Status:
COMPLETED
Heterologous Boost Immunization with Ad5-nCoV After Three-dose Priming with an Inactivated SARS-CoV-2 Vaccine
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is an open-label, randomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolized (Ad5-nCoV-IH) or intramuscu...
Eligibility Criteria
Inclusion
- Health subjects aged ≥18 years
- 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.
- Participants who have received three-dose of inactivated SARS-CoV-2 vaccine more than 6 months ago.
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.
- Vaccine-related SAE occurred after previous vaccination with COVID-19 vaccine.
- Women with positive urine pregnancy test or in lactation.
- Have acute febrile diseases or infectious diseases or have a history of SARS.
- Axillary temperature\>37.0℃
- Have serious cardiovascular diseases, 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 is not stable, such as asthma, diabetes, thyroid disease
- Congenital or acquired angioedema / neuroedema.
- Have the history of urticaria 1 year before.
- 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 :
April 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT05303584
Start Date
April 23 2022
End Date
May 31 2023
Last Update
February 21 2025
Active Locations (1)
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1
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China