COVID-19Phase 3NCT04659239
The Efficacy, Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
A Phase 3 study testing Inactivated SARS-CoV-2 Vaccine (Vero cell) in people with COVID-19, run by Chinese Academy of Medical Sciences at 2 sites in 2 countries.
Trial summary
This is a randomized, double-blinded, placebo controlled phase III clinical trial to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after 2-dose schedule. 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?
- Inactivated SARS-CoV-2 Vaccine (Vero cell)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34,020 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Jan 2021to Jul 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
- Adults aged 18 years and above (including boundary values), both female and male.
- Legal identification of the participants shall be provided.
- Participants shall understand the content in the Informed Consent Form (ICF) and the vaccine for administration, sign the ICF voluntarily and are capable of using thermometers and rulers, and filling in diary cards and contact cards as per the requirements.
- Subject shall be able to communicate well with investigators, understand and comply with the requirements of this study.
- Participants with oral temperature ≤ 37.9 ℃.
- Female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile [i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive OR consistently use any of the following methods of contraception:
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- Condoms (male or female)
- Diaphragm with spermicide
- Cervical cap with spermicide
- Intrauterine device
- Oral or patch contraceptives
- Any country regulatory-approved contraceptive method that is designed to protect against pregnancy
- Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle (other approaches to abstinence are not acceptable).
Who cannot join
- Contraindications to commonly used vaccines;
- History of allergy to any vaccines or drug;
- Received any vaccine within 1 month before the first dose of vaccination；
- Serious diseases required to be excluded, including but not limited to history of diseases in nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other systems, and a history of malignant tumors;
- Before immunizing the first dose of investigational vaccine, those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days;
- Those who have a hereditary bleeding tendency or blood coagulation dysfunction, or a history of thrombosis or hemorrhagic disease；
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- Surgical removal of whole or part of spleen for any reason；
- Those who have undergone surgery within 3 months before signing the ICF or those who plan to undergo surgery during or within 3 months after completion of the trial (including plastic surgery, dental and oral surgery);
- Those who donated or lost blood (≥400 mL) in the past 3 months, who received blood transfusion or use of blood products, or who plan blood donation during the trial;
- Those who received other investigational or unregistered products (drugs, vaccines, biological product or devices) in the past 3 months before signing the ICF, or plan to use them during the study.
- Those who received immunosuppressant therapy within 6 months before signing the ICF, such as long-term systemic glucocorticoid treatment (with systemic glucocorticoid therapy for more than 2 consecutive weeks within 6 months, such as prednisone or similar drugs), but local administration is permitted (such as ointment, eye drops, inhalants, or nasal spray). The local administration should not exceed the recommended dose in the package insert or have any signs of systemic exposure;
- Participants cannot meet the criteria through the comprehensive physical examination, mainly including:
- Abnormal vital signs with clinical significance (awakening heart rate <55 beats/min or >100 beats/min, systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
- Those who tested positive for type 1 or type 2 human immunodeficiency virus (HIV-1/2) antibody, or SARS-CoV-2 nucleic acid;
- History of COVID-19;
- Participants who have a positive pregnancy test, or are breastfeeding, or planning pregnancy, or plan to donate sperm or eggs within 12 months from the screening period to the whole-course immunization;
- Participants who are considered as inappropriate for the trial by investigators.
- Suspected or known current alcohol or drug dependency.
- Investigator site personnel directly related to this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Double-Blinded, Placebo Controlled Phase III Clinical Trial of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Adults Aged 18 Years and Above
This is a randomized, double-blinded, placebo controlled phase III clinical trial to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after 2-dose schedule.
Read the detailed description
The trial includes two parts, namely the efficacy study and immunogenicity bridging study. A total of 34020 participants will be enrolled, i.e. 32820 for efficacy cohort, and 1200 for domestic immunogenicity cohort in China.
Efficacy study: Participants will be randomly inoculated with two doses of investigational vaccine or placebo according to 1:1 ratio following Day 0-Day 14 immunization schedule and will be observed from the first dose of investigational vaccine to collect symptomatic and laboratory-confirmed COVID-19 cases for the evaluation of the efficacy of the investigational vaccine.
Immunogenicity bridging study: Before inoculating the first dose, 14 days, 6 months and 12 months after the whole-course immunization, blood samples will be taken for determination of neutralizing antibody and IgG antibody against SARS-CoV-2 (ELISA method); and before inoculating the first dose, 6 months and 12 months after the whole-course immunization, blood samples will be taken for detecting specific T cells with the ELISPOT assay with an aim to evaluate immunogenicity and immune persistence.
Safety observations for all participants will be conducted from the first dose to 28 days after the whole-course immunization, and follow-up of SAEs will also be conducted from the first dose to at least 12 months after the whole-course immunization to evaluate the safety of the investigational vaccine.
- Conditions
- COVID-19
- Being tested
- Inactivated SARS-CoV-2 Vaccine (Vero cell), Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated SARS-CoV-2 Vaccine (Vero cell)Biological
The inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.
PlaceboBiological
The placebo was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Vaccine | Experimental | Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) according to the immunization schedule of D0, D14. Receives: Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) |
| Placebo | Placebo comparator | Participants will receive 2 doses of the placebo according to the immunization schedule of D0, D14. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of COVID-19 cases after two-doses of vaccination
The incidence of the symptomatic and laboratory-confirmed COVID-19 cases starting from Day 14 after the second dose.
Measured: From 14 days after the second dose to 1 year after the second dose.
The incidence of solicited AEs.
The incidence of solicited AEs at the inoculation site (local) and solicited AEs at the non-inoculation site (systemic) within 7 days after each dose
Measured: 7 days after each dose
Secondary outcomes (15)
The incidence of COVID-19 cases after at least one dose of immunization.
The incidence of the symptomatic and laboratory-confirmed COVID-19 cases after at least one dose of immunization.
Measured: From the first dose to 1 year after the second dose.
The Geometric Mean Titer (GMT) of neutralizing antibody
The Geometric Mean Titer (GMT) of neutralizing antibody against SARS-CoV-2 14 days after the whole-course immunization.
Measured: 14 days after the whole-course immunization
The Geometric Mean Titer (GMT) of IgG antibody
The Geometric Mean Titer (GMT) of IgG antibody (ELISA method) against SARS-CoV-2 14 days after the whole-course immunization.
Measured: 14 days after the whole-course immunization
The positive rates of neutralizing antibody
The positive rates of neutralizing antibody against SARS-CoV-2 14 days after the whole-course immunization.
Measured: 14 days after the whole-course immunization
The positive rates of IgG antibody
The positive rates of IgG antibody (ELISA method) against SARS-CoV-2 14 days after the whole-course immunization.
Measured: 14 days after the whole-course immunization
The seroconversion rates of neutralizing antibody
The seroconversion rates of neutralizing antibody against SARS-CoV-2 14 days after the whole-course immunization.
Measured: 14 days after the whole-course immunization
The seroconversion rates of IgG antibody
The seroconversion rates of IgG antibody (ELISA method) against SARS-CoV-2 14 days after the whole-course immunization.
Measured: 14 days after the whole-course immunization
The positive rates of neutralizing antibody
The positive rates of neutralizing antibody against SARS-CoV-2 6 months and 12 months after whole-course immunization.
Measured: 6 months and 12 months after whole-course immunization.
The positive rates of IgG antibody
The positive rates of IgG antibody (ELISA method) against SARS-CoV-2 6 months and 12 months after whole-course immunization.
Measured: 6 months and 12 months after whole-course immunization.
The Geometric Mean Titer (GMT) of neutralizing antibody
The Geometric Mean Titer (GMT) of neutralizing antibody against SARS-CoV-2 6 months and 12 months after whole-course immunization.
Measured: 6 months and 12 months after whole-course immunization.
The Geometric Mean Titer (GMT) of IgG antibody
The Geometric Mean Titer (GMT) of IgG antibody (ELISA method) against SARS-CoV-2 6 months and 12 months after whole-course immunization.
Measured: 6 months and 12 months after whole-course immunization.
Specific T cells with ELISPOT assay
Detecting specific T cells with ELISPOT assay 6 months and 12 months after the whole-course immunization
Measured: 6 months and 12 months after the whole-course immunization
The incidence of AEs
The incidence of AEs from the first dose to 28 days after whole-course immunization
Measured: From the first dose to 28 days after whole-course immunization.
The incidence of SAEs
The incidence of SAEs from the first dose to at least 12 months after whole-course immunization.
Measured: From the first dose to at least 12 months after whole-course immunization.
The occurrence of Antibody Dependent Enhancement (ADE)/ Vaccine Enhanced Disease(VED)
The occurrence of Antibody Dependent Enhancement (ADE)/ Vaccine Enhanced Disease(VED) that probably related to the laboratory-confirmed COVID-19 from 14 days after the second dose till the end of trial.
Measured: From 14 days after the second dose to 1 year after the second dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start28 Jan 2021
- Primary completionSep 2021 (estimated)
- Study completionJul 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34,020 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qihan Li, Chinese Academy of Medical Sciences
- Investigators
- Yasmin binti Mohamed Gani, PhD, Principal investigator, Hospital Sungai BulohAdilson JW Cavalcante, PhD, Principal investigator, CEMEC Pesquisa Clinica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659239
- Sponsor's protocol ID
- 20200404
- Status last verified
- Feb 2021
- First submitted
- 5 Dec 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo Controlled Phase III Clinical Trial of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Adults Aged 18 Years and Above
- ClinicalTrials.gov ID
- NCT04659239
- Acronym / sponsor ID
- 20200404
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34,020 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 9 Dec 2020 (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 randomized, double-blinded, placebo controlled phase III clinical trial to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in adults aged 18 years and above after 2-dose schedule.
Detailed description
The trial includes two parts, namely the efficacy study and immunogenicity bridging study. A total of 34020 participants will be enrolled, i.e. 32820 for efficacy cohort, and 1200 for domestic immunogenicity cohort in China.
Efficacy study: Participants will be randomly inoculated with two doses of investigational vaccine or placebo according to 1:1 ratio following Day 0-Day 14 immunization schedule and will be observed from the first dose of investigational vaccine to collect symptomatic and laboratory-confirmed COVID-19 cases for the evaluation of the efficacy of the investigational vaccine.
Immunogenicity bridging study: Before inoculating the first dose, 14 days, 6 months and 12 months after the whole-course immunization, blood samples will be taken for determination of neutralizing antibody and IgG antibody against SARS-CoV-2 (ELISA method); and before inoculating the first dose, 6 months and 12 months after the whole-course immunization, blood samples will be taken for detecting specific T cells with the ELISPOT assay with an aim to evaluate immunogenicity and immune persistence.
Safety observations for all participants will be conducted from the first dose to 28 days after the whole-course immunization, and follow-up of SAEs will also be conducted from the first dose to at least 12 months after the whole-course immunization to evaluate the safety of the investigational vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Vaccine | Experimental | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell)Participants will receive 2 doses of the inactivated SARS-CoV-2 vaccine (Vero cell) according to the immunization schedule of D0, D14. |
| Placebo | Placebo comparator | Biological: PlaceboParticipants will receive 2 doses of the placebo according to the immunization schedule of D0, D14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults aged 18 years and above (including boundary values), both female and male.
- Legal identification of the participants shall be provided.
- Participants shall understand the content in the Informed Consent Form (ICF) and the vaccine for administration, sign the ICF voluntarily and are capable of using thermometers and rulers, and filling in diary cards and contact cards as per the requirements.
- Subject shall be able to communicate well with investigators, understand and comply with the requirements of this study.
- Participants with oral temperature ≤ 37.9 ℃.
Key exclusion criteria (19 listed)
- Contraindications to commonly used vaccines;
- History of allergy to any vaccines or drug;
- Received any vaccine within 1 month before the first dose of vaccination；
- Serious diseases required to be excluded, including but not limited to history of diseases in nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other systems, and a history of malignant tumors;
- Before immunizing the first dose of investigational vaccine, those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days;
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 |
|---|---|---|
| Inactivated SARS-CoV-2 Vaccine (Vero cell)The inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use. | Biological | Investigational Vaccine |
| PlaceboThe placebo was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use. | Biological | Placebo |
Primary outcome
The incidence of COVID-19 cases after two-doses of vaccination
Time frame: From 14 days after the second dose to 1 year after the second dose.
The incidence of the symptomatic and laboratory-confirmed COVID-19 cases starting from Day 14 after the second dose.
The incidence of solicited AEs.
Time frame: 7 days after each dose
The incidence of solicited AEs at the inoculation site (local) and solicited AEs at the non-inoculation site (systemic) within 7 days after each dose
15 secondary outcomes
The incidence of COVID-19 cases after at least one dose of immunization.
Time frame: From the first dose to 1 year after the second dose.
The Geometric Mean Titer (GMT) of neutralizing antibody
Time frame: 14 days after the whole-course immunization
The Geometric Mean Titer (GMT) of IgG antibody
Time frame: 14 days after the whole-course immunization
The positive rates of neutralizing antibody
Time frame: 14 days after the whole-course immunization
The positive rates of IgG antibody
Time frame: 14 days after the whole-course immunization
The seroconversion rates of neutralizing antibody
Time frame: 14 days after the whole-course immunization
The seroconversion rates of IgG antibody
Time frame: 14 days after the whole-course immunization
The positive rates of neutralizing antibody
Time frame: 6 months and 12 months after whole-course immunization.
The positive rates of IgG antibody
Time frame: 6 months and 12 months after whole-course immunization.
The Geometric Mean Titer (GMT) of neutralizing antibody
Time frame: 6 months and 12 months after whole-course immunization.
The Geometric Mean Titer (GMT) of IgG antibody
Time frame: 6 months and 12 months after whole-course immunization.
Specific T cells with ELISPOT assay
Time frame: 6 months and 12 months after the whole-course immunization
The incidence of AEs
Time frame: From the first dose to 28 days after whole-course immunization.
The incidence of SAEs
Time frame: From the first dose to at least 12 months after whole-course immunization.
The occurrence of Antibody Dependent Enhancement (ADE)/ Vaccine Enhanced Disease(VED)
Time frame: From 14 days after the second dose to 1 year after the second dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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.
Yasmin binti Mohamed Gani, PhD principal investigator
Hospital Sungai Buloh
Adilson JW Cavalcante, PhD principal investigator
CEMEC Pesquisa Clinica
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inactivated SARS-CoV-2 Vaccine (Vero cell) in people with COVID-19, run by Chinese Academy of Medical Sciences at 2 sites in 2 countries.
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 13 inclusion and 19 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 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil, Malaysia. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of COVID-19 cases after two-doses of vaccination (time frame: From 14 days after the second dose to 1 year after the second dose.). 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?
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 10 Feb 2021.