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COVID-19Phase 1NCT04982068

Phase I Clinical Trial of Recombinant SARS-CoV-2 Spike Protein Vaccine (CHO Cell) for the Prevention of COVID-19

A Phase 1 study testing 202-CoV low adjuvant dose, 202-CoV low antigen dose and 202-CoV standard dose in people with COVID-19, run by Shanghai Zerun Biotechnology Co.,Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and preliminary immunogenicity of 202-CoV at multiple dose levels, administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age and above. 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?
202-CoV low adjuvant dose, 202-CoV low antigen dose and 202-CoV standard dose
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteChina
Study dates
12 Jul 2021to Jun 2023
Phase
Phase 1
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

  • Healthy individuals aged 18-59 years as well as 60 years and above who can provide legal identification (males and females are both required).
  • Willing to participate in the study with informed consent prior to screening
  • Negative in SARS-CoV-2 IgG and IgM test at screening.
  • Women of childbearing potential must be using effective method of birth control for 14 days prior to the enrollment of the study vaccine/placebo and must agree to continue such precautions during the study until 30 days after the second dose of the study vaccine/placebo.
  • Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 30 days after the second dose of the study vaccine/placebo.

Who cannot join

  • Confirmed or asymptomatic COVID-19 cases or SARS-CoV-2 infection(had positive in SARS-CoV-2 nucleic acid test or serological test).
  • Had a history of traveling or residence in domestic area of high and moderate pandemic risk, overseas or epidemic areas, or had a history of contact with confirmed, asymptomatic or suspected COVID-19 cases within the past 14 days;
  • History of SARS;
  • Received SARS-CoV-2 vaccines for emergency use or approved SARS-CoV-2 vaccines;
  • Individuals involving a clinical study within 6 months prior to the screening visit; or planning to participate in another clinical study during study period.
  • Clinical laboratory abnormalities and with clinical significance judged by investigator
Show all 18Show fewer
  • Individual's systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 100mmHg at screening visit
  • Axillary temperature >=37.3℃ prior to vaccination
  • Individuals in other acute diseases, or in the acute phase of chronic diseases within 3 days prior to the signing of the informed consent form.
  • Received immunoglobulin and/or blood product 3 months prior to the first vaccination.
  • Presence of uncontrolled chronic pulmonary, cardiovascular, renal, hepatic, neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which would include the potential subject in a high-risk category for SARS-CoV-2 infection and/or its complications as judged by the investigator..
  • Individuals with a history of severe allergic reaction (throat swelling, difficult in breath, dyspnea, or shock).
  • Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction [e.g., anaphylaxis to any component of the study vaccines (S protein, Aluminum hydroxide, CpG adjuvant).
  • Any autoimmune or immunodeficiency disease/condition [e.g. human immunodeficiency virus (HIV) infection, Systemic lupus erythematosus (SLE)]
  • Received immunoglobulin, blood-derived products within 3 months prior to the first study vaccination.
  • Abnormal coagulation function (such as coagulation factor deficiency, coagulation disease, platelet abnormality) obvious bruises or coagulopathy.
  • Pregnant women or breastfeeding women.
  • According to the judgment of the investigator, subject has or had any other symptoms, medical history and other factors that are not suitable for participating in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xiangcheng Center for Disease Control and Prevention

    Xuchang

Other trials in China

About this study

Official title: A Randomized, Double-blinded, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Immunogenicity of the Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy Adults Aged 18 Years and Above

The purpose of this double-blind, randomized, controlled study is to assess safety, reactogenicity, and preliminary immunogenicity of 202-CoV at multiple dose levels, administered as 2 injections (i.m) at 28 days apart in adult subjects 18 years of age and above.

Conditions
COVID-19
Being tested
202-CoV low adjuvant dose, 202-CoV low antigen dose, 202-CoV standard dose, 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.

  • 202-CoV low adjuvant doseBiological

    standard dose of 202-CoV with low dose CpG / alum adjuvant

  • 202-CoV low antigen doseBiological

    low dose 202-CoV with CpG / alum adjuvant

  • 202-CoV standard doseBiological

    standard dose 202-CoV with CpG / alum adjuvant

  • PlaceboOther

    Normal saline solution

Study groups in NCT04982068
Study groupRoleWhat they receive
Adult Group 1aExperimentalAdult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low adjuvant dose at Day 0 and Day 28
Receives: Biological: 202-CoV low adjuvant dose
Adult Group 1bExperimentalAdult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV low antigen dose at Day 0 and Day 28
Receives: Biological: 202-CoV low antigen dose
Adult Group 1cExperimentalAdult healthy subjects (18 to 59 years of age, inclusive) receive 202-CoV standard dose at Day 0 and Day 28
Receives: Biological: 202-CoV standard dose
Adult PlaceboPlacebo comparatorAdult healthy subjects (18 to 59 years of age, inclusive) receive 2 doses of placebo (saline) at Day 0 and Day 28
Receives: Other: Placebo
Elderly Group 1dExperimentalAdult healthy subjects (60 years of age and above) receive 202-CoV low adjuvant dose at Day 0 and Day 28
Receives: Biological: 202-CoV low adjuvant dose
Elderly Group 1eExperimentalAdult healthy subjects (60 years of age and above) receive 202-CoV low antigen dose at Day 0 and Day 28
Receives: Biological: 202-CoV low antigen dose
Elderly Group 1fExperimentalAdult healthy subjects (60 years of age and above) receive 202-CoV standard dose at Day 0 and Day 28
Receives: Biological: 202-CoV standard dose
Elderly PlaceboPlacebo comparatorAdult 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.

  1. Incidence of solicited adverse events (AEs) after vaccination

    Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 28) by intensity, relevance.

    Measured: 7 days after the first or second vaccination

  2. Incidence of unsolicited AEs after vaccination

    Percentage of participants with unsolicited AEs for 28 days following each vaccination

    Measured: Frame: Day 0 to Day 56

Secondary outcomes (6)

  1. Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)

    Percentage of participants with SAEs or AESI for 12month after last dose vaccination

    Measured: Day 0 to Month 13

  2. Proportion of subjects with abnormal markers of hematology, biochemistry, urinalysis and coagulation parameters

    Safety Laboratory Values (Serum Chemistry, Hematology)

    Measured: Day 4 after first or second vaccination

  3. Geometric mean titer (GMT) of SARS-CoV-2 neutralising antibodies

    Neutralizing antibody activity as detected by neutralization assay expressed as GMTs at multiple time points through Day 56

    Measured: Day0, Day28, Day42 and Day56

  4. Seroconversion rate (SCR) of SARS-CoV-2 neutralising antibodies

    Neutralizing antibody activity as detected by neutralization assay expressed as seroconversion rate at multiple time points through Day 56

    Measured: Day0, Day28, Day42 and Day56

  5. Geometric mean titer (GMT) of Serum IgG Antibody Levels

    Serum IgG antibody levels specific for the SARS-CoV-2 S protein antigen as detected by ELISA expressed as GMTs at multiple time points through Day 56

    Measured: Day0, Day28, Day42 and Day56

  6. Seroconversion rate (SCR) of Serum IgG Antibody Levels

    Serum IgG antibody levels specific for the SARS-CoV-2 S protein antigen as detected by ELISA expressed as seroconversion rate at multiple time points through Day 56

    Measured: Day0, Day28, Day42 and Day56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2021
  2. Study start12 Jul 2021
  3. Primary completion31 Oct 2021
  4. Study completionJun 2023 (estimated)

Resources

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04982068
Sponsor's protocol ID
202-COV-1001
Status last verified
Apr 2023
First submitted
26 Jul 2021
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liu H, Zhou C, An J, Song Y, Yu P, Li J, Gu C, Hu D, Jiang Y, Zhang L, Huang C, Zhang C, Yang Y, Zhu Q, Wang D, Liu Y, Miao C, Cao X, Ding L, Zhu Y, Zhu H, Bao L, Zhou L, Yan H, Fan J, Xu J, Hu Z, Xie Y, Liu J, Liu G. Development of recombinant COVID-19 vaccine based on CHO-produced, prefusion spike trimer and alum/CpG adjuvants. Vaccine. 2021 Nov 26;39(48):7001-7011. doi: 10.1016/j.vaccine.2021.10.066. Epub 2021 Oct 30.

    PubMed 34750014

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 202-CoV low adjuvant dose, 202-CoV low antigen dose and 202-CoV standard dose 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 5 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 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.

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?

Incidence of solicited adverse events (AEs) after vaccination (time frame: 7 days after the first or second vaccination). 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?

On the ClinicalTrials.gov record for NCT04982068, 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 Apr 2023.

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