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

NCT05043259 | Completed Phase 1 DMC

• 1 other identifier: JSVCT127
• Study Type: interventional
• Target: 423
• Locations: 1 country
• Sites: 1

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

Keywords

SARS-CoV-2; Aerosolised COVID-19 vaccine; Recombinant Ad5 Vector; Inactivated Vaccine; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse reactions within 14 days after the booster dose.

  Incidence of adverse reactions within 14 days after vaccination.

  Within 14 days the booster dose

• GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster dose.

  GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the vaccination.

  On day 14 after the booster dose

Secondary Outcomes (8)

• Incidence of adverse events within 0-28 days after the booster dose.

  within 28 days after the booster dose.

• Incidence of serious adverse events (SAE) till the 12 months after the booster dose.

  within 12 months after the booster dose.

• GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 7 and 28 after the booster dose.

  on day 7 and 28 after the boost vaccination.

• Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14 after the booster vaccination.

  on day 14 after the last dose of 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.

  at month 3, 6, and 12 after the boost vaccination.

Study Arms (3)

Inactivated vaccine group

ACTIVE COMPARATOR

Subjects who have been vaccinated with two doses of inactivated SARS-CoV-2 vaccine will receive one dose of inactivated SARS-CoV-2 vaccine

Biological: inactive SARS-CoV-2 vaccine (Vero cell)

Low dose aerosolized Ad5-nCoV group

EXPERIMENTAL

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.

Biological: Low dose aerosolized Ad5-nCoV

High dose aerosolized Ad5-nCoV group

EXPERIMENTAL

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.

Biological: High dose aerosolized Ad5-nCoV

Interventions

inactive SARS-CoV-2 vaccine (Vero cell) BIOLOGICAL

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

Inactivated vaccine group

Low dose aerosolized Ad5-nCoV 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.

Low dose aerosolized Ad5-nCoV group

High dose aerosolized Ad5-nCoV 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.

High dose aerosolized Ad5-nCoV group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Donghai County Center for Diseases Control and Prevention

Lianyungang, Jiangsu, China

Location

Related Publications (2)

• 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.

  PMID: 36503413 DERIVED

• 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.

  PMID: 35605625 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jing-Xin Li, PhD

  Jiangsu Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 14, 2021
• Study Start: August 14, 2021
• Primary Completion: November 1, 2021
• Study Completion: October 31, 2022
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

CN (1)