COVID-19Phase 4NCT05855408
Effectiveness of a Second COVID-19 Vaccine Booster in Chinese Adults
A Phase 4 study testing Intramuscularly administered Ad5-nCoV vaccine, Aerosolized Ad5-nCoV and DelNS1-2019-nCoV-RBD-OPT1 in people with COVID-19, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
This is a multicenter, parallel groups, partially randomized, open-label, blank-controlled adaptive platform study to evaluate the effectiveness of a second COVID-19 vaccine booster in Chinese adults who are charactered as the majority of whom with hybrid immunity of COVID-19 vaccination and COVID-19 breakthrough… 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?
- Intramuscularly administered Ad5-nCoV vaccine, Aerosolized Ad5-nCoV and DelNS1-2019-nCoV-RBD-OPT1
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 18 May 2023to 31 Dec 2024
- 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
- Adults aged 18 years and over, including the elderly over 60 years and those with underlying diseases.
- Volunteers are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.
- ≥ 4 months from the last SARS-CoV-2 infection (or never been infected), and 6 months or more from the first booster immunization of the COVID-19 vaccine.
Who cannot join
- Volunteers have suspected symptoms of COVID-19 when enrolled, such as dry throat, sore throat, cough, etc.
- The COVID-19 Antigen Quick Test Kit is positive when volunteers are enrolled.
- Fever, temperature > 37.0°C.
- Have received a second COVID-19 vaccine booster immunization.
- Have a history of serious adverse reactions related to the vaccine and/or have a history of severe allergic reactions to any component of the investigational vaccine (only applicable to the vaccine groups).
- Pregnant or lactating women.
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- HIV infection, tuberculosis, low immunity caused by disease or long-term medication.
- Acute disease or acute onset of chronic disease.
- Epilepsy and other progressive neurological disorders.
- Other situations that are not suitable for participating in this research, according to the judgment of the researcher.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, 210009
Jing-Xin Li, PhD, 86-25-83759913, jingxin42102209@126.com
About this study
Official title: Effectiveness of a Second COVID-19 Vaccine Booster in Chinese Adults Aged 18 Years or Above: a Multicenter, Parallel Groups, Partially Randomized, Open-label, Blank-controlled Adaptive Platform Trial
This is a multicenter, parallel groups, partially randomized, open-label, blank-controlled adaptive platform study to evaluate the effectiveness of a second COVID-19 vaccine booster in Chinese adults who are charactered as the majority of whom with hybrid immunity of COVID-19 vaccination and COVID-19 breakthrough infection. Individuals aged 18 years and over, include the elderly over 60 years old or those with underlying diseases (history of underlying medical conditions diagnosed by a clinician, including hypertension, diabetes, heart disease, etc). The eligible participants with an interval ≥ 4 months after previous SARS-CoV-2 infection (or had never been infected) and ≥ 6 months from the first COVID-19 vaccine booster will be recruited. Participants who are not willing to receive the second booster but are consent to participate the surveillance for COVID-19, will be included as a blank control. Informed consent will be acquired from eligible participants. Other participants who are willing to receive the second booster and participate the surveillance for COVID-19, will be randomly allocated in a ratio of 1: k (k is the number of vaccine types) to the different investigational vaccines, stratified according to age and history of COVID-19 infection. The symptomatic COVID-19 cases will be reported and documented in both the investigational and control groups. The occurrence of serious adverse events within 6 months after vaccination will be observed. Moreover, blood and nasal mucosa samples will be collected on the day 0 before and day 14, month 3 and 6 after the booster vaccination in a subgroup for humoral, cellular and mucosal immunogenicity analysis. Moreover, oral specimens will be collected once for all participants on the day of enrollment.
- Conditions
- COVID-19
- Being tested
- Intramuscularly administered Ad5-nCoV vaccine, Aerosolized Ad5-nCoV, DelNS1-2019-nCoV-RBD-OPT1, SYS6006
- Keywords
- SARS-CoV-2, effectiveness, hybrid immunity, booster immunization, adaptive platform trial
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramuscularly administered Ad5-nCoV vaccineBiological
This vaccine is produced by CanSino Biologics Inc.
Aerosolized Ad5-nCoVBiological
This vaccine is produced by CanSino Biologics Inc.
DelNS1-2019-nCoV-RBD-OPT1Biological
This vaccine is produced by Wantai Biopharmaceutical Company.
SYS6006Biological
This vaccine is produced by CSPC Pharmaceutical Group Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Subjects are assigned to receive one dose of intramuscularly administered Ad5-nCoV vaccine as the second booster. Receives: Biological: Intramuscularly administered Ad5-nCoV vaccine |
| Group 2 | Experimental | Subjects are assigned to receive one dose of aerosolized Ad5-nCoV vaccine as the second booster. Receives: Biological: Aerosolized Ad5-nCoV |
| Group 3 | Experimental | Subjects are assigned to receive two doses of DelNS1-2019-nCoV-RBD-OPT1 vaccine as the second booster. Receives: Biological: DelNS1-2019-nCoV-RBD-OPT1 |
| Group 4 | Experimental | Subjects are assigned to receive one dose of SYS6006 vaccine as the second booster. Receives: Biological: SYS6006 |
| Group 5 | No intervention | Subjects are not assigned any vaccines served as a blank control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of COVID-19 from 14 days to 6 months after the booster immunization.
Measured: from 14 days to 6 months after the booster dose
Secondary outcomes (18)
The incidence of COVID-19 from 7 days to 6 months after the booster immunization.
Measured: from 7 days to 6 months the booster dose
The incidence of COVID-19 from 28 days to 6 months after the booster immunization.
Measured: from 28 days to 6 months the booster dose
The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 7 days to 6 months after the booster immunization.
Measured: from 7 days to 6 months the booster dose
The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 14 days to 6 months after the booster immunization.
Measured: from 14 days to 6 months the booster dose
The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 28 days to 6 months after the booster immunization.
Measured: from 28 days to 6 months the booster dose
The incidence of hospitalized COVID-19 from 7 days to 6 months after the booster immunization.
Measured: from 7 days to 6 months the booster dose
The incidence of hospitalized COVID-19 from 14 days to 6 months after the booster immunization.
Measured: from 14 days to 6 months the booster dose
The incidence of hospitalized COVID-19 from 28 days to 6 months after the booster immunization.
Measured: from 28 days to 6 months the booster dose
Geometric mean titer (GMT), Geometric mean fold increase (GMFI) and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.
Measured: On day 14 after the booster vaccination
GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.
Measured: On month 3 after the booster vaccination
GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.
Measured: On month 6 after the booster vaccination
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.
Measured: On day 14 after the booster vaccination
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.
Measured: On month 3 after the booster vaccination
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.
Measured: On month 6 after the booster vaccination
GMT, GMFI and seroconversion of nasal specific IgA antibodies on day 14 after the booster vaccination in the immunogenic subgroup.
Measured: On day 14 after the booster vaccination
GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 3 after the booster vaccination in the immunogenic subgroup.
Measured: On month 3 after the booster vaccination
GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 6 after the booster vaccination in the immunogenic subgroup.
Measured: On month 6 after the booster vaccination
The incidence of serious adverse events within 6 months after the 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.
- First posted11 May 2023
- Study start18 May 2023 (estimated)
- Primary completion18 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jing-Xin Li, PhD, Principal investigator, Jiangsu Provincial Center for Diseases Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855408
- Sponsor's protocol ID
- JSVCT178
- Status last verified
- May 2023
- First submitted
- 10 May 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Second COVID-19 Vaccine Booster in Chinese Adults Aged 18 Years or Above: a Multicenter, Parallel Groups, Partially Randomized, Open-label, Blank-controlled Adaptive Platform Trial
- ClinicalTrials.gov ID
- NCT05855408
- Acronym / sponsor ID
- JSVCT178
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, effectiveness, hybrid immunity, booster immunization, adaptive platform trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Study start
- 18 May 2023 (estimated)
- Primary completion
- 18 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 May 2023 (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.
This is a multicenter, parallel groups, partially randomized, open-label, blank-controlled adaptive platform study to evaluate the effectiveness of a second COVID-19 vaccine booster in Chinese adults who are charactered as the majority of whom with hybrid immunity of COVID-19 vaccination and COVID-19 breakthrough infection. Individuals aged 18 years and over, include the elderly over 60 years old or those with underlying diseases (history of underlying medical conditions diagnosed by a clinician, including hypertension, diabetes, heart disease, etc). The eligible participants with an interval ≥ 4 months after previous SARS-CoV-2 infection (or had never been infected) and ≥ 6 months from the first COVID-19 vaccine booster will be recruited. Participants who are not willing to receive the second booster but are consent to participate the surveillance for COVID-19, will be included as a blank control. Informed consent will be acquired from eligible participants. Other participants who are willing to receive the second booster and participate the surveillance for COVID-19, will be randomly allocated in a ratio of 1: k (k is the number of vaccine types) to the different investigational vaccines, stratified according to age and history of COVID-19 infection. The symptomatic COVID-19 cases will be reported and documented in both the investigational and control groups. The occurrence of serious adverse events within 6 months after vaccination will be observed. Moreover, blood and nasal mucosa samples will be collected on the day 0 before and day 14, month 3 and 6 after the booster vaccination in a subgroup for humoral, cellular and mucosal immunogenicity analysis. Moreover, oral specimens will be collected once for all participants on the day of enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: Intramuscularly administered Ad5-nCoV vaccineSubjects are assigned to receive one dose of intramuscularly administered Ad5-nCoV vaccine as the second booster. |
| Group 2 | Experimental | Biological: Aerosolized Ad5-nCoVSubjects are assigned to receive one dose of aerosolized Ad5-nCoV vaccine as the second booster. |
| Group 3 | Experimental | Biological: DelNS1-2019-nCoV-RBD-OPT1Subjects are assigned to receive two doses of DelNS1-2019-nCoV-RBD-OPT1 vaccine as the second booster. |
| Group 4 | Experimental | Biological: SYS6006Subjects are assigned to receive one dose of SYS6006 vaccine as the second booster. |
| Group 5 | No intervention | –Subjects are not assigned any vaccines served as a blank control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 years and over, including the elderly over 60 years and those with underlying diseases.
- Volunteers are able and willing to comply with the requirements of the clinical trial protocol and sign the informed consent form.
- ≥ 4 months from the last SARS-CoV-2 infection (or never been infected), and 6 months or more from the first booster immunization of the COVID-19 vaccine.
Key exclusion criteria (10 listed)
- Volunteers have suspected symptoms of COVID-19 when enrolled, such as dry throat, sore throat, cough, etc.
- The COVID-19 Antigen Quick Test Kit is positive when volunteers are enrolled.
- Fever, temperature > 37.0°C.
- Have received a second COVID-19 vaccine booster immunization.
- Have a history of serious adverse reactions related to the vaccine and/or have a history of severe allergic reactions to any component of the investigational vaccine (only applicable to the vaccine groups).
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 |
|---|---|---|
| Intramuscularly administered Ad5-nCoV vaccineThis vaccine is produced by CanSino Biologics Inc. | Biological | Group 1 |
| Aerosolized Ad5-nCoVThis vaccine is produced by CanSino Biologics Inc. | Biological | Group 2 |
| DelNS1-2019-nCoV-RBD-OPT1This vaccine is produced by Wantai Biopharmaceutical Company. | Biological | Group 3 |
| SYS6006This vaccine is produced by CSPC Pharmaceutical Group Co., Ltd. | Biological | Group 4 |
Primary outcome
The incidence of COVID-19 from 14 days to 6 months after the booster immunization.
Time frame: from 14 days to 6 months after the booster dose
18 secondary outcomes
The incidence of COVID-19 from 7 days to 6 months after the booster immunization.
Time frame: from 7 days to 6 months the booster dose
The incidence of COVID-19 from 28 days to 6 months after the booster immunization.
Time frame: from 28 days to 6 months the booster dose
The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 7 days to 6 months after the booster immunization.
Time frame: from 7 days to 6 months the booster dose
The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 14 days to 6 months after the booster immunization.
Time frame: from 14 days to 6 months the booster dose
The incidence of graded COVID-19 (mild, moderate, severe, critical or death) from 28 days to 6 months after the booster immunization.
Time frame: from 28 days to 6 months the booster dose
The incidence of hospitalized COVID-19 from 7 days to 6 months after the booster immunization.
Time frame: from 7 days to 6 months the booster dose
The incidence of hospitalized COVID-19 from 14 days to 6 months after the booster immunization.
Time frame: from 14 days to 6 months the booster dose
The incidence of hospitalized COVID-19 from 28 days to 6 months after the booster immunization.
Time frame: from 28 days to 6 months the booster dose
Geometric mean titer (GMT), Geometric mean fold increase (GMFI) and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.
Time frame: On day 14 after the booster vaccination
GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 3 after the booster vaccination
GMT, GMFI and seroconversion of neutralizing antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 6 after the booster vaccination
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on day 14 after the booster vaccination in the immunogenic subgroup.
Time frame: On day 14 after the booster vaccination
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 3 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 3 after the booster vaccination
GMT, GMFI and seroconversion of S-RBD-specific IgG antibodies against wild-type SARS-CoV-2 and omicron variant on month 6 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 6 after the booster vaccination
GMT, GMFI and seroconversion of nasal specific IgA antibodies on day 14 after the booster vaccination in the immunogenic subgroup.
Time frame: On day 14 after the booster vaccination
GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 3 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 3 after the booster vaccination
GMT, GMFI and seroconversion of nasal specific IgA antibodies on month 6 after the booster vaccination in the immunogenic subgroup.
Time frame: On month 6 after the booster vaccination
The incidence of serious adverse events within 6 months after the booster vaccination.
Time frame: within 6 months after the booster dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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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.
Jing-Xin Li, PhD principal investigator
Jiangsu Provincial Center for Diseases 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 Phase 4 study testing Intramuscularly administered Ad5-nCoV vaccine, Aerosolized Ad5-nCoV and DelNS1-2019-nCoV-RBD-OPT1 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 22 May 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing-Xin Li, PhD (86-25-83759913, jingxin42102209@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of COVID-19 from 14 days to 6 months after the booster immunization. (time frame: from 14 days to 6 months after the booster dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2023.