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

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ClinicalTrials.gov Identifier: NCT04636333
Recruitment Status : Recruiting
First Posted : November 19, 2020
Last Update Posted : January 8, 2021
Sponsor:
Collaborators:
Academy of Military Medical Sciences,Academy of Military Sciences,PLA
ZHONGYIANKE Biotech Co, Ltd.
LIAONINGMAOKANGYUAN Biotech Co, Ltd
Information provided by (Responsible Party):
Jiangsu Province Centers for Disease Control and Prevention

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Biological: Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Biological: Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14 Biological: Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28 Biological: Two doses of placebo at the schedule of day 0, 14 #middle-dose group# Biological: Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group# Biological: Two doses of placebo at the schedule of day 0, 14 #High-dose group# Biological: Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group# Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Recombinant COVID-19 Vaccine (CHO Cell) in Healthy Population Aged 18 Years and Older: A Phase I Study
Actual Study Start Date : October 30, 2020
Estimated Primary Completion Date : April 7, 2021
Estimated Study Completion Date : January 7, 2022

Arm Intervention/treatment
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
Two doses of middle-dose (20µg/0.5ml) 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
Three doses of middle-dose (20µg/0.5ml) 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
Two doses of high-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHOCell) 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
Three doses of middle-dose (40µg/0.5ml) 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
Three doses of middle-dose (20µg/0.5ml) 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
Three doses of middle-dose (40µg/0.5ml) 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#
Two doses of placebo (0.5ml) at the schedule of day 0, 14.

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#
Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.

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#
Two doses of placebo (0.5ml) at the schedule of day 0, 14.

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#
Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.

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#
Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.

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#
Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 [ Time Frame: 3 days of each dose ]
    The units of IL2 and IL6 are both pg/ml

  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04636333


Contacts
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Contact: Fanyue Meng, Doctor 18915999245 mfy19780712@163.com

Locations
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China, Jiangsu
Jiangsu Provincial Center for Diseases Control and Prevention Recruiting
Nanjing, Jiangsu, China
Contact: Mingwei Wei    15950529760    wnmcwmw@163.com   
Sponsors and Collaborators
Jiangsu Province Centers for Disease Control and Prevention
Academy of Military Medical Sciences,Academy of Military Sciences,PLA
ZHONGYIANKE Biotech Co, Ltd.
LIAONINGMAOKANGYUAN Biotech Co, Ltd
Investigators
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Principal Investigator: Fengcai Zhu, Doctor Jiangsu Provincial Center for Disease Control and Prevention
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Responsible Party: Jiangsu Province Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT04636333    
Other Study ID Numbers: JSVCT096
First Posted: November 19, 2020    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu Province Centers for Disease Control and Prevention:
Safety
Tolerability
Immunogenicity
SARS-CoV-2 Vaccine
Recombinant vaccine
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs