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COVID-19Phase 4NCT05313646

Clinical Evaluation for Batch Consistency of Ad5-nCoV in Chinese Healthy Adults

A Phase 4 study testing batch 1 of Ad5-nCoV, batch 2 of Ad5-nCoV and batch 3 of 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, double-blind, parallel-controlled, equivalence trial, for evaluation of safety and immunogenicity, and batch-to-batch consistency of a recombinant adenovirus type-5-vectored Covid-19 vaccine Convidecia in one shot schedule in Chinese healthy adults aged 18 years and 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?
batch 1 of Ad5-nCoV, batch 2 of Ad5-nCoV and batch 3 of Ad5-nCoV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,050 participants
Where
1 siteChina
Study dates
8 Mar 2021to 8 Sep 2021
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

  • healthy participants aged 18 years and above who have not received COVID-19 vaccine.
  • The subjects can provide with informed consent and sign informed consent form (ICF).
  • 4. The subjects are able to and willing to comply with the requirements of the clinical trial program and could complete the follow-up of the study.
  • 5. Axillary temperature ≤ 37.0℃. 6. negative IgM and IgG against SARS-CoV-2 7. with BMI between18.5 to 30.0 8. No history of epidemiological contact with COVID-2019 9. have not been to medium or high risk areas in the past 21 days and have no history of departure.
  • 10. be determined to be healthy by medical history, physical examination and clinical examination and meet the requirements for immunization of this product.

Who cannot join

  • Medical history or family history of convulsion, epilepsy, encephalopathy and psychosis.
  • Allergic to any component of the research vaccines, or a history of hypersensitivity or serious reactions to vaccination.
  • Women with positive urine pregnancy test, pregnant or breast-feeding, or have a pregnancy plan in this study.
  • Suffering from acute febrile disease, infectious disease, or SARS infection history
  • Serious cardiovascular disease, such as arrhythmia, conduction block, myocardial infarction, severe hypertension, which cannot be controlled by medication (systolic blood pressure ≥180mmHg, diastolic blood pressure ≥110mmHg)
  • Have severe chronic diseases or unstable condition ( Grade 3 or higher as defined in the guidelines for the classification of adverse events in clinical trials for prophylactic vaccines), Such as diabetes, thyroid disease and so on.
Show all 19Show fewer
  • Congenital or acquired angioedema / neuroedema.
  • had urticaria one year before this vaccination.
  • Asplenia or functional asplenia.
  • Thrombocytopenia or other clotting disorder (this may contraindicate intramuscular injection).
  • Faintng during acupuncture treatment
  • Received immunosuppressant therapy, antiallergic therapy, cytotoxic therapy, high dose inhaled corticosteroid over the past 6 months (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid for acute non-complicated dermatitis, and corticosteroid with dose less than 20mg/ day)
  • Received blood products within 4 months before vaccination.
  • Received other investigational drugs within 1 month prior to receiving the investigational vaccines.
  • Received other live attenuated vaccines within 1 month prior to receiving the investigational vaccines.
  • Received subunit or inactivated vaccine within 14 days prior to receiving investigational vaccine.
  • Be receiving anti-tuberculosis treatment
  • Have the history of SARS-CoV-2 infection or COVID-19
  • Any medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the study protocol or affect the subjects' informed consent

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guanyun Center for Disease Control and Prevention

    Lianyungang, Jiangsu, 222000

Other trials in China

About this study

Official title: Safety, Immunogenicity, and Batch Consistency of a Single Dose of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Chinese Healthy Adults Aged 18 Years and Above: a Randomized, Double-blind, Parallel-controlled Clinical Trial

This is a randomized, double-blind, parallel-controlled, equivalence trial, for evaluation of safety and immunogenicity, and batch-to-batch consistency of a recombinant adenovirus type-5-vectored Covid-19 vaccine Convidecia in one shot schedule in Chinese healthy adults aged 18 years and above. In total 1050 healthy adults will be recruited in this study. Subjects in both cohort will be randomized stratified into two cohort by age(18~59 years and≥60 years) in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia. The primary objective is to test the equivalence of the immune responses to three consecutive manufacturing lots of Convidecia in healthy adults. The secondary objectives were to evaluate the immunogenicity and safety of Convidecia for each lot and the pooled data of three lots)

Conditions
COVID-19
Being tested
batch 1 of Ad5-nCoV, batch 2 of Ad5-nCoV, batch 3 of Ad5-nCoV
Keywords
SARS-CoV-2 Vaccine, Batches consistency, Adenovirus type-5-vectored, 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.

  • batch 1 of Ad5-nCoVBiological

    Also called Convidecia

    The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101001. It contains 5×10^10 viral particles per 0.5 mL in a vial.

  • batch 2 of Ad5-nCoVBiological

    Also called Convidecia

    The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202101002. It contains 5×10^10 viral particles per 0.5 mL in a vial.

  • batch 3 of Ad5-nCoVBiological

    Also called Convidecia

    The vaccine is a replication defective Ad5 vectored vaccine expressing the full-length spike glycoprotein of SARS-CoV-2 produced by CanSino, lot NCOV202102003. It contains 5×10^10 viral particles per 0.5 mL in a vial.

Study groups in NCT05313646
Study groupRoleWhat they receive
batch 1 of Ad5-nCoVExperimentalEligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101001.
Receives: Biological: batch 1 of Ad5-nCoV
batch 2 of Ad5-nCoVExperimentalEligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202101002.
Receives: Biological: batch 2 of Ad5-nCoV
batch 3 of Ad5-nCoVExperimentalEligible subjects in both cohort were vaccinated with one injection of Ad5-nCoV, lot NCOV202102003.
Receives: Biological: batch 3 of Ad5-nCoV

What is being measured

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

  1. GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

    GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

    Measured: On day 28 after vaccination

Secondary outcomes (7)

  1. GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

    GMFIs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination.

    Measured: On day 28 after vaccination

  2. Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination.

    Propotion of participants with at least four-fold increase of post-vaccination antibody level against SARS-CoV-2 RBD-specific binding IgG compared to that at baseline on day 28 after vaccination.

    Measured: On day 28 after vaccination

  3. GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody levels against Ad5 at baseline.

    GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination stratified by neutralizing antibody

    Measured: On day 28 after vaccination

  4. Incidence of solicited adverse events within 7 days after vaccination.

    Incidence of solicited adverse events within 7 days after vaccination.

    Measured: Within 7 days after vaccination

  5. Incidence of adverse reactions within 28 days after vaccination.

    Incidence of adverse reactions within 28 days after vaccination.

    Measured: Within 28 days after vaccination

  6. Incidence of unsolicited adverse events within 28 days after vaccination.

    Incidence of unsolicited adverse events within 28 days after vaccination.

    Measured: Within 28 days after vaccination

  7. Incidence of serious adverse events (SAE) within the 6 months after vaccination.

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

    Measured: Within the 6 months after vaccination

Timeline

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

  1. First posted6 Apr 2022
  2. Study start8 Mar 2021
  3. Primary completion8 Apr 2021
  4. Study completion8 Sep 2021

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
Model description
Subjects in adults cohort and elderly cohort will be randomized in a 1:1:1 ratio to receive one of three consecutive batches of Convidecia, respectively.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,050 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05313646
Sponsor's protocol ID
JSVCT111
Status last verified
Dec 2021
First submitted
28 Mar 2022
Last updated
6 Apr 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li ZP, Shi YF, Hou LH, Jin PF, Ma SH, Pan HX, Zhang JL, Shan YM, Huang HT, Wu SP, Du P, Wang X, Wang LL, Wang RJ, Wang Y, Wang XW, Zhu FC, Li JX. Batch-to-batch consistency trial of an adenovirus type-5 vector-based COVID-19 vaccine in adults aged 18 years and above. Expert Rev Vaccines. 2022 Dec;21(12):1843-1849. doi: 10.1080/14760584.2022.2119133. Epub 2022 Sep 1.

    PubMed 36048417

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing batch 1 of Ad5-nCoV, batch 2 of Ad5-nCoV and batch 3 of 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 5 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 6 Apr 2022. 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?

GMTs of SARS-CoV-2 RBD-specific binding IgG on day 28 after vaccination. (time frame: On day 28 after vaccination). 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 NCT05313646, 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 6 Apr 2022.

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