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.
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.
Biological: There is no intervention in this study.
There is no intervention in this study.
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.
Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Investigator: Zheng Liu, Doctor
Contact: 86 027 83663807
zhengliuent@hotmail.com
Zheng Liu, Doctor
86 027 83663807
zhengliuent@hotmail.com
Rong-Fei Zhu, Doctor
zrf13092@163.com
Zheng Liu, Doctor, Study Chair
Tongji Hospital