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COVID-19Phase 4NCT05303584

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

A Phase 4 study testing Ad5-nCoV-IH, Ad5-nCoV-IM and CoronaVac 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 an open-label, randomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolized (Ad5-nCoV-IH) or intramuscular (Ad5-nCoV-IM) Ad5-nCoV after three-dose priming with an inactivated COVID-19 vaccine (CoronaVac) in adults aged 18… 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?
Ad5-nCoV-IH, Ad5-nCoV-IM and CoronaVac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
362 participants
Where
1 siteChina
Study dates
23 Apr 2022to 31 May 2023
Phase
Phase 4
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
  • 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.
  • Participants who have received three-dose of inactivated SARS-CoV-2 vaccine more than 6 months ago.

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.
  • Vaccine-related SAE occurred after previous vaccination with COVID-19 vaccine.
  • Women with positive urine pregnancy test or in lactation.
  • Have acute febrile diseases or infectious diseases or have a history of SARS.
  • Axillary temperature>37.0℃
Show all 16Show fewer
  • Have serious cardiovascular diseases, 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 is not stable, such as asthma, diabetes, thyroid disease
  • Congenital or acquired angioedema / neuroedema.
  • Have the history of urticaria 1 year before.
  • 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

Other trials in China

About this study

Official title: Immunogenicity and Safety of the Heterologous Prime-boost Immunization with an Adenovirus Type-5 Vector-based COVID-19 Vaccine (Ad5-nCoV) After Three-dose Priming with an Inactivated COVID-19 Vaccine in Adults Aged 18 Years and Above: a Randomized, Open-label, Parallel-controlled Clinical Trial

This is an open-label, randomized, parallel-controlled clinical trial to evaluate the safety and immunogenicity of heterologous prime-boost immunization with an aerosolized (Ad5-nCoV-IH) or intramuscular (Ad5-nCoV-IM) Ad5-nCoV after three-dose priming with an inactivated COVID-19 vaccine (CoronaVac) in adults aged 18 years and above. A total of 360 subjects will be included. Approximately 210 subjects who have completed three doses of CoronaVac more than 6 months ago in the prior clinical trial and other 150 eligible subjects will be recruited and randomized respectively in a ratio of 1:1:1 to receive a booster dose of Ad5-nCoV-IH or Ad5-nCoV-IM or ICV. 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 on the day 0 before and 14, 28 days and 3, 6 months after the booster vaccination. Each subject will remain in this study for approximately 6 months.

Conditions
COVID-19
Being tested
Ad5-nCoV-IH, Ad5-nCoV-IM, CoronaVac
Keywords
SARS-CoV-2, Ad5-nCoV, 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.

  • Ad5-nCoV-IHBiological

    Also called aerosolized Ad5-nCoV, Convidecia

    The orally aerosolized Ad5-nCoV is a replication defective Ad5 vectored COVID-19 vaccine expressing the full-length spike gene of wide-type SARS-CoV-2, Wuhan-Hu-1. The Ad5-nCoV vaccine was supplied in 1.5mL/vial, at a concentration of 1.0 × 1011 viral particles per mL as a liquid formulation. 0.1 ml of Ad5-nCoV vaccine will be aerosolized by using Continuous Vapouring System. Then, the aerosolized droplets will be poured into a disposable suction cup and be inhaled by participants through mouth.

  • Ad5-nCoV-IMBiological

    Also called intramuscular Ad5-nCoV

    The Ad5-nCoV is a replication defective Ad5 vectored COVID-19 vaccine expressing the full-length spike gene of wide-type SARS-CoV-2, Wuhan-Hu-1. It was supplied in 1·5mL/vial, at a concentration of 1.0 × 1011 viral particles per mL as a liquid formulation. Participants will be administrated 0.5ml（5×1010VP）of Ad5-nCoV vaccine intramuscularly.

  • CoronaVacBiological

    CoronaVac is an inactivated whole-virion vaccine with aluminium hydroxide as the adjuvant, prepared with a novel coronavirus (CZ02 strain) inoculated in African green monkey kidney cells (Vero cells). One dose of CoronaVac contains 3 μg of SARS-CoV-2 virion in a 0.5 mL aqueous suspension for injection with 0.45 mg/mL of aluminium.

Study groups in NCT05303584
Study groupRoleWhat they receive
Group AExperimentalApproximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive a booster dose of aerosolized Ad5-nCoV after three-dose priming with ICV
Receives: Biological: Ad5-nCoV-IH
Group BExperimentalApproximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive a booster dose of intramuscular Ad5-nCoV after three-dose priming with CoronaVac
Receives: Biological: Ad5-nCoV-IM
Group CExperimentalApproximately 70 subjects recruited from the prior clinical trial and newly enrolled 50 subjects will receive homologous fourth dose of CoronaVac.
Receives: Biological: CoronaVac

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.

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

    Measured: On day 28 after the booster dose

Secondary outcomes (7)

  1. Geometric Mean Fold Increase (GMI) and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 28 after the booster dose.

    GMI 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

  2. GMT, GMI and seroconversion of neutralizing antibodies against live SARS-CoV-2 virus on day 14, month 3 and 6 after the booster dose.

    GMT, GMI 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

  3. Geometric mean concentration (GMC), GMI and seroconversion of anti-SARS-CoV-2 NP-specific, RBD-specific and NTD-specific IgG measured by ELISA on day 14, day 28 and month 3 and 6 after the booster dose.

    Geometric mean concentration (GMC), GMI and seroconversion of anti-SARS-CoV-2 NP-specific, RBD-specific and NTD-specific IgG measured by ELISA 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

  4. 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

  5. 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

  6. 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

  7. Incidence of serious adverse events (SAE) until 6 months after the booster dose.

    Incidence of SAE until 6 months after booster vaccination.

    Measured: Within 6 months after the booster dose

Timeline

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

  1. First posted31 Mar 2022
  2. Study start23 Apr 2022
  3. Primary completion20 Jun 2022
  4. Study completion31 May 2023

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
362 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05303584
Sponsor's protocol ID
JSVCT153
Status last verified
Feb 2025
First submitted
22 Mar 2022
Last updated
21 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Xia X, Tan ZM, Wan P, Zheng H, Tang R, Chen XQ, Guo XL, Zhu T, Feng JL, Zhong J, Li XL, Zhang ZY, Zhu FC, Li JX. Environmental Impact Assessment for the Use of an Orally Aerosolized Adenovirus Type-5 Vector-Based COVID-19 Vaccine in Randomized Clinical Trials. J Infect Dis. 2023 Sep 15;228(6):715-722. doi: 10.1093/infdis/jiad134.

    PubMed 37202147

  • Tang R, Zheng H, Wang BS, Gou JB, Guo XL, Chen XQ, Chen Y, Wu SP, Zhong J, Pan HX, Zhu JH, Xu XY, Shi FJ, Li ZP, Liu JX, Zhang XY, Cui LB, Song ZZ, Hou LH, Zhu FC, Li JX; CanSino COVID-19 Study Group. Safety and immunogenicity of aerosolised Ad5-nCoV, intramuscular Ad5-nCoV, or inactivated COVID-19 vaccine CoronaVac given as the second booster following three doses of CoronaVac: a multicentre, open-label, phase 4, randomised trial. Lancet Respir Med. 2023 Jul;11(7):613-623. doi: 10.1016/S2213-2600(23)00049-8. Epub 2023 Mar 7.

    PubMed 36898400

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ad5-nCoV-IH, Ad5-nCoV-IM and CoronaVac 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 16 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 NCT05303584, 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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