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COVID-19Phase 3NCT05204589

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

A Phase 3 study testing Aerosolized Ad5-nCoV and Inactivated SARS-CoV-2 vaccine in people with COVID-19, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
Aerosolized Ad5-nCoV and Inactivated SARS-CoV-2 vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,285 participants
Where
1 siteChina
Study dates
22 Jan 2022to 27 Oct 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Provincial Center for Diseases Control and Prevention

    Nanjing, Jiangsu, 210009

Other trials in China

About this study

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

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.

Conditions
COVID-19
Being tested
Aerosolized Ad5-nCoV, Inactivated SARS-CoV-2 vaccine
Keywords
SARS-CoV-2, Aerosolised COVID-19 vaccine, Recombinant Ad5 Vector, Inactivated Vaccine, Safety, Immunogenicity
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerosolized Ad5-nCoVBiological

    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.

  • Inactivated SARS-CoV-2 vaccineBiological

    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.

Study groups in NCT05204589
Study groupRoleWhat they receive
Group AExperimentalSubjects in safety cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV
Receives: Biological: Aerosolized Ad5-nCoV
Group BExperimentalSubjects in immunogenicity cohort will receive one heterologous booster dose of aerosolized Ad5-nCoV
Receives: Biological: Aerosolized Ad5-nCoV
Group CExperimentalSubjects in immunogenicity cohort will receive one homologous booster dose of ICV.
Receives: Biological: Inactivated SARS-CoV-2 vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse reactions within 28 days after the booster dose.

    Incidence of adverse reactions within 28 days after the booster dose.

    Measured: Within 28 days the booster dose

  2. GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.

    GMT of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.

    Measured: On day 28 after the booster dose

Secondary outcomes (11)

  1. Incidence of adverse reactions within 30 minutes after the booster dose.

    Incidence of adverse reactions within 30 minutes after the booster dose.

    Measured: Within 30 minutes after the booster dose

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

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

    Measured: Within 14 days after the booster dose

  3. Incidence of adverse events within 28 days after the booster dose.

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

    Measured: Within 28 days after the booster dose

  4. Incidence of serious adverse events (SAE) till the 6 months after the booster dose.

    Incidence of serious adverse events (SAE) till the 6 months after booster vaccination.

    Measured: Within 6 months after the booster dose

  5. Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.

    Fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose in immunogenicity cohort.

    Measured: On day 28 after the boost vaccination

  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.

    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.

    Measured: 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.

    GMT, fold increase and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus at month 3, 6, and 12 after the booster dose.

    Measured: At month 3, 6, and 12 after the boost vaccination.

  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.

    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.

    Measured: 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.

    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.

    Measured: On day 28 after the booster dose

  10. GMT, fold increase and seroconversion of neutralizing antibodies against VOC/VOI of SARS-CoV-2 virus 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.

    Measured: 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.

    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.

    Measured: On day 14 after the booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start22 Jan 2022
  3. Primary completion1 Apr 2022
  4. Study completion27 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10,285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05204589
Sponsor's protocol ID
JSVCT137
Status last verified
Feb 2025
First submitted
21 Jan 2022
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li JX, Hou LH, Gou JB, Yin ZD, Wu SP, Wang FZ, Zhang Z, Peng ZH, Zhu T, Shen HB, Chen W, Zhu FC; Six-Province COVID-19 Vaccine Study Group. Safety, immunogenicity and protection of heterologous boost with an aerosolised Ad5-nCoV after two-dose inactivated COVID-19 vaccines in adults: a multicentre, open-label phase 3 trial. Lancet Infect Dis. 2023 Oct;23(10):1143-1152. doi: 10.1016/S1473-3099(23)00350-X. Epub 2023 Jun 20.

    PubMed 37352880

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aerosolized Ad5-nCoV and Inactivated SARS-CoV-2 vaccine in people with COVID-19, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse reactions within 28 days after the booster dose. (time frame: Within 28 days the booster dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05204589, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.

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