SARS-CoV2 InfectionPhase 3NCT05164731
Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above
A Phase 3 study testing SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in people with SARS-CoV2 Infection, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV2 Infection
- What is being tested?
- SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 880 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2021to 30 Oct 2022
- Phase
- Phase 3
- 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
- Axillary temperature ≤37.0 ℃.
- aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
- Proven legal identity, could come each visit.
- Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.
Who cannot join
- Persons with a clear history of SARS-CoV-2 infection.
- Using blood products after basic immunization or receiving immunosuppressive therapy.
- Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
- Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
- History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
- Diseases beyond drug control, such as high blood pressure, diabetes, asthma.
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- Those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days.
- Immunization with any vaccine within 14 days.
- Any other situations judged by investigators as not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mile City Centers for Disease Control and Prevention
Mile, Yunnan, 652399
Jianmei Zhou, 0873-6122274
About this study
Official title: Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above After a Two-dose Schedule
To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
- Conditions
- SARS-CoV2 Infection
- Being tested
- SARS-CoV-2 Vaccine, Inactivated (Vero Cell)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SARS-CoV-2 Vaccine, Inactivated (Vero Cell)Biological
the third does was given 3, 4, 5 or 6 months after two doses
| Study group | Role | What they receive |
|---|---|---|
| 3 months after two doses | Experimental | the third does was given 3 months after two doses Receives: Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell) |
| 4 months after two doses | Experimental | the third does was given 4 months after two doses Receives: Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell) |
| 5 months after two doses | Experimental | the third does was given 5 months after two doses Receives: Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell) |
| 6 months after two doses | Experimental | the third does was given 6 months after two doses Receives: Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2
Seroconversion rate of neutralizing antibodies and IgG against SARS-CoV-2 in serum for the third dose immunization schedule
Measured: From 0 days to 6 month after the third dose
SARS-CoV-2 specific memory B and T cell response
SARS-CoV-2 specific memory B and T cell response for the third dose immunization schedule
Measured: From 0 days to 6 month after the third dose
Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Measured: 7 days after vaccination
Adverse reactions/events rate
Occurence of adverse reactions/events after vaccination
Measured: 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start16 Dec 2021
- Primary completion30 Aug 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 880 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Yunnan Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Jingsi Yang, Chinese Academy of Medical Sciences
- Investigators
- Yan Zheng, Principal investigator, Yunnan Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164731
- Sponsor's protocol ID
- 20211102
- Status last verified
- Feb 2022
- First submitted
- 14 Dec 2021
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Third Dose Immunization Schedule of COVID-19 Inactivated Vaccine, (Vero Cells) in Adults Aged 18 Years and Above After a Two-dose Schedule
- ClinicalTrials.gov ID
- NCT05164731
- Acronym / sponsor ID
- 20211102
- Conditions
- SARS-CoV2 Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 880 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Yunnan Center for Disease Control and Prevention
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 21 Dec 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.
To evaluate the immunogenicity and safety of the third dose SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above, who inoculated the third dose after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 3 months after two doses | Experimental | Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)the third does was given 3 months after two doses |
| 4 months after two doses | Experimental | Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)the third does was given 4 months after two doses |
| 5 months after two doses | Experimental | Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)the third does was given 5 months after two doses |
| 6 months after two doses | Experimental | Biological: SARS-CoV-2 Vaccine, Inactivated (Vero Cell)the third does was given 6 months after two doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Axillary temperature ≤37.0 ℃.
- aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of Institute of Medical Biology Chinese Academy of Medical Sciences SARS-CoV-2 inactivated vaccine.
- Proven legal identity, could come each visit.
- Participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form.
Key exclusion criteria (9 listed)
- Persons with a clear history of SARS-CoV-2 infection.
- Using blood products after basic immunization or receiving immunosuppressive therapy.
- Participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination.
- Allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine);
- History of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors.
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 |
|---|---|---|
| SARS-CoV-2 Vaccine, Inactivated (Vero Cell)the third does was given 3, 4, 5 or 6 months after two doses | Biological | 3 months after two doses, 4 months after two doses, 5 months after two doses, 6 months after two doses |
Primary outcome
Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2
Time frame: From 0 days to 6 month after the third dose
Seroconversion rate of neutralizing antibodies and IgG against SARS-CoV-2 in serum for the third dose immunization schedule
SARS-CoV-2 specific memory B and T cell response
Time frame: From 0 days to 6 month after the third dose
SARS-CoV-2 specific memory B and T cell response for the third dose immunization schedule
Adverse reactions/events rate
Time frame: 7 days after vaccination
Occurence of adverse reactions/events after vaccination
Adverse reactions/events rate
Time frame: 28 days after vaccination
Occurence of adverse reactions/events after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Yan Zheng principal investigator
Yunnan 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 Phase 3 study testing SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in people with SARS-CoV2 Infection, run by Chinese Academy of Medical Sciences 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 9 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 16 Feb 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jingsi Yang, Master (86-0871-68334551, yjs@imbcams.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate of Neutralizing and IgG antibodies against SARS-CoV-2 (time frame: From 0 days to 6 month after the third dose). The study lists 4 primary outcomes in all. 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 16 Feb 2022.