Heterologous Boost Immunization with an Aerosolised Ad5-nCoV After Two-dose Priming with an Inactivated SARS-CoV-2 Vaccine

February 19, 2025 updated by: Jiangsu Province Centers for Disease Control and Prevention

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10285

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Jiangsu Provincial Center for Diseases Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Within 28 days the booster dose
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.
On day 28 after the booster dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Within 30 minutes after the booster dose
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.
Within 14 days after the booster dose
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.
Within 28 days after the booster dose
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.
Within 6 months after the booster dose
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.
On day 28 after the boost vaccination
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.
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 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.
At month 3, 6, and 12 after the boost vaccination.
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.
On day 14, day 28 and month 3 and 6 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.
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.
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.
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.
On day 28 after the booster dose
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.
On day 14 after the booster vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiangsu Province Centers for Disease Control and Prevention

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hunan Provincial Center for Disease Control and Prevention
Yunnan Center for Disease Control and Prevention
Shandong Province Centers for Disease Control and Prevention
Anhui Provincial Center for Disease Control and Prevention
Chongqing Center for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fengcai Zhu, Prof, Jiangsu Provincial Center for Diseases Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JSVCT137

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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