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Status unknownNCT04636333Updated Mar 31, 2022

Phase I Trial of a Recombinant COVID-19 Vaccine (CHO Cell)

A Phase 1 interventional study of Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 and Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 in COVID-19, sponsored by Jiangsu Province Centers for Disease Control and Prevention. Status unknown at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Jiangsu Province Centers for Disease Control and Prevention · Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. After randomization, the trial for each subject will last for approximately 13 months. Screening period is 1 week prior to randomization (Day -7 to Day -1), and each dose of either SARS-CoV-2 vaccine (CHO Cell) or placebo will be given intramuscularly (IM) on Day 0 and Day 14 for a two-dose regimen, or on Day 0, Day 14, and Day 28 for a three-dose regimen. Subjects who are ≥18 years old and ≤ 59 years old will be enrolled in adult group, and healthy elderly population who are >59 years old will be enrolled in elderly group. After adult group completes the follow-up 7 days after first vaccination, elderly group will be recruited.

Read the detailed description

This is a phase I, randomized, placebo-controlled, double-blind study, to evaluate safety and immunogenicity of a recombinant SARS-CoV-2 vaccine (CHO cell) in Chinese healthy population aged 18 years and older. Healthy adults who are ≥18 years old and ≤59 years old will be enrolled in the adult group and healthy elderly population who are >59 years old will be enrolled in the elderly group. To ensure the enrollment of healthy subjects, screening tests (hematology, biochemistry, and urinalysis) will be performed prior to the vaccination. In the adults group, there are four regimen cohort: middle-dose at 0, 14 schedule, high-dose at 0, 14 schedule, middle-dose at 0,14, 28 schedule and high-dose at 0,14,28 schedule. In the elderly group, there are two regimen cohort: middle-dose at 0,14, 28 schedule and high-dose at 0,14,28 schedule. The subjects in regimen cohort will be randomized to receive vaccines or placebos at a ratio of 2:1.

The study will set up an Independent Data Monitoring Committee (IDMC) to conduct overall supervision. The IDMC is required to review the unblinded data when a significant event or risk occurs in the study that might cause the study to be suspended.

02

Conditions studied

  • COVID-19

Browse trials for

Keywords

  • Safety
  • Tolerability
  • Immunogenicity
  • SARS-CoV-2 Vaccine
  • Recombinant vaccine
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's planned enrollment of 216 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Jiangsu Province Centers for Disease Control and Prevention is the lead sponsor of 77 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • Healthy subjects of ≥ 18 years old.
  • The subject can understand and voluntarily sign the informed consent.
  • The subject can The subject canprovide legal identification.

Exclusion Criteria:

  • Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomatic infection in the previous 14 days, or a travel history/residential history in a community where a case has been reported.
  • Have a history of contact with a person infected with SARS-CoV-2(a person with a positive nucleic acid test) in the previous 14 days.
  • Patients with fever or respiratory symptoms who have been to middle or high-risk areas in the past 14 days or have exit history, or come from communities with case reports.
  • In the past 14 days, there have been 2 or more cases of fever and/or respiratory symptoms in small areas such as homes, offices, school classes, etc.
  • Have a history of SARS.
  • Have a history of SARS-CoV-2 infection.
  • Positive in SARS-CoV-2 IgG or IgM antibody screening.
  • Positive in RT-PCR test of SARS-CoV-2 in throat swab.
  • Positive in HIVantibody screening.
  • Women who are breastfeeding, pregnant, or planning to become pregnant during the study period (based on the subject's self-report and blood pregnancy test results for women of childbearing age), or men who plan to conceive their partners during the study period.
  • Subjects with body mass index (BMI) ≥35 kg/m2.
  • Have a history of asthma, a history of vaccine or vaccine component allergy, have serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema.
  • Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
  • Subjects with autoimmune diseases or immunodeficiency/immunosuppression.
  • Subjects with severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver and kidney diseases, malignant tumors, etc.
  • Subjects with severe neurological disease (epilepsy, convulsions or convulsions) or mental illness.
  • Subjects with thyroid disease or history of thyroidectomy, no spleen, functional asthenia, and any spleen or splenectomy caused by any condition.
  • Abnormal blood coagulation function diagnosed by a doctor (such as coagulation factor deficiency, coagulopathy, abnormal platelet) or obvious bruise or coagulation disorder.
  • Have received immunosuppressant therapy, cytotoxic therapy, and inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis).
  • Physical examination or chest CT imaging reveals clinically significant abnormalities.

  • Abnormal laboratory test results such as hematology and biochemistry that are beyond the reference value range and have clinical significance.

    1. Routine blood test: white blood cell count, hemoglobin, platelet count.
    2. Blood biochemical index detection: alanine aminotransferase (ALT), aspartate aminotransferase (AST), fasting blood glucose, C-reactive protein, total bilirubin (TBIL), creatinine (CR), creatine phosphokinase (CPK).
    3. Urine routine indicators: urine protein (PRO), urine sugar, urine red blood cells.
    4. Coagulation function test: prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB).
  • Have a long history of alcohol or drug abuse.
  • Received blood products within 3 months before receiving trial vaccine.
  • Received other study drugs within 30 days before receiving the trail vaccine.
  • Received a live attenuated vaccine within 14 days before receiving the experimental vaccine.
  • Received a subunit or inactivated vaccine within 7 days before receiving the experimental vaccine.
  • Various acute or chronic diseases occurred in the past 7 days.
  • Axillary body temperature>37.0℃ before vaccination.
  • According to the judgment of the investigator, the subject has any other factors that are not suitable for participating in the clinical trial.

Exclusion criteria of subsequent dose:

If one of the following (1) to (4) adverse events (AE) occurs, the vaccination is prohibited, but other research steps can be continued according to the investigator's judgment; if one of the following (5), (6) adverse events occurs , The investigator will judge whether to inoculate; if one of the following events (7) to (10) occurs, the vaccination can be postponed within the time window specified in the plan.

  • (1)The subjects used the same vaccine other than the experimental vaccine during the study.
  • (2)Any serious adverse reactions that are causally related to vaccination.
  • (3)Severe allergic or hypersensitivity reactions after vaccination (including urticaria/skin rash within 30 minutes after vaccination).
  • (4)Any confirmed or suspected autoimmune disease or immunodeficiency disease, including human immunodeficiency virus (HIV) infection.
  • (5)Acute or new-onset chronic disease after vaccination.
  • (6)Other reactions (including severe pain, severe swelling, severe activity limitation, persistent high fever, severe headache, or other systemic or local reactions) are judged by the investigator.
  • (7)Acute illness at the time of vaccination (Acute illness refers to moderate or severe illness with or without fever).
  • (8)Axillary temperature >37.0℃ before vaccination.
  • (9)Vaccination of subunit vaccine or inactivated vaccine within 7 days, live attenuated vaccine within 14 days.
  • (10)According to the investigator's judgment, the subject has any other factors that are not suitable for vaccination.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
216 participants (estimated)

Study arms

  • Experimental
    Middle-dose vaccine (18-59 years) & Two dose regimen

    Two doses of middle-dose experimental vaccine at the schedule of day 0, 14.

    Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14

  • Experimental
    Middle-dose vaccine (18-59 years) & Three dose regimen

    Three doses of middle-dose experimental vaccine at the schedule of day 0, 14 28.

    Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28

  • Experimental
    High-dose vaccine (18-59 years) & Two dose regimen

    Two doses of high-dose experimental vaccine at the schedule of day 0, 14.

    Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14

  • Experimental
    High-dose vaccine (18-59 years) & Three dose regimen

    Two doses of High-dose vaccine at the schedule of day 0, 14, 28.

    Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28

  • Experimental
    Middle-dose vaccine (> 59 years) & Three dose regimen

    Three doses of middle-dose experimental vaccine at the schedule of day 0, 14, 28.

    Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28

  • Experimental
    High-dose vaccine (> 59 years) & Three dose regimen

    Three doses of high-dose experimental vaccine at the schedule of day 0, 14, 28.

    Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28

  • Placebo comparator
    Middle-dose placebo (18-59 years) & Two dose regimen

    Two doses of middle-dose placebo at the schedule of day 0, 14.

    Biological: Two doses of placebo at the schedule of day 0, 14 #middle-dose group#

  • Placebo comparator
    Middle-dose placebo (18-59 years) & Three dose regimen

    Three doses of middle-dose placebo at the schedule of day 0, 14, 28.

    Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#

  • Placebo comparator
    High-dose placebo (18-59 years) & Two dose regimen

    Two doses of high-dose placebo at the schedule of day 0, 14.

    Biological: Two doses of placebo at the schedule of day 0, 14 #High-dose group#

  • Placebo comparator
    High-dose placebo (18-59 years) & Three dose regimen

    Three doses of high-dose placebo at the schedule of day 0, 14, 28.

    Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#

  • Placebo comparator
    Middle-dose placebo (> 59 years) & Three dose regimen

    Three doses of high-dose placebo at the schedule of day 0, 14, 28.

    Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#

  • Placebo comparator
    High-dose placebo (> 59 years) & Three dose regimen

    Three doses of high-dose placebo at the schedule of day 0, 14, 28.

    Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#

Interventions

06

What researchers measure

Primary outcomes

  1. The proportion of adverse reactions (AR) up to Day 28 after prime and boost vaccination of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.

    Time frame: 28 days after first dose

Secondary outcomes

  1. The proportion of adverse events (AE) within 7 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.

    Time frame: 7 days after each dose

  2. The proportion of abnormal markers of hematology, blood chemistry and urine analysis within 3 days after each dose of the recombinant SARS-CoV-2 vaccine (CHO cell) or placebo

    Time frame: 3 days after each dose

  3. The proportion of serious adverse events up to Month 12 after prime and boost vaccination.

    Time frame: Month 12 after prime and boost vaccination

  4. The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GMI at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#

    Time frame: Day 14, Day 21, Day 28, Day 42 after prime vaccination

  5. The proportion of IgG antibody positive rate at Day 14, Day 21, Day 28, Day 42 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 vaccination program#

    Time frame: Day 14, Day 21, Day 28, Day 42 after prime vaccination

  6. The proportion of neutralizing antibody positive conversion rate, positive rate, GMT and GM at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#

    Time frame: Day 28, Day 35, Day 42, Day 56 after prime vaccination

  7. The proportion of IgG antibody positive rate at Day 28, Day 35, Day 42, Day 56 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo.#Day 0, Day 14 ,Day 28 vaccination program#

    Time frame: Day 28, Day 35, Day 42, Day 56 after prime vaccination

Other outcomes

  1. The proportion of IFN-γ secreted by T cells at Day 14 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo using ELISpot detection method

    Time frame: Day 14 after prime vaccination of recombinant SARS-CoV-2 vaccine (CHO cell) or placebo

  2. Changes in serum cytokine (IL2, IL6) levels from baseline after 3 days of each dose

    The units of IL2 and IL6 are both pg/ml

    Time frame: 3 days of each dose

  3. The proportion of neutralizing antibody and the GMT up to Month 3 after the whole process of vaccination

    Time frame: Month 3 after the whole process of vaccination

  4. The proportion of neutralizing antibody and the GMT up to Month 6 after the whole process of vaccination

    Time frame: Month 6 after the whole process of vaccination

  5. The proportion of neutralizing antibody and the GMT up to Month12 after the whole process of vaccination

    Time frame: Month 12 after the whole process of vaccination

07

Study locations

1 of 1 sites recruiting
  • Jiangsu Provincial Center for Diseases Control and Prevention
    Nanjing, Jiangsu, China
    Recruiting
08

References and documents

Publications

  • Luo D, Pan H, He P, Yang X, Li T, Ning N, Fang X, Yu W, Wei M, Gao H, Wang X, Gu H, Mei M, Li X, Zhang L, Li D, Gao C, Gao J, Fei G, Li Y, Yang Y, Xu Y, Wei W, Sun Y, Zhu F, Hu Z, Wang H. A randomized, double-blind, placebo-controlled phase 1 and phase 2 clinical trial to evaluate efficacy and safety of a SARS-CoV-2 vaccine SCoK in adults. Clin Transl Med. 2022 Sep;12(9):e1016. doi: 10.1002/ctm2.1016. PubMed 36103390 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2020 to primary completion in Dec 2021, 13 months.

Of 138 non-industry phase 1 interventional studies under COVID-19, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 22. This study's 13 months is close to that.

Counting every sponsor, half of 314 studies reached it within 8 months; a quarter within 3 and three quarters within 15.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2020
First posted
Nov 19, 2020
StartActual
Oct 30, 2020
Primary completionActual
Dec 7, 2021
CompletionEst.
Jul 7, 2022
Last update
Mar 31, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04636333
Lead sponsor
Jiangsu Province Centers for Disease Control and Prevention
Collaborators
307 Hospital of PLA, ZHONGYIANKE Biotech Co, Ltd., LIAONINGMAOKANGYUAN Biotech Co, Ltd
Responsible party
Sponsor
First posted
Nov 19, 2020
Start date
Oct 30, 2020
Primary completion
Dec 7, 2021
Completion
Jul 7, 2022 (estimated)
Last update
Mar 31, 2022

Study contacts

Fanyue Meng, Doctor
Contact
mfy19780712@163.com
18915999245
Fengcai Zhu, Doctor
principal investigator · Jiangsu Province Centers for Disease Control and Prevention

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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