We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05043259
Recruitment Status : Active, not recruiting
First Posted : September 14, 2021
Last Update Posted : August 16, 2022
Sponsor:
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
 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.
 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.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
China, Jiangsu
Donghai County Center for Diseases Control and Prevention
Lianyungang, Jiangsu, China
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Investigators
Layout table for investigator information
Principal Investigator: Jing-Xin Li, PhD Jiangsu Provincial Center for Diseases Control and Prevention
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
SARS-CoV-2
Aerosolised COVID-19 vaccine
Recombinant Ad5 Vector
 Inactivated Vaccine
Safety
Immunogenicity
Additional relevant MeSH terms:
Layout table for MeSH terms
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