COVID-19NCT04916886
A Clinical Trial of Immunobridging and Lot-to-lot Consistency of COVID-19 Vaccine (Ad5-nCoV) in Different Age Groups.
A study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml and Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml in people with COVID-19, run by CanSino Biologics Inc. at 1 site in China.
Trial summary
The study is a single-center, randomized and double-blinded trial to evaluate the immunobridging between different manufacture scales, lot-to-lot consistency of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)(Ad5-nCOV) in population 6-59 years of age. Read more about this study
- Who is it for?
- Ages 6 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml and Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,021 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 2021to 31 Jul 2022
- Phase
- Interventional
- 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 6 to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 6-59 years of age at the time of enrollment;
- Able to provide consent or obtain consent from guardian to participate in the trial and sign an Informed Consent Form (ICF);
- Able and willing to complete all the scheduled study procedures during the whole study follow-up period;
- Axillary temperature ≤37.0℃;
- IgG ang IgM negative for Covid-19;
- Have not received any type of Covid-19 vaccines;
- No contact history of Covid-19; no travel history to medium and high risk regions and abroad in the past 21 days;
- Participants who are clinically determined to be healthy after checking medical history and physical examination are eligible to receive the product.
Who cannot join
- Medical or family history of convulsions, epilepsy, encephalopathy, and psychosis disorders;
- History of allergies to any ingredient of Ad5-nCoV, history of serious allergic reactions to any vaccine, history of allergies and immune diseases;
- Women who are pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the 12 months study period;
- Acute febrile diseases and infectious diseases, medical history of SARS (SARS-CoV-1);
- Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medications (on-site measurement for 18-59 years of age: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), etc;
- Severe chronic diseases or with advanced stage conditions which cannot be controlled smoothly, such as diabetes, thyroid disease, etc;
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- Congenital or acquired angioedema/neurological edema;
- Urticaria history within 1 year before receiving the study vaccine;
- Asplenia or functional aspleenia;
- Thrombocytopenia or other coagulation disorders (may cause contraindications for intramuscular injection);
- Trypanophobia；
- History of receiving immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, nebulized corticosteroid therapy in the past 6 months (not including corticosteroid spray treatment for allergic rhinitis, and surface corticosteroid treatment for acute non-complicated dermatitis);
- Prior administration of blood products in last 4 months;
- Received other investigational drugs within 1 month before the study;
- Prior administration of live attenuated vaccines within 1 month before the study;
- Prior administration of subunit or inactivated vaccines within 14 days before the study;
- Current anti-tuberculosis therapy;
- Medical history of Covid-19 disease/infection;
- Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives or informed consent (i.e. medical, psychological, social or other conditions, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Immunogenicity Bridging Between Different Manufacture Scales and Between Different Lots of Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) in Population 6-59 Years of Age.
The study is a single-center, randomized and double-blinded trial to evaluate the immunobridging between different manufacture scales, lot-to-lot consistency of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)(Ad5-nCOV) in population 6-59 years of age. The immunobridging between different manufacture scales will be evaluated first, the immunobridging between different age groups will be evaluated second, the lot-to-lot consistency will be evaluated at last.
- Conditions
- COVID-19
- Being tested
- Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml, Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml
- Keywords
- COVID-19, Vaccine, Ad5, Immunobridging, Lot-to-lot consistency
- Medical subject headings
- COVID-19, Alzheimer Disease 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5mlBiological
Containing 0.5E10vp
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3mlBiological
Containing 0.3E10vp
| Study group | Role | What they receive |
|---|---|---|
| 50L Scale (Age 18-59) | Experimental | Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml |
| 500L Scale (Age 18-59) | Experimental | Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml |
| 800L Scale (Age 18-59) | Experimental | Single dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml |
| 800L Scale Lot 1 (Age 13-17) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml |
| 800L Scale Lot 2 (Age 13-17) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml |
| 800L Scale Lot 3 (Age 13-17) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml |
| 800L Scale Lot 1 (Age 6-12) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml |
| 800L Scale Lot 2 (Age 6-12) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml |
| 800L Scale Lot 3 (Age 6-12) | Experimental | Single dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT of anti SARS-CoV-2 specific neutralizing antibody
GMT of anti SARS-CoV-2 specific neutralizing antibody in all groups (wild type variants test).
Measured: 28 days after vaccination
Secondary outcomes (13)
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Seroconversion rate of anti SARS-CoV-2 specific neutralizing antibody (wild type variants test).
Measured: 28 days after vaccination
GMI of SARS-CoV-2 neutralizing antibody
GMI of anti SARS-CoV-2 specific neutralizing antibody (wild type variants test).
Measured: 28 days after vaccination
GMT of SARS-CoV-2 S protein RBD antibody
GMT of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups
Measured: 28 days after vaccination
Seroconversion rate of SARS-CoV-2 S protein RBD antibody
Seroconversion rate of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups.
Measured: 28 days after vaccination
GMI of SARS-CoV-2 S protein RBD antibody
GMI of SARS-CoV-2 S protein RBD antibody measured by ELISA in all groups.
Measured: 28 days after vaccination
GMT of Ad5 vector neutralizing antibody
GMT of anti Ad5 vector neutralizing antibody responses post vaccination in all groups
Measured: 28 days after vaccination
GMI of Ad5 vector neutralizing antibody
GMI of Ad5 vector neutralizing antibody responses post vaccination in all groups
Measured: 28 days after vaccination
Stratified analysis on Ad5 vector neutralizing antibody
Stratified analysis based on the GMT of Ad5 vector neutralizing antibody responses post vaccination.
Measured: 28 days after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
The occurance of Adverse Reactions/Events within 30 minutes post vaccination
Measured: Within 30 minutes after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
The occurance of Adverse Reactions/Events (AE/AR) within 7 days post vaccination.
Measured: Within 0-7 days after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
The occurance of Adverse Reactions/Events (AE/AR) within 28 days post vaccination.
Measured: Within 0-28 days after vaccination
Incidence of Serious Adverse Events (SAE)
Occurance of Serious Adverse Events (SAE) post vaccination.
Measured: Within 12 months after vaccination
Incidence of Adverse Events of Special Interest (AESI)
Occurance of Adverse Events of Special Interest (AESI) post vaccination.
Measured: Within 12 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start3 Jun 2021
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Fengcai Zhu, MSD, Principal investigator, Jiangsu Provincal Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916886
- Sponsor's protocol ID
- JSVCT118
- Status last verified
- Oct 2022
- First submitted
- 30 May 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu YF, Wei MW, Wang RJ, Guo XL, Pan HX, Gao YC, Li XL, Wang X, Ma XM, Wan P, Zhou L, Zhu YW, Li JX, Zhu FC. Immunogenicity consistency and safety with different production scales of recombinant adenovirus type-5 vectored COVID-19 vaccine in healthy adults: a randomized, double-blinded, immunobridging trial. Expert Rev Vaccines. 2023 Jan-Dec;22(1):662-670. doi: 10.1080/14760584.2023.2234997.
PubMed 37432025
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Immunogenicity Bridging Between Different Manufacture Scales and Between Different Lots of Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV) in Population 6-59 Years of Age.
- ClinicalTrials.gov ID
- NCT04916886
- Acronym / sponsor ID
- JSVCT118
- Conditions
- COVID-19
- Keywords
- COVID-19, Vaccine, Ad5, Immunobridging, Lot-to-lot consistency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,021 participants (actual)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Centers for Disease Control and Prevention
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a single-center, randomized and double-blinded trial to evaluate the immunobridging between different manufacture scales, lot-to-lot consistency of the Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)(Ad5-nCOV) in population 6-59 years of age. The immunobridging between different manufacture scales will be evaluated first, the immunobridging between different age groups will be evaluated second, the lot-to-lot consistency will be evaluated at last.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 50L Scale (Age 18-59) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5mlSingle dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. |
| 500L Scale (Age 18-59) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5mlSingle dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. |
| 800L Scale (Age 18-59) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5mlSingle dose of 0.5ml Ad5-nCoV containing 0.5E10 vp. |
| 800L Scale Lot 1 (Age 13-17) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3mlSingle dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
| 800L Scale Lot 2 (Age 13-17) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3mlSingle dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
| 800L Scale Lot 3 (Age 13-17) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3mlSingle dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
| 800L Scale Lot 1 (Age 6-12) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3mlSingle dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
| 800L Scale Lot 2 (Age 6-12) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3mlSingle dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
| 800L Scale Lot 3 (Age 6-12) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3mlSingle dose of 0.3ml Ad5-nCoV containing 0.3E10 vp. |
Who may qualify
- Ages
- 6 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 6-59 years of age at the time of enrollment;
- Able to provide consent or obtain consent from guardian to participate in the trial and sign an Informed Consent Form (ICF);
- Able and willing to complete all the scheduled study procedures during the whole study follow-up period;
- Axillary temperature ≤37.0℃;
- IgG ang IgM negative for Covid-19;
Key exclusion criteria (19 listed)
- Medical or family history of convulsions, epilepsy, encephalopathy, and psychosis disorders;
- History of allergies to any ingredient of Ad5-nCoV, history of serious allergic reactions to any vaccine, history of allergies and immune diseases;
- Women who are pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the 12 months study period;
- Acute febrile diseases and infectious diseases, medical history of SARS (SARS-CoV-1);
- Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medications (on-site measurement for 18-59 years of age: systolic blood pressure ≥160mmHg, diastolic blood pressure ≥100mmHg), etc;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5mlContaining 0.5E10vp | Biological | 500L Scale (Age 18-59), 50L Scale (Age 18-59), 800L Scale (Age 18-59) |
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3mlContaining 0.3E10vp | Biological | 800L Scale Lot 1 (Age 13-17), 800L Scale Lot 1 (Age 6-12), 800L Scale Lot 2 (Age 13-17), 800L Scale Lot 2 (Age 6-12), 800L Scale Lot 3 (Age 13-17), 800L Scale Lot 3 (Age 6-12) |
Primary outcome
GMT of anti SARS-CoV-2 specific neutralizing antibody
Time frame: 28 days after vaccination
GMT of anti SARS-CoV-2 specific neutralizing antibody in all groups (wild type variants test).
13 secondary outcomes
Seroconversion rate of SARS-CoV-2 neutralizing antibody
Time frame: 28 days after vaccination
GMI of SARS-CoV-2 neutralizing antibody
Time frame: 28 days after vaccination
GMT of SARS-CoV-2 S protein RBD antibody
Time frame: 28 days after vaccination
Seroconversion rate of SARS-CoV-2 S protein RBD antibody
Time frame: 28 days after vaccination
GMI of SARS-CoV-2 S protein RBD antibody
Time frame: 28 days after vaccination
GMT of Ad5 vector neutralizing antibody
Time frame: 28 days after vaccination
GMI of Ad5 vector neutralizing antibody
Time frame: 28 days after vaccination
Stratified analysis on Ad5 vector neutralizing antibody
Time frame: 28 days after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
Time frame: Within 30 minutes after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
Time frame: Within 0-7 days after vaccination
Incidence of Adverse Reactions/Events (AE/AR)
Time frame: Within 0-28 days after vaccination
Incidence of Serious Adverse Events (SAE)
Time frame: Within 12 months after vaccination
Incidence of Adverse Events of Special Interest (AESI)
Time frame: Within 12 months after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 37432025Wu YF, Wei MW, Wang RJ, Guo XL, Pan HX, Gao YC, Li XL, Wang X, Ma XM, Wan P, Zhou L, Zhu YW, Li JX, Zhu FC. Immunogenicity consistency and safety with different production scales of recombinant adenovirus type-5 vectored COVID-19 vaccine in healthy adults: a randomized, double-blinded, immunobridging trial. Expert Rev Vaccines. 2023 Jan-Dec;22(1):662-670. doi: 10.1080/14760584.2023.2234997.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fengcai Zhu, MSD principal investigator
Jiangsu Provincal Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml and Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml in people with COVID-19, run by CanSino Biologics Inc. 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 8 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 8 Feb 2023. 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.
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?
GMT of anti SARS-CoV-2 specific neutralizing antibody (time frame: 28 days 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 NCT04916886, 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 8 Feb 2023.