NCT05009134

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 4, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

August 10, 2021

Last Update Submit

March 16, 2022

Conditions

Allergic RhinitisAllergen ImmunotherapySARS-CoV-2

Outcome Measures

Primary Outcomes (3)

  • 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

    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

    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

    Jun 2021-Aug 2021

Study Arms (3)

Control

18-55 years, healthy

Biological: There is no intervention in this study.

Allergic rhinitis

patients with AR without AIT

Biological: There is no intervention in this study.

Allergen immunotherapy

patients with AR with AIT for more than 1 year

Biological: There is no intervention in this study.

Interventions

There is no intervention in this study.BIOLOGICAL

There is no intervention in this study.

Allergen immunotherapyAllergic rhinitisControl

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of ENT, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (2)

  • 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: 36655976DERIVED

  • 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.

    PMID: 35649178DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples will be collected at baseline (prior to vaccinate), 7 and 30 after first vaccine, and, 7 and 30 after second vaccine.

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Zheng Liu, Doctor

    Tongji Hospital

    STUDY CHAIR

Central Study Contacts

Zheng Liu, Doctor

CONTACT

86 027 83663807zhengliuent@hotmail.com

Rong-Fei Zhu, Doctor

CONTACT

zrf13092@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Otolaryngology-Head & Neck Surgery, Deputy Dean of Tongji Hospital, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Record Dates

First Submitted

August 10, 2021

First Posted

August 17, 2021

Study Start

June 4, 2021

Primary Completion

March 20, 2022

Study Completion

April 30, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)