, {'label': 'Allergic rhinitis', 'description': 'patients with AR without AIT', 'interventionNames': ['Biological: There is no intervention in this study.']}, {'label': 'Allergen immunotherapy', 'description': 'patients with AR with AIT for more than 1 year', 'interventionNames': ['Biological: There is no intervention in this study.']}], 'interventions': [{'name': 'There is no intervention in this study.', 'type': 'BIOLOGICAL', 'description': 'There is no intervention in this study.', 'armGroupLabels': ['Allergen immunotherapy', 'Allergic rhinitis', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zheng Liu, Doctor', 'role': 'CONTACT', 'email': 'zhengliuent@hotmail.com', 'phone': '86 027 83663807'}, {'name': 'Rong-Fei Zhu, Doctor', 'role': 'CONTACT', 'email': 'zrf13092@163.com', 'phone': '86 027 83663809'}, {'name': 'Zheng Liu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rong-Fei Zhu, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Zheng Liu, Doctor', 'role': 'CONTACT', 'email': 'zhengliuent@hotmail.com', 'phone': '86 027 83663807'}, {'name': 'Rong-Fei Zhu, Doctor', 'role': 'CONTACT', 'email': 'zrf13092@163.com'}], 'overallOfficials': [{'name': 'Zheng Liu, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Otolaryngology-Head & Neck Surgery, Deputy Dean of Tongji Hospital, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'investigatorFullName': 'Zheng Liu', 'investigatorAffiliation': 'Huazhong University of Science and Technology'}}}}