SARS-CoV-2 InfectionNCT04795414
Safety and Immunogenicity of an Inactivated Vaccine Against COVID-19 in Medical Workers
An observational study of SARS-CoV-2 Infection and Covid19, run by Ruijin Hospital at 1 site in China.
Trial summary
With the unprecedented morbidity of the COVID-19 pandemic, the vaccine effectiveness needs to be assessed across diverse populations. The purpose of this study is to evaluate the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in medical workers. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection, Covid19
- What is being tested?
- SARS-CoV-2 Vaccine(Vero Cell), Inactivated
- Type of treatment
- Vaccines
- How many people
- 1,370 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2021to 31 Jan 2023
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Medical workers in Ruijin Hospital who are willing to receive two dose of SARS-CoV-2 inactivated vaccine via intramuscular injection in the arm
Who may be able to join
- Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
- Male or female aged 18-59 years.
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality
ZhiTao YANG, +8613611965436, yangzhitao@hotmail.fr
About this study
With the unprecedented morbidity of the COVID-19 pandemic, the vaccine effectiveness needs to be assessed across diverse populations. The purpose of this study is to evaluate the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in medical workers.
Read the detailed description
1370 participants who were negative for serum-specific antibodies against SARS-CoV-2 at the time of screening were enrolled and were receive a two-dose schedule, 21 days apart, with 4 μg BBIBP-CorV inactivated SARS-CoV-2 vaccine. The primary safety outcome includes solicited local and systemic reactions prompted by and recorded in an electronic diary within 7 days post each injection, unsolicited adverse events and serious adverse events assessed from the receipt of each dose, and clinical laboratory abnormalities from dose 1 through 1month after dose 2. Laboratory tests included measurement of alanine aminotransferase, aspartate aminotransferase, serum total bilirubin, serum albumin, creatinine, blood urea nitrogen, and blood routine examination. Immunogenicity was assessed as the serum anti-SARS-CoV-2 specific antibody responses and neutralizing activity at 4 weeks after the second vaccination.
- Conditions
- SARS-CoV-2 Infection, Covid19
- Being tested
- SARS-CoV-2 Vaccine(Vero Cell), Inactivated
- Keywords
- SARS-CoV-2, Covid19, Inactivated 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.
SARS-CoV-2 Vaccine(Vero Cell), InactivatedBiological
The subjects of Vaccination Group will receive two doses, 21 days apart of inactivated SARS-CoV-2 vaccine (4 μg of BBIBP-CorV)
| Study group | Role | What they receive |
|---|---|---|
| Vaccination Group | Participants vaccinated with inactivated SARS-CoV-2 vaccine are studied for safety and antibody response. Receives: Biological: SARS-CoV-2 Vaccine(Vero Cell), Inactivated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants reporting local reactions
Pain at the injection site, swelling, itch, and redness
Measured: within 7days post each vaccination
Percentage of participants reporting systemic events
Fever, headache, fatigue, nausea, vomiting, diarrhea, constipation, myalgia, arthralgia
Measured: within 7days post each vaccination
Percentage of participants reporting adverse events
verified by investigators
Measured: From Dose 1 through 1 month after Dose 2
Percentage of participants reporting serious adverse events
verified by investigators
Measured: From Dose 1 through 1 month after Dose 2
Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres
determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels
Measured: at 1 month after dose 2
Secondary outcomes (2)
Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres
determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels
Measured: at 6 months after dose 2
Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres
determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels
Measured: at 12 months after dose 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start14 Jan 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion31 Jan 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 SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erzhen Chen, Study director, Ruijin HospitalXinxin Zhang, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04795414
- Sponsor's protocol ID
- RJHKY2021-12
- Status last verified
- Mar 2021
- First submitted
- 11 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yu X, Wei D, Xu W, Liu C, Guo W, Li X, Tan W, Liu L, Zhang X, Qu J, Yang Z, Chen E. Neutralizing activity of BBIBP-CorV vaccine-elicited sera against Beta, Delta and other SARS-CoV-2 variants of concern. Nat Commun. 2022 Apr 4;13(1):1788. doi: 10.1038/s41467-022-29477-0.
PubMed 35379815
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of an Inactivated Vaccine Against COVID-19 in Medical Workers
- ClinicalTrials.gov ID
- NCT04795414
- Acronym / sponsor ID
- RJHKY2021-12
- Conditions
- SARS-CoV-2 Infection, Covid19
- Keywords
- SARS-CoV-2, Covid19, Inactivated vaccine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,370 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 12 Mar 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.
With the unprecedented morbidity of the COVID-19 pandemic, the vaccine effectiveness needs to be assessed across diverse populations. The purpose of this study is to evaluate the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in medical workers.
Detailed description
1370 participants who were negative for serum-specific antibodies against SARS-CoV-2 at the time of screening were enrolled and were receive a two-dose schedule, 21 days apart, with 4 μg BBIBP-CorV inactivated SARS-CoV-2 vaccine. The primary safety outcome includes solicited local and systemic reactions prompted by and recorded in an electronic diary within 7 days post each injection, unsolicited adverse events and serious adverse events assessed from the receipt of each dose, and clinical laboratory abnormalities from dose 1 through 1month after dose 2. Laboratory tests included measurement of alanine aminotransferase, aspartate aminotransferase, serum total bilirubin, serum albumin, creatinine, blood urea nitrogen, and blood routine examination. Immunogenicity was assessed as the serum anti-SARS-CoV-2 specific antibody responses and neutralizing activity at 4 weeks after the second vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vaccination Group | – | Biological: SARS-CoV-2 Vaccine(Vero Cell), InactivatedParticipants vaccinated with inactivated SARS-CoV-2 vaccine are studied for safety and antibody response. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Medical workers in Ruijin Hospital who are willing to receive two dose of SARS-CoV-2 inactivated vaccine via intramuscular injection in the arm
Key inclusion criteria (2 listed)
- Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
- Male or female aged 18-59 years.
Key exclusion criteria (1 listed)
- NA
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(Vero Cell), InactivatedThe subjects of Vaccination Group will receive two doses, 21 days apart of inactivated SARS-CoV-2 vaccine (4 μg of BBIBP-CorV) | Biological | Vaccination Group |
Primary outcome
Percentage of participants reporting local reactions
Time frame: within 7days post each vaccination
Pain at the injection site, swelling, itch, and redness
Percentage of participants reporting systemic events
Time frame: within 7days post each vaccination
Fever, headache, fatigue, nausea, vomiting, diarrhea, constipation, myalgia, arthralgia
Percentage of participants reporting adverse events
Time frame: From Dose 1 through 1 month after Dose 2
verified by investigators
Percentage of participants reporting serious adverse events
Time frame: From Dose 1 through 1 month after Dose 2
verified by investigators
Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres
Time frame: at 1 month after dose 2
determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels
2 secondary outcomes
Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres
Time frame: at 6 months after dose 2
Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres
Time frame: at 12 months after dose 2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Derived from this study: PubMed 35379815Yu X, Wei D, Xu W, Liu C, Guo W, Li X, Tan W, Liu L, Zhang X, Qu J, Yang Z, Chen E. Neutralizing activity of BBIBP-CorV vaccine-elicited sera against Beta, Delta and other SARS-CoV-2 variants of concern. Nat Commun. 2022 Apr 4;13(1):1788. doi: 10.1038/s41467-022-29477-0.
- Individual participant dataSharing planned: Undecided
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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.
Erzhen Chen study director
Ruijin Hospital
Xinxin Zhang principal investigator
Ruijin Hospital
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 SARS-CoV-2 Infection and Covid19, run by Ruijin 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 1 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 19 Mar 2021. 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?
Contact ZhiTao Yang (+8613611965436, yangzhitao@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants reporting local reactions (time frame: within 7days post each vaccination). The study lists 5 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 NCT04795414, 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 19 Mar 2021.