Status:
COMPLETED
Heterologous Boost Immunization with an Aerosolised Ad5-nCoV After Two-dose Priming with an Inactivated SARS-CoV-2 Vaccine
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Collaborating Sponsors:
Anhui Provincial Center for Disease Control and Prevention
Shandong Province Centers for Disease Control and Prevention
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a multicenter, open-label, partially radomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolised adenov...
Eligibility Criteria
Inclusion
- Health subjects aged ≥18 years.
- Have received two-dose inactivated SARS-CoV-2 vaccine before 6 months or more.
- The subject can provide with informed consent and sign informed consent form (ICF).
- The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the 6-month follow-up of the study.
Exclusion
- Have the medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
- Be allergic to any component of the research vaccines, or used to have a history of hypersensitivity or serious reactions to vaccination.
- Women with positive urine pregnancy test.
- Have acute febrile diseases and infectious diseases.
- Axillary temperature\>37.0℃.
- Have serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured in the field).
- Have severe chronic diseases or condition in progress cannot be smoothly controlled, such as asthma, diabetes, thyroid disease.
- Congenital or acquired angioedema / neuroedema.
- Have the history of urticaria 1 year before receiving the investigational vaccine.
- Have asplenia or functional asplenia.
- Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities.
- Have history of SARS-CoV-2 infection or COVID-19.
- Have symptoms of upper respiratory tract infection.
- Have traveled to medium or high risk areas or traveled abroad in the past 21 days, and epidemiologically contacted with SARS-CoV-2.
- Any medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's informed consent.
Key Trial Info
Start Date :
January 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
10285 Patients enrolled
Trial Details
Trial ID
NCT05204589
Start Date
January 22 2022
End Date
October 27 2022
Last Update
February 21 2025
Active Locations (1)
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1
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009