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

NCT ID: NCT05043259

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 423 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-14
• Study Completion Date: 2022-10-31

Brief Summary

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

inactive SARS-CoV-2 vaccine (Vero cell)

Intervention Type: BIOLOGICAL

This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research \& Development Co., Ltd. 0.5 ml / bottle.

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.

Group Type: EXPERIMENTAL

Low dose aerosolized Ad5-nCoV

Intervention Type: BIOLOGICAL

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.

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.

Group Type: EXPERIMENTAL

High dose aerosolized Ad5-nCoV

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing-Xin Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Diseases Control and Prevention

Locations

Donghai County Center for Diseases Control and Prevention

Lianyungang, Jiangsu, China

Countries

China

References

Jin L, Tang R, Wu S, Guo X, Huang H, Hou L, Chen X, Zhu T, Gou J, Zhong J, Pan H, Cui L, Chen Y, Xia X, Feng J, Wang X, Zhao Q, Xu X, Li Z, Zhang X, Chen W, Li J, Zhu F. Antibody persistence and safety after heterologous boosting with orally aerosolised Ad5-nCoV in individuals primed with two-dose CoronaVac previously: 12-month analyses of a randomized controlled trial. Emerg Microbes Infect. 2023 Dec;12(1):2155251. doi: 10.1080/22221751.2022.2155251.

Reference Type: DERIVED

PMID: 36503413 (View on PubMed)

Li JX, Wu SP, Guo XL, Tang R, Huang BY, Chen XQ, Chen Y, Hou LH, Liu JX, Zhong J, Pan HX, Shi FJ, Xu XY, Li ZP, Zhang XY, Cui LB, Tan WJ, Chen W, Zhu FC; CanSino COVID-19 Study Group. Safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised Ad5-nCoV after two-dose priming with an inactivated SARS-CoV-2 vaccine in Chinese adults: a randomised, open-label, single-centre trial. Lancet Respir Med. 2022 Aug;10(8):739-748. doi: 10.1016/S2213-2600(22)00087-X. Epub 2022 May 20.

Reference Type: DERIVED

PMID: 35605625 (View on PubMed)

Other Identifiers

JSVCT127

Identifier Type: -

Identifier Source: org_study_id