Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential ImmunizationPhase 4NCT05373030
Sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine
A Phase 4 study testing Recombinant adenovirus type-5-vectored COVID-19 vaccine in people with Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential Immunization, run by Zhejiang Provincial Center for Disease Control and Prevention at 1 site in China.
Trial summary
COVID-19 is a novel coronavirus infection caused by respiratory droplets and contact transmission. With the spread of the epidemic, it has become a serious threat to global public health. China has launched a full range of vaccination including the third dose of homologous and sequential booster immunization. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential Immunization
- What is being tested?
- Recombinant adenovirus type-5-vectored COVID-19 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2022to 30 Jun 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers aged 18 and above at the time of screening;
- Obtain the informed consent of the volunteers and sign the informed consent;
- Volunteers are able and willing to comply with the requirements of the clinical trial protocol and complete the 6-month study follow-up;
- Have received 3 doses of Sinovac/Beijing Biological Novel Coronavirus inactivated vaccine with an interval of 6-9 months.
Who cannot join
- Patients with history or family history of convulsion, epilepsy, encephalopathy and mental illness;
- Those who are allergic to any of the components of the study vaccine, have had a severe allergic reaction to the vaccine in the past, a history of allergy or asthma;
- Serious adverse events related to vaccination occurred after previous vaccination; 4) Positive urine pregnancy test in women during lactation or childbearing age;
- 5) Acute febrile disease, infectious disease, SARS history; 6) Axillary body temperature > 37.0℃; 7) Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrolled medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured on site); 8) Patients with serious chronic diseases that are in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid diseases; 9) Congenital or acquired angioedema/neuroedema; 10) Urticaria 1 year before receiving the test vaccine; 11) No spleen or functional no spleen; 12) Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities; 13) History of novel coronavirus infection/illness; 14) Have traveled to medium or high risk areas or left the country in the past 21 days; have a history of novel Coronavirus 2019-epidemiological contact; 15) The researcher made a judgment based on various medical, psychological, social or other conditions that might be contrary to the test protocol or affect the subjects to sign informed consent.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xihu District Center for Disease Control and Prevention
Hangzhou, Zhejiang, 310000
Nani Xu, MsH, xunani2@163.com
About this study
Official title: Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Healthy Adults (18-80 Years Old) Finished 3 Doses Inactivated COVID-19 Vaccine: a Randomised, Double-blind, Parallel Controlled, Clinic Trial
COVID-19 is a novel coronavirus infection caused by respiratory droplets and contact transmission. With the spread of the epidemic, it has become a serious threat to global public health. China has launched a full range of vaccination including the third dose of homologous and sequential booster immunization. To further improve COVID-19 vaccine immunization strategy, we start the clinic research about sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine in Zhejiang province.
- Being tested
- Recombinant adenovirus type-5-vectored COVID-19 vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant adenovirus type-5-vectored COVID-19 vaccineBiological
One dose COVID-19 vaccine
| Study group | Role | What they receive |
|---|---|---|
| Recombinant adenovirus type-5-vectored COVID-19 vaccine | Experimental | Not described Receives: Biological: Recombinant adenovirus type-5-vectored COVID-19 vaccine |
| Inactivated COVID-19 vaccine | Active comparator | Not described Receives: Biological: Recombinant adenovirus type-5-vectored COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse reactions (AR) in 0-14 days after immunization
Incidence of adverse reactions (AR)
Measured: 14 days
Geometric mean titer (GMT) of neutralizing antibody against SARS-COV-2 at 14 days after immunization
Geometric mean titer (GMT) of neutralizing antibody against SARS-COV-2
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start14 May 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
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 Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential ImmunizationStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and Prevention
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373030
- Sponsor's protocol ID
- CS-NCOVIM-ZJ001
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhang H, Xu N, Xu Y, Qin P, Dai R, Xu B, Wang S, Ding L, Fu J, Zhang S, Hua Q, Liao Y, Yang J, Hu X, Jiang J, Lv H. Safety and immunogenicity of Ad5-nCoV immunization after three-dose priming with inactivated SARS-CoV-2 vaccine in Chinese adults. Nat Commun. 2023 Aug 8;14(1):4757. doi: 10.1038/s41467-023-40489-2.
PubMed 37553338
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Healthy Adults (18-80 Years Old) Finished 3 Doses Inactivated COVID-19 Vaccine: a Randomised, Double-blind, Parallel Controlled, Clinic Trial
- ClinicalTrials.gov ID
- NCT05373030
- Acronym / sponsor ID
- CS-NCOVIM-ZJ001
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang Provincial Center for Disease Control and PreventionOther government
- Study start
- 14 May 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 13 May 2022 (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.
COVID-19 is a novel coronavirus infection caused by respiratory droplets and contact transmission. With the spread of the epidemic, it has become a serious threat to global public health. China has launched a full range of vaccination including the third dose of homologous and sequential booster immunization. To further improve COVID-19 vaccine immunization strategy, we start the clinic research about sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine in Zhejiang province.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant adenovirus type-5-vectored COVID-19 vaccine | Experimental | Biological: Recombinant adenovirus type-5-vectored COVID-19 vaccine |
| Inactivated COVID-19 vaccine | Active comparator | Biological: Recombinant adenovirus type-5-vectored COVID-19 vaccine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Volunteers aged 18 and above at the time of screening;
- Obtain the informed consent of the volunteers and sign the informed consent;
- Volunteers are able and willing to comply with the requirements of the clinical trial protocol and complete the 6-month study follow-up;
- Have received 3 doses of Sinovac/Beijing Biological Novel Coronavirus inactivated vaccine with an interval of 6-9 months.
Key exclusion criteria (4 listed)
- Patients with history or family history of convulsion, epilepsy, encephalopathy and mental illness;
- Those who are allergic to any of the components of the study vaccine, have had a severe allergic reaction to the vaccine in the past, a history of allergy or asthma;
- Serious adverse events related to vaccination occurred after previous vaccination; 4) Positive urine pregnancy test in women during lactation or childbearing age;
- 5) Acute febrile disease, infectious disease, SARS history; 6) Axillary body temperature > 37.0℃; 7) Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrolled medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured on site); 8) Patients with serious chronic diseases that are in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid diseases; 9) Congenital or acquired angioedema/neuroedema; 10) Urticaria 1 year before receiving the test vaccine; 11) No spleen or functional no spleen; 12) Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities; 13) History of novel coronavirus infection/illness; 14) Have traveled to medium or high risk areas or left the country in the past 21 days; have a history of novel Coronavirus 2019-epidemiological contact; 15) The researcher made a judgment based on various medical, psychological, social or other conditions that might be contrary to the test protocol or affect the subjects to sign informed consent.
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 adenovirus type-5-vectored COVID-19 vaccineOne dose COVID-19 vaccine | Biological | Inactivated COVID-19 vaccine, Recombinant adenovirus type-5-vectored COVID-19 vaccine |
Primary outcome
Incidence of adverse reactions (AR) in 0-14 days after immunization
Time frame: 14 days
Incidence of adverse reactions (AR)
Geometric mean titer (GMT) of neutralizing antibody against SARS-COV-2 at 14 days after immunization
Time frame: 14 days
Geometric mean titer (GMT) of neutralizing antibody against SARS-COV-2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Derived from this study: PubMed 37553338Zhang H, Xu N, Xu Y, Qin P, Dai R, Xu B, Wang S, Ding L, Fu J, Zhang S, Hua Q, Liao Y, Yang J, Hu X, Jiang J, Lv H. Safety and immunogenicity of Ad5-nCoV immunization after three-dose priming with inactivated SARS-CoV-2 vaccine in Chinese adults. Nat Commun. 2023 Aug 8;14(1):4757. doi: 10.1038/s41467-023-40489-2.
- Individual participant dataSharing planned: Yes
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.
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 Recombinant adenovirus type-5-vectored COVID-19 vaccine in people with Immunogenicity and Safety of a Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine Using for Sequential Immunization, run by Zhejiang Provincial Center 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 4 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 13 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hangjie Zhang, phD (+86-13634159682, hjzhang@cdc.zj.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse reactions (AR) in 0-14 days after immunization (time frame: 14 days). 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 NCT05373030, 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 13 May 2022.