- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05043259
Heterologous Prime-boost Immunization With an Aerosolised Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Priming With an Inactivated SARS-CoV-2 Vaccine
August 12, 2022 updated by: Jiangsu Province Centers for Disease Control and Prevention
Immunogenicity and Safety of the Heterologous Prime-boost Immunization With an Aerosolised Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Two-dose Priming With an Inactivated SARS-CoV-2 Vaccine in Adults at 18 Years of Age or Above: a Randomised, Open-label, Parallel-controlled Clinical Trial
This is a randomized, open-label, parallel-controlled study to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV) after priming with an inactivated SARS-CoV-2 vaccine in adults at 18 years of age or above.
420 healthy subjects aged over or equal to 18 years whom have received two doses of inactivated SARS-CoV-2 vaccines within the last 3~9 months, will be recruited in this study.
Eligible participants will be randomized at a 1:1:1 ratio to receive a booster dose of inactive SARS-CoV-2 vaccine or a low dose of aerosolized Ad5-nCoV or a high dose of aerosolized Ad5-nCoV.
The occurrence of adverse events within 28 days and serious adverse events within 6 months after vaccination will be observed.
In addition, blood samples will be collected on the day 0 before and day 7, 14, 28 and month 3, 6, and 12 after the booster vaccination.
Each subject will remain in this study for approximately 13 months.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
420
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Lianyungang, Jiangsu, China
- Donghai County Center for Diseases Control and Prevention
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Health subjects aged ≥18 years, completed two dose of inactive SARS-CoV-2 vaccine in the past 3-9 months.
- 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 12-month follow-up of the study.
- No nasal or oral diseases, such as acute rhinitis (sinusitis), allergic rhinitis, oral ulcer, sore throat, etc.
- Axillary temperature ≤ 37.0℃
- Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination and clinical judgment of the investigator and meet the requirements of immunization
Exclusion Criteria:
- 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.
- suffering from abnormal pulmonary function such as asthma, chronic obstructive pulmonary disease and pulmonary fibrosis.
- suffering from more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medication.
- have symptoms of upper respiratory tract infection.
- women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan within six months.
- have acute febrile diseases and infectious diseases.
- 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.
- have thrombocytopenia or other coagulation disorders (which may cause contraindications for intramuscular injection).
- have needle sickness.
- have the history of immunosuppressive therapy, anti-allergy therapy, cytotoxic therapy or inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and acute corticosteroid therapy without dermatitis) over the past 6 months.
- have received blood products within 4 months before injection of investigational vaccines.
- have received another investigational product within one month before injection of investigational vaccine.
- have received attenuated vaccine within 1 month before injection of investigational vaccine.
- under anti-tuberculosis treatment.
- not be able to follow the protocol, or not be able to understand the informed consent according to the researcher's judgment, due to various medical, psychological, social or other conditions.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Inactivated vaccine group
Subjects who have been vaccinated with two doses of inactivated SARS-CoV-2 vaccine will receive one dose of inactivated SARS-CoV-2 vaccine
|
This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd.
0.5 ml / bottle.
|
EXPERIMENTAL: Low dose aerosolized Ad5-nCoV group
Subjects who have been vaccinated with two doses of inactivated SARS-CoV-2 vaccine will receive one dose of the low dose of aerosolized Ad5-nCoV.
|
This vaccine is produced by CanSino Biologics Inc.
It is a liquid dosage form, 0.1 ml / dose, contains 1×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, aerosol inhalation.
|
EXPERIMENTAL: High dose aerosolized Ad5-nCoV group
Subjects who have been vaccinated with two doses of inactivated SARS-CoV-2 vaccine will receive one dose of the high dose of aerosolized Ad5-nCoV.
|
This vaccine is produced by CanSino Biologics Inc.
It is a liquid dosage form, 0.2 ml / dose, contains 2×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, aerosol inhalation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.
Time Frame: On day 14 after the booster dose
|
GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the vaccination.
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On day 14 after the booster dose
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Incidence of adverse reactions within 14 days after the booster dose.
Time Frame: Within 14 days the booster dose
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Incidence of adverse reactions within 14 days after vaccination.
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Within 14 days the booster dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events within 0-28 days after the booster dose.
Time Frame: within 28 days after the booster dose.
|
Incidence of adverse events (AE) within 0-28 days after the booster vaccination.
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within 28 days after the booster dose.
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Incidence of serious adverse events (SAE) till the 12 months after the booster dose.
Time Frame: within 12 months after the booster dose.
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Incidence of serious adverse events (SAE) till the 12 months after booster vaccination.
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within 12 months after the booster dose.
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GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose.
Time Frame: on day 7 and 28 after the boost vaccination.
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GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose.
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on day 7 and 28 after the boost vaccination.
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Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster vaccination.
Time Frame: on day 14 after the last dose of vaccination.
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Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, on day 14 after the booster vaccination.
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on day 14 after the last dose of vaccination.
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GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.
Time Frame: at month 3, 6, and 12 after the boost vaccination.
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GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.
|
at month 3, 6, and 12 after the boost vaccination.
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GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 RBD on day 7, day 14, day 28 after the booster dose.
Time Frame: on day 7, day 14, day 28 after the booster vaccination.
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GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA on day 7, day 14, day 28 after the booster vaccination.
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on day 7, day 14, day 28 after the booster vaccination.
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GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 RBD at month 3, 6, and 12 after the booster dose.
Time Frame: at month 3, 6, and 12 after the booster vaccination.
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GMT, fold increase and seroconversion of binding antibodies against SARS-CoV-2 S and N protein measured by ELISA at month 3, 6, and 12 after the booster vaccination.
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at month 3, 6, and 12 after the booster vaccination.
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The levels of IFN- γ、IL-2 and IL-13 secreted by specific T cells on day 7 and 14 after the booster vaccination.
Time Frame: on day 7 and 14 after the booster vaccination.
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The levels of IFN- γ、IL-2 and IL-13 secreted by specific T cells on day 7 and 14 after the booster vaccination.
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on day 7 and 14 after the booster vaccination.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 13, 2021
Primary Completion (ANTICIPATED)
August 13, 2022
Study Completion (ANTICIPATED)
December 30, 2022
Study Registration Dates
First Submitted
September 13, 2021
First Submitted That Met QC Criteria
September 13, 2021
First Posted (ACTUAL)
September 14, 2021
Study Record Updates
Last Update Posted (ACTUAL)
August 16, 2022
Last Update Submitted That Met QC Criteria
August 12, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JSVCT127
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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