COVID-19NCT05493917
A Real-world Study to Evaluate the Safety and Immunogenicity of a Third-dose Booster After Two Doses of an Inactivated COVID-19 Vaccine
An observational study of COVID-19 and Vaccine Reaction, run by Huashan Hospital at 1 site in China.
Trial summary
This project is a prospective observational real-world study, recruiting and screening subjects who have completed 2 doses of the COVID-19 vaccine for more than 6 months and receive the third dose of the vaccine voluntarily into the clinical cohort of this study. 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, Vaccine Reaction
- What is being tested?
- an inactivated SARS-CoV-2 vaccine named BBIBP-CorV
- Type of treatment
- Vaccines
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Nov 2021to 31 Dec 2022
- Phase
- Observational
- 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
Study population: Recruit and screen subjects who have completed 2 doses of the new coronavirus vaccine for more than 6 months and voluntarily receive a third dose of the vaccine
Who may be able to join
- Age >18 years old, gender is not limited;
- Subjects who completed the second dose of COVID-19 inactivated vaccine for more than 6 months and received the third dose of the same vaccine
Who cannot join
- allergic to the active ingredients of the SARS-CoV-2 vaccine, any of the inactive ingredients, the substances used in the production process, or those who have had allergies during previous vaccination of similar vaccines;
- those who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, respiratory Difficulties, urticaria, angioedema or abdominal pain);
- Receiving other research drugs within 3 months ;participating in other research vaccines Or subjects in clinical trials of research drugs;
- other conditions that the investigator judges are not suitable for this clinical trial;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Infectious department of Huashan Hospital, Fudan University
Shanghai, 200040
Wenhong Zhang, (86)52889999, zhangwenhong@fudan.edu.cn
Jieyu Song, 19921305172, ssjieyu@163.com
About this study
This project is a prospective observational real-world study, recruiting and screening subjects who have completed 2 doses of the COVID-19 vaccine for more than 6 months and receive the third dose of the vaccine voluntarily into the clinical cohort of this study. Subjects received a third dose of the COVID-19 vaccine will be enrolled in the study and followed up for 1 year at baseline (day 0) before vaccine injection, 28 days after injection, 90 days, 270 days after injection. On the 365th day, blood samples were collected for the detection of anti-SARS-CoV-2 antibodies and other related indicators to evaluate the immune protection effect.
- Conditions
- COVID-19, Vaccine Reaction
- Being tested
- an inactivated SARS-CoV-2 vaccine named BBIBP-CorV
- Keywords
- inactive vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an inactivated SARS-CoV-2 vaccine named BBIBP-CorVBiological
Completed 2 doses of an inactivated SARS-CoV-2 vaccine more than 6 months ago and received a third dose of the vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titers (GMTs)
Geometric mean titers (GMTs) of serum COVID-19 neutralizing antibodies
Measured: Day 28±3 after the third dose of vaccine injection
Secondary outcomes (2)
Geometric mean titers (GMTs)
Geometric mean titers (GMTs) of serum COVID-19 neutralizing antibodies
Measured: Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection
IgG
Serum SAS-CoV-2 IgG
Measured: Day 28±3, Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start3 Nov 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493917
- Sponsor's protocol ID
- KY2021-923
- Status last verified
- Aug 2022
- First submitted
- 7 Aug 2022
- Last updated
- 9 Aug 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 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study to Evaluate the Safety and Immunogenicity of a Third-dose Booster After Two Doses of an Inactivated COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05493917
- Acronym / sponsor ID
- KY2021-923
- Conditions
- COVID-19, Vaccine Reaction
- Keywords
- inactive vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Aug 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.
This project is a prospective observational real-world study, recruiting and screening subjects who have completed 2 doses of the COVID-19 vaccine for more than 6 months and receive the third dose of the vaccine voluntarily into the clinical cohort of this study. Subjects received a third dose of the COVID-19 vaccine will be enrolled in the study and followed up for 1 year at baseline (day 0) before vaccine injection, 28 days after injection, 90 days, 270 days after injection. On the 365th day, blood samples were collected for the detection of anti-SARS-CoV-2 antibodies and other related indicators to evaluate the immune protection effect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recruit and screen subjects who have completed 2 doses of the new coronavirus vaccine for more than 6 months and voluntarily receive a third dose of the vaccine
Key inclusion criteria (2 listed)
- Age >18 years old, gender is not limited;
- Subjects who completed the second dose of COVID-19 inactivated vaccine for more than 6 months and received the third dose of the same vaccine
Key exclusion criteria (4 listed)
- allergic to the active ingredients of the SARS-CoV-2 vaccine, any of the inactive ingredients, the substances used in the production process, or those who have had allergies during previous vaccination of similar vaccines;
- those who have had severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, respiratory Difficulties, urticaria, angioedema or abdominal pain);
- Receiving other research drugs within 3 months ;participating in other research vaccines Or subjects in clinical trials of research drugs;
- other conditions that the investigator judges are not suitable for this clinical trial;
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 |
|---|---|---|
| an inactivated SARS-CoV-2 vaccine named BBIBP-CorVCompleted 2 doses of an inactivated SARS-CoV-2 vaccine more than 6 months ago and received a third dose of the vaccine | Biological | – |
Primary outcome
Geometric mean titers (GMTs)
Time frame: Day 28±3 after the third dose of vaccine injection
Geometric mean titers (GMTs) of serum COVID-19 neutralizing antibodies
2 secondary outcomes
Geometric mean titers (GMTs)
Time frame: Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection
IgG
Time frame: Day 28±3, Day 90±7, Day 180±7, Day 270±7, Day 365±7 after the third dose of vaccine injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 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.
Infectious department of Huashan Hospital, Fudan University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Vaccine Reaction, run by Huashan Hospital 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 2 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 9 Aug 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titers (GMTs) (time frame: Day 28±3 after the third dose of vaccine injection). 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 9 Aug 2022.