The study is designed to assess whether allergic rhinitis and allergen immunotherapyaffect the humoral response to SARS-CoV-2 Vaccination in adults. This is a prospectivestudy 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