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Heterologous Boost Immunization With an Aerosolised Ad5-nCoV After Two-dose 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: NCT05204589
Recruitment Status : Active, not recruiting
First Posted : January 24, 2022
Last Update Posted : May 17, 2022
Sponsor:
Collaborators:
Anhui Provincial Center for Disease Control and Prevention
Shandong Province Centers for Disease Control and Prevention
Hunan Provincial Center for Disease Control and Prevention
Yunnan Center for Disease Control and Prevention
Chongqing Center for Disease Control and Prevention
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is a multicenter, open-label, partially radomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolised adenovirus type-5 vector-based COVID-19 vaccine (Ad5-nCoV-IH) after two-dose priming with an inactivated SARS-CoV-2 vaccine (ICV) in adults aged 18 years and above. 10420 healthy subjects aged over or equal to 18 years whom have received two doses of ICV before 6 months or more, will be recruited from six provinces in China in this study.Of them, 10000 eligible participants in an open cohort will receive a booster dose of Ad5-nCoV-IH to evaluate the safety profile. Another 420 participants were involved in immunogenicity cohort and randomized in a ratio of 1:1 to receive a boost of Ad5-nCoV-IH or ICV. The ICV homologous to the priming series will be supplied as the booster. The occurrence of adverse reactions within 28 days and serious adverse events within 6 months after vaccination will be observed in all participants. In addition, blood and saliva samples will be collected from all participants in immunogenicity cohort on the day 0 before and 14, 28 and month 3 and 6 after the booster vaccination. Each subject will remain in this study for approximately 6 months.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Aerosolized Ad5-nCoV Biological: Inactivated SARS-CoV-2 vaccine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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 Aged 18 Years and Above: a Multicenter, Open-label, Partially Parallel-controlled Clinical Trial
Actual Study Start Date : January 22, 2022
Actual Primary Completion Date : April 1, 2022
Estimated Study Completion Date : September 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Subjects in safety cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV
 Biological: Aerosolized Ad5-nCoV
Aerosolized Ad5-nCoV 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: Group B
Subjects in immunogenicity cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV
 Biological: Aerosolized Ad5-nCoV
Aerosolized Ad5-nCoV 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: Group C
Subjects in immunogenicity cohort will receive one homologous booster dose of ICV.
 Biological: Inactivated SARS-CoV-2 vaccine
Inactivated SARS-CoV-2 vaccine is homologous to the priming series which have been administered to the subjects, produced by SinoVac Biotech Co,. Ltd, Beijing Institute of Biological Products Co,. Ltd, Wuhan Institute of Biological Products Co,. Ltd, or Biokangtai.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of adverse reactions within 28 days after the booster dose. [ Time Frame: Within 28 days the booster dose ]
    Incidence of adverse reactions within 28 days after the booster dose.

  2. GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort. [ Time Frame: On day 28 after the booster dose ]
    GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.


Secondary Outcome Measures :
  1. Incidence of adverse reactions within 30 minutes after the booster dose. [ Time Frame: Within 30 minutes after the booster dose ]
    Incidence of adverse reactions within 30 minutes after the booster dose.

  2. Incidence of adverse reactions within 14 days after the booster dose. [ Time Frame: Within 14 days after the booster dose ]
    Incidence of adverse reactions within 14 days after the booster dose.

  3. Incidence of adverse events within 28 days after the booster dose. [ Time Frame: Within 28 days after the booster dose ]
    Incidence of adverse events within 28 days after the booster dose.

  4. Incidence of serious adverse events (SAE) till the 6 months after the booster dose. [ Time Frame: Within 6 months after the booster dose ]
    Incidence of serious adverse events (SAE) till the 6 months after booster vaccination.

  5. Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose. [ Time Frame: On day 28 after the boost vaccination ]
    Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.

  6. GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose. [ Time Frame: On day 14, month 3 and 6 after the booster dose ]
    GMT, Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus as compared to baseline on day 14, month 3 and 6 after the booster dose.

  7. 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.

  8. Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose. [ Time Frame: On day 14, day 28 and month 3 and 6 after the booster dose ]
    Geometric mean concentration (GMC), fold increase and seroconversion of binding IgG against S protein of SARS-CoV-2 on day 14, day 28 and month 3 and 6 after the booster dose.

  9. GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline. [ Time Frame: On day 28 after the booster dose ]
    GMT of neutralizing antibodies against live SARS-CoV-2 virus in participants with pre-existing anti-Ad5 antibody titers>1:200 or ≤1:200 at baseline.

  10. GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose. [ Time Frame: On day 28 after the booster dose ]
    GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus on day 28 after the booster dose.

  11. The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination. [ Time Frame: On day 14 after the booster vaccination ]
    The levels of IFN-γ、TNF-α、IL-2、IL-4、IL-5、IL-13 secreted by specific T cells on day 14 after the booster vaccination.


Eligibility Criteria
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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.


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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.
  • Have received two-dose inactivated SARS-CoV-2 vaccine before 6 months or more.
  • 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 6-month follow-up of the study.

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.
  • Women with positive urine pregnancy test.
  • Have acute febrile diseases and infectious diseases.
  • Axillary temperature>37.0℃.
  • Have serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured in the field).
  • 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.
  • Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities.
  • Have history of SARS-CoV-2 infection or COVID-19.
  • Have symptoms of upper respiratory tract infection.
  • Have traveled to medium or high risk areas or traveled abroad in the past 21 days, and epidemiologically contacted with SARS-CoV-2.
  • Any medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's informed consent.
Contacts and Locations
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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): NCT05204589


Locations
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China, Jiangsu
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, Jiangsu, China, 210009
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Anhui Provincial Center for Disease Control and Prevention
Shandong Province Centers for Disease Control and Prevention
Hunan Provincial Center for Disease Control and Prevention
Yunnan Center for Disease Control and Prevention
Chongqing Center for Disease Control and Prevention
Investigators
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Principal Investigator: Fengcai Zhu, Prof Jiangsu Provincial Center for Diseases Control and Prevention
More Information
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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT05204589    
Other Study ID Numbers: JSVCT137
First Posted: January 24, 2022    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: March 2022

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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:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases