Clinical trial NCT05009134: Influences of Allergic Rhinitis and Allergen Immunotherapy on SARS-CoV-2 Vaccination
Official title: Influences of Allergic Rhinitis and Allergen Immunotherapy on Human Antibody Responses to SARS-CoV-2 Vaccination
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allergic Rhinitis
Allergen Immunotherapy
SARS-CoV-2
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2021-08-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT for more than 1 year

Exclusion Criteria:

1. who infected with COVID-19 previously
2. Cannot finish the follow up
3. Previous allergic to other vaccines
4. who have had severe immunologic, cardiac, liver or metabolic disease, tumors, allergic diseases, or chronic infection,
5. pregnancy or breastfeeding
6. Suffered from airway infection or severe infectious diseases in the past 3 months, prior to this study.

Primary outcomes:
measure: Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay
timeFrame: Jun 2021-Aug 2021
measure: Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood
timeFrame: Jun 2021-Aug 2021
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
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Zheng Liu, Doctor
role: STUDY_CHAIR
References:
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.