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COVID-19Phase 1/2NCT05043259

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

A Phase 1/2 study testing inactive SARS-CoV-2 vaccine (Vero cell), Low dose aerosolized Ad5-nCoV and High dose aerosolized Ad5-nCoV 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 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. 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?
inactive SARS-CoV-2 vaccine (Vero cell), Low dose aerosolized Ad5-nCoV and High dose aerosolized Ad5-nCoV
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
423 participants
Where
1 siteChina
Study dates
14 Aug 2021to 31 Oct 2022
Phase
Phase 1/2
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, 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

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.
  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Donghai County Center for Diseases Control and Prevention

    Lianyungang, Jiangsu

Other trials in China

About this study

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

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
Being tested
inactive SARS-CoV-2 vaccine (Vero cell), Low dose aerosolized Ad5-nCoV, High dose aerosolized Ad5-nCoV
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.

  • 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.

  • Low dose aerosolized Ad5-nCoVBiological

    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.

  • High dose aerosolized Ad5-nCoVBiological

    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.

Study groups in NCT05043259
Study groupRoleWhat they receive
Inactivated vaccine groupActive comparatorSubjects who have been vaccinated with two doses of inactivated SARS-CoV-2 vaccine will receive one dose of inactivated SARS-CoV-2 vaccine
Receives: Biological: inactive SARS-CoV-2 vaccine (Vero cell)
Low dose aerosolized Ad5-nCoV groupExperimentalSubjects 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.
Receives: Biological: Low dose aerosolized Ad5-nCoV
High dose aerosolized Ad5-nCoV groupExperimentalSubjects 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.
Receives: Biological: High dose aerosolized Ad5-nCoV

What is being measured

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

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

    Incidence of adverse reactions within 14 days after vaccination.

    Measured: Within 14 days the booster dose

  2. 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.

    Measured: On day 14 after the booster dose

Secondary outcomes (8)

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

    Incidence of adverse events (AE) within 0-28 days after the booster vaccination.

    Measured: within 28 days after the booster dose.

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

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

    Measured: within 12 months after the booster dose.

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

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

    Measured: on day 7 and 28 after the boost vaccination.

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

    Measured: on day 14 after the last dose of 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.

    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.

  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.

    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.

    Measured: 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.

    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.

    Measured: 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.

    The levels of IFN- γ、IL-2 and IL-13 secreted by specific T cells on day 7 and 14 after the booster vaccination.

    Measured: on day 7 and 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 posted14 Sep 2021
  2. Study start14 Aug 2021
  3. Primary completion1 Nov 2021
  4. Study completion31 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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
423 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05043259
Sponsor's protocol ID
JSVCT127
Status last verified
Feb 2025
First submitted
13 Sep 2021
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36503413

  • 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.

    PubMed 35605625

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing inactive SARS-CoV-2 vaccine (Vero cell), Low dose aerosolized Ad5-nCoV and High dose aerosolized Ad5-nCoV 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 6 inclusion and 19 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 days after the booster dose. (time frame: Within 14 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 NCT05043259, which also lists 2 linked publications.

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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