COVID-19Phase 1/2NCT05313022
Safety and Immunogenicity of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19
A Phase 1/2 study testing ZR-202-CoV in people with COVID-19, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in China.
Trial summary
The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and immunogenicity of ZR-202-CoV, administered as 2 injections (i.m) at 28 days apart in adult subjects 60 years of age and above. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- ZR-202-CoV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2022to Jun 2023
- Phase
- Phase 1/2
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having understood the contents of the clinical study and ICF, and having signed the ICF.
- Adults of both genders, 60 years of age and older.
- Adults who can provide legal proof of identity.
- SARS-COV-2 antibody screening negative at screening visit.
Who cannot join
- Having a clear or suspected allergy to the test vaccine ingredients (including S protein, aluminum hydroxide adjuvant or CpG adjuvant), or have a history of severe allergy to any previous vaccine (such as acute allergic reaction, dyspnea or angioneurotic edema, etc.) (inquiries);
- Having a history of SARS or MERS infection, or a previous infection of COVID-19 (previous nucleic acid or serum antibody test was positive) (inquiries);
- Previous vaccination with SARS-CoV-2 vaccine(including SARS-CoV-2 vaccine for clinical trial) or received other vaccines within 28 days prior to the first dose of vaccine;
- Abnormal skin (such as inflammation, induration, redness and swelling, large area scar, etc.) on both sides of the arm at the vaccination site and affecting the vaccination or safety observation(examination);
- Axillary body temperature ≥37.3℃ before the first dose vaccination(examination);
- Safety laboratory abnormal of any of the below:
Show all 18Show fewer
- Liver function: ALT or ALT > 1.25*ULN
- Kidney function: serum creatinine (Cr) > ULN
- Glycated hemoglobin (HbA1c) ≥ 8.0%
- Uncontrolled epilepsy or other progressive neurological diseases (inquiries);
- Immunocompromised or have been diagnosed with Human Immunodeficiency Virus (HIV) infection, lymphoma, leukemia, Systemic lupus erythematosus, SLE, rheumatoid arthritis, inflammatory bowel disease or other autoimmune diseases (inquiries);
- Asplenia or functional asplenia (inquiries);
- Having a history of coagulation disorder or abnormal coagulation function (e.g., lack of coagulation factors or thrombocytopenia) and assessed by investigators that are not suitable for the study (inquiry);
- Having malignant tumor that not been cured clinically and been assessed by investigators as not suitable for the study (inquiry);
- Having acute diseases or acute onset or poorly controlled chronic diseases(e.g. hypertension patients with blood pressure > 160/100mmHg, diabetes patients with ketoacidosis, etc.) within 14 days before the first dose vaccination and assessed by investigators as not suitable for the study (inquiry);
- Use of systemic drugs that affect immune function within 6 months prior to the first dose vaccination for a long time (more than 14 consecutive days), such as immunosuppressant, cytotoxic drugs, inhaled corticosteroids (not including allergic rhinitis treated with corticosteroid spray), unless the investigators determines that the drug will not interfere with, limit, or obfuscate the evaluation prescribed by the protocol, or may endanger the safety of the subject (inquiry);
- Treatment with whole blood, plasma or immunoglobulin within 3 months prior to the first dose(inquiry);
- Any other factors that, in the investigator's judgment, are inappropriate for participation in the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Immunogenicity and Safety of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy Adults Aged 60 Years and Above
The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and immunogenicity of ZR-202-CoV, administered as 2 injections (i.m) at 28 days apart in adult subjects 60 years of age and above.
- Conditions
- COVID-19
- Being tested
- ZR-202-CoV, 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.
ZR-202-CoVBiological
Adjuvanted Recombinant SARS-CoV-2 S-protein Subunit Vaccine
PlaceboOther
Normal saline solution
| Study group | Role | What they receive |
|---|---|---|
| ZR-202-CoV | Experimental | Adult healthy subjects (60 years of age above, inclusive) receive ZR-202-CoV at Day 0 and Day 28 Receives: Biological: ZR-202-CoV |
| Placebo | Placebo comparator | Adult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody
Measured: 28 days after each dose
Proportion of participants achieving seroconversion for SARS-CoV-2 neutralising antibody
Measured: 28 days after each dose
Geometric mean increase (GMI) of SARS-CoV-2 neutralising antibodies
Measured: 28 days after each dose
Geometric mean titer (GMT) of SARS-CoV-2 specific IgG binding antibodies.
Measured: 28 days after each dose
Proportion of participants achieving seroconversion for SARS-CoV-2 specific IgG binding antibodies..
Measured: 28 days after each dose
Geometric mean increase (GMI) of SARS-CoV-2 specific IgG binding antibodies.
Measured: 28 days after each dose
Secondary outcomes (5)
Incidence of adverse events (AEs) after vaccination
Percentage of participants with AEs for 28 days following each vaccination (Days 0, 28) by intensity, relevance.
Measured: 28 days after the first or second vaccination
Incidence of solicited adverse events (AEs) after vaccination
Percentage of participants with solicited AEs for 30 minutes and 7 days following each vaccination (Days 0, 28) by intensity, relevance
Measured: 30 minutes and 7 days after the first or second vaccination
Incidence of unsolicited adverse events (AEs) after vaccination
Percentage of participants with unsolicited AEs for 28 days following each vaccination (Days 0, 28) by intensity, relevance.
Measured: 28 days after the first or second vaccination
Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis, thyroid and coagulation parameters
Safety Laboratory Values (Serum Chemistry, Hematology)
Measured: Day 4 after first or second vaccination
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
Percentage of participants with SAEs or AESIs for 12month after last dose vaccination
Measured: up to 12month after last dose vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start18 Jan 2022
- Primary completion13 May 2022
- Study completionJun 2023 (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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Walvax Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313022
- Sponsor's protocol ID
- 202-COV-1003
- Status last verified
- Apr 2023
- First submitted
- 5 Mar 2022
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Immunogenicity and Safety of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy Adults Aged 60 Years and Above
- ClinicalTrials.gov ID
- NCT05313022
- Acronym / sponsor ID
- 202-COV-1003
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shanghai Zerun Biotechnology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Walvax Biotechnology Co., Ltd.
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 13 May 2022 (actual)
- Study completion
- Jun 2023 (estimated)
- First posted
- 6 Apr 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.
The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and immunogenicity of ZR-202-CoV, administered as 2 injections (i.m) at 28 days apart in adult subjects 60 years of age and above.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZR-202-CoV | Experimental | Biological: ZR-202-CoVAdult healthy subjects (60 years of age above, inclusive) receive ZR-202-CoV at Day 0 and Day 28 |
| Placebo | Placebo comparator | Other: PlaceboAdult healthy subjects (60 years of age and above) receive 2 doses of placebo (saline) at Day 0 and Day 28 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Having understood the contents of the clinical study and ICF, and having signed the ICF.
- Adults of both genders, 60 years of age and older.
- Adults who can provide legal proof of identity.
- SARS-COV-2 antibody screening negative at screening visit.
Key exclusion criteria (18 listed)
- Having a clear or suspected allergy to the test vaccine ingredients (including S protein, aluminum hydroxide adjuvant or CpG adjuvant), or have a history of severe allergy to any previous vaccine (such as acute allergic reaction, dyspnea or angioneurotic edema, etc.) (inquiries);
- Having a history of SARS or MERS infection, or a previous infection of COVID-19 (previous nucleic acid or serum antibody test was positive) (inquiries);
- Previous vaccination with SARS-CoV-2 vaccine(including SARS-CoV-2 vaccine for clinical trial) or received other vaccines within 28 days prior to the first dose of vaccine;
- Abnormal skin (such as inflammation, induration, redness and swelling, large area scar, etc.) on both sides of the arm at the vaccination site and affecting the vaccination or safety observation(examination);
- Axillary body temperature ≥37.3℃ before the first dose vaccination(examination);
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 |
|---|---|---|
| ZR-202-CoVAdjuvanted Recombinant SARS-CoV-2 S-protein Subunit Vaccine | Biological | ZR-202-CoV |
| PlaceboNormal saline solution | Other | Placebo |
Primary outcome
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody
Time frame: 28 days after each dose
Proportion of participants achieving seroconversion for SARS-CoV-2 neutralising antibody
Time frame: 28 days after each dose
Geometric mean increase (GMI) of SARS-CoV-2 neutralising antibodies
Time frame: 28 days after each dose
Geometric mean titer (GMT) of SARS-CoV-2 specific IgG binding antibodies.
Time frame: 28 days after each dose
Proportion of participants achieving seroconversion for SARS-CoV-2 specific IgG binding antibodies..
Time frame: 28 days after each dose
Geometric mean increase (GMI) of SARS-CoV-2 specific IgG binding antibodies.
Time frame: 28 days after each dose
5 secondary outcomes
Incidence of adverse events (AEs) after vaccination
Time frame: 28 days after the first or second vaccination
Incidence of solicited adverse events (AEs) after vaccination
Time frame: 30 minutes and 7 days after the first or second vaccination
Incidence of unsolicited adverse events (AEs) after vaccination
Time frame: 28 days after the first or second vaccination
Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis, thyroid and coagulation parameters
Time frame: Day 4 after first or second vaccination
Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
Time frame: up to 12month after last dose vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ZR-202-CoV in people with COVID-19, run by Shanghai Zerun Biotechnology Co.,Ltd 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 18 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 Apr 2023. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibody (time frame: 28 days after each dose). The study lists 6 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 19 Apr 2023.