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
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ClinicalTrials.gov Identifier: NCT05043259 |
Recruitment Status :
Active, not recruiting
First Posted : September 14, 2021
Last Update Posted : August 16, 2022
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 | Biological: inactive SARS-CoV-2 vaccine (Vero cell) Biological: Low dose aerosolized Ad5-nCoV Biological: High dose aerosolized Ad5-nCoV | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 420 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Actual Study Start Date : | September 13, 2021 |
Estimated Primary Completion Date : | August 13, 2022 |
Estimated Study Completion Date : | December 30, 2022 |

Arm | Intervention/treatment |
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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
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Biological: inactive SARS-CoV-2 vaccine (Vero cell)
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.
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Biological: Low dose 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.
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Biological: High dose 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. |
- Incidence of adverse reactions within 14 days after the booster dose. [ Time Frame: Within 14 days the booster dose ]Incidence of adverse reactions within 14 days after vaccination.
- 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.
- 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.
- Incidence of serious adverse events (SAE) till the 12 months after the booster dose. [ Time Frame: within 12 months after the booster dose. ]Incidence of serious adverse events (SAE) till the 12 months after booster vaccination.
- 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. ]GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose.
- 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. ]Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus, as compared to baseline, on day 14 after the booster vaccination.
- 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. ]GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.
- 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. ]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.
- 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. ]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.
- 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. ]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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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05043259
China, Jiangsu | |
Donghai County Center for Diseases Control and Prevention | |
Lianyungang, Jiangsu, China |
Principal Investigator: | Jing-Xin Li, PhD | Jiangsu Provincial Center for Diseases Control and Prevention |
Responsible Party: | Jiangsu Province Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT05043259 |
Other Study ID Numbers: |
JSVCT127 |
First Posted: | September 14, 2021 Key Record Dates |
Last Update Posted: | August 16, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SARS-CoV-2 Aerosolised COVID-19 vaccine Recombinant Ad5 Vector |
Inactivated Vaccine Safety Immunogenicity |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |