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Phase II Clinical Trial of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05373472
Recruitment Status : Recruiting
First Posted : May 13, 2022
Last Update Posted : July 11, 2022
Sponsor:
Information provided by (Responsible Party):
CanSino Biologics Inc.

Brief Summary:
To evaluate the safety and immunogenicity of COVID-19 mRNA vaccine in people aged 18 years and older, 300 participants will be enrolled and divided into two groups: low- and high-dose groups. Each dose group (150 people) will be divided into 2 age groups (75 each):18 to 59 years old and ≥ 60 years old. The subjects will be randomized into vaccine group or placebo group in a ratio of 2:1. Subjects will complete 2 doses of vaccination on Day 0 and Day 21, in which the low-dose group will received 0.3 ml of the study vaccine or placebo, and the high dose group received 0.5 ml of the study vaccine or placebo.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: COVID-19 mRNA vaccine Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Dose-exploring, Placebo-controlled, Multi-center Phase II Clinical Trial Evaluating the Safety and Immunogenicity of COVID-19 mRNA Vaccine in Adults Aged 18 Years and Older
Actual Study Start Date : July 6, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vaccine Group, low dose, 18-59 year-old
2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21
Biological: COVID-19 mRNA vaccine
2 doses of vaccine on Day 0 and Day 21

Experimental: Vaccine Group, low dose, 60 year-old and above
2 doses of COVID-19 mRNA vaccine (30µg, 0.3 ml) on Day 0 and Day 21
Biological: COVID-19 mRNA vaccine
2 doses of vaccine on Day 0 and Day 21

Experimental: Vaccine Group, high dose, 18-59 year-old
2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21
Biological: COVID-19 mRNA vaccine
2 doses of vaccine on Day 0 and Day 21

Experimental: Vaccine Group, high dose, 60 year-old and above
2 doses of COVID-19 mRNA vaccine (50µg, 0.5 ml) on Day 0 and Day 21
Biological: COVID-19 mRNA vaccine
2 doses of vaccine on Day 0 and Day 21

Placebo Comparator: Placebo Group, low dose, 18-59 year-old
2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21
Biological: Placebo
2 doses of placebo on Day 0 and Day 21

Placebo Comparator: Placebo Group, low dose, 60 year-old and above
2 doses of placebo (0µg, 0.3 ml) on Day 0 and Day 21
Biological: Placebo
2 doses of placebo on Day 0 and Day 21

Placebo Comparator: Placebo Group, high dose, 18-59 year-old
2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21
Biological: Placebo
2 doses of placebo on Day 0 and Day 21

Placebo Comparator: Placebo Group, high dose, 60 year-old and above
2 doses of placebo (0µg, 0.5 ml) on Day 0 and Day 21
Biological: Placebo
2 doses of placebo on Day 0 and Day 21




Primary Outcome Measures :
  1. Immunogenicity of wild type neutralizing antibodies [ Time Frame: 28 days after complete immunization ]
    GMT of wild type neutralizing antibodies

  2. Immunogenicity of wild type neutralizing antibodies [ Time Frame: 28 days after complete immunization ]
    Sero-conversation rate of wild type neutralizing antibodies

  3. The incidence of adverse reactions (AR) [ Time Frame: Within 14 days of each vaccination ]
    To evaluate the incidence of adverse reactions (AR) in all subjects


Secondary Outcome Measures :
  1. The incidence of adverse reactions (AR) [ Time Frame: Within 28 days of complete immunization ]
    To evaluate the incidence of adverse reactions (AR) in all subjects

  2. The incidence of adverse reactions (AR) [ Time Frame: Within 60 minutes of each vaccination ]
    To evaluate the incidence of adverse reactions (AR) in all subjects

  3. The incidence of SAE, MAE and AESI [ Time Frame: 12 months after complete vaccination ]
    To evaluation the incidence of SAE, MAE, and AESI in all subjects

  4. Immunogenicity of wild type neutralizing antibodies [ Time Frame: Before the 1st dose, 14 days after the 2nd dose, and 3, 6, 12 months after the 2nd dose ]
    Sero-conversation rate of wild type neutralizing antibodies

  5. Immunogenicity of wild type neutralizing antibodies [ Time Frame: Before the 1st dose, 14 days after the 2nd dose, and 3, 6, 12 months after the 2nd dose ]
    GMT of wild type neutralizing antibodies

  6. Immunogenicity of wild type neutralizing antibodies [ Time Frame: Before the 1st dose, 14 days after the 2nd dose, and 3, 6, 12 months after the 2nd dose ]
    GMI of wild type neutralizing antibodies

  7. Immunogenicity of wild type neutralizing antibodies [ Time Frame: 28 days after complete immunization ]
    GMI of wild type neutralizing antibodies

  8. Immunogenicity of anti-S-RBD Ig G antibodies [ Time Frame: Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination ]
    Sero-conversation rate of anti-S-RBD Ig G antibodies

  9. Immunogenicity of anti-S-RBD Ig G antibodies [ Time Frame: before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination ]
    GMC of anti-S-RBD Ig G antibodies

  10. Immunogenicity of anti-S-RBD Ig G antibodies [ Time Frame: before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination ]
    GMI of anti-S-RBD Ig G antibodies

  11. Cellular immunity [ Time Frame: Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination ]
    The response levels and positive rates of IL-2 produced by S protein RBD by ICS in the first 15 subjects in each group

  12. Cellular immunity [ Time Frame: Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination ]
    The response levels and positive rates of IL-4 produced by S protein RBD by ICS in the first 15 subjects in each group

  13. Cellular immunity [ Time Frame: Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination ]
    The response levels and positive rates of IL-5 produced by S protein RBD by ICS in the first 15 subjects in each group

  14. Cellular immunity [ Time Frame: Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination ]
    The response levels and positive rates of IL-17 produced by S protein RBD by ICS in the first 15 subjects in each group

  15. Cellular immunity [ Time Frame: Before the 1st dose, 14 days after the 2nd dose, 28 days after the 2nd dose and month 3,6,12 months after 2nd vaccination ]
    The response levels and positive rates of IFN-γ produced by S protein RBD by ICS in the first 15 subjects in each group

  16. Changes in laboratory indicators [ Time Frame: Before 1st dose and 28 days after second dose ]
    Changes in white blood cell count

  17. Changes in laboratory indicators [ Time Frame: Before 1st dose and 28 days after second dose ]
    Changes in neutrophils

  18. Changes in laboratory indicators [ Time Frame: Before 1st dose and 28 days after second dose ]
    Changes in lymphocyte count

  19. Changes in laboratory indicators [ Time Frame: Before 1st dose and 28 days after second dose ]
    Changes in platelet count

  20. VOC/VOI serum cross neutralization [ Time Frame: 28 days after complete immunization ]
    To evaluated the level of VOC/VOI serum cross neutralization results in all subjects.



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:

  1. Adults aged 18 years and above with BMI not lower than 18 ;
  2. Volunteers are able and willing to comply with the requirements of the clinical trial protocol, and volunteers or witnesses can sign informed consent forms;
  3. Willing to discuss the medical history with the investigator or doctor and allow access to all medical records related to this trial;
  4. Provide 48-hour PCR negative report;
  5. Have not received any other COVID-19 vaccines.

Exclusion Criteria:

  • Criteria for exclusion of the first dose

    1. Other medical or psychiatric conditions, including recent (within the past year) or current presence of suicidal ideation/behavior, or laboratory abnormalities that may increase the risk of participating in the study, or subjects who are not suitable to participate in the study according to the investigator's judgment;
    2. Positive for human immunodeficiency virus (HIV);
    3. History of infection or disease history of Middle East Respiratory Syndrome (MERS), SARS or other coronaviruses or related immunizations;
    4. History of serious adverse reactions associated with the vaccine and/or a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine under study;
    5. Immunocompromised patients with known or suspected immunodeficiency identified by medical history and/or physical examination;
    6. Bleeding constitution or condition associated with prolonged bleeding which investigators believe that intramuscular injection is contraindicated;
    7. Women who test positive for blood pregnancy or are breastfeeding, volunteers or their partners have a pregnancy plan within 12 months;
    8. Severe hypertension and uncontrollable medication (on-site measurement: systolic blood pressure ≥ 160mmHg, diastolic blood pressure ≥ 100mmHg);
    9. Have a serious chronic disease or the condition is in the progression period can not be smoothly controlled, such as diabetes, thyroid disease, etc.;
    10. History of severe myocarditis, pericarditis and other heart diseases;
    11. Plans to receive other vaccines within 28 days before and after receiving the test vaccine;
    12. Those receiving immunosuppressive therapy, including cytotoxic drugs or systemic corticosteroids, such as for cancer or autoimmune diseases, or who were scheduled to receive treatment throughout the study period. If systemic corticosteroids are used in a short period of time (< 14 days) for the treatment of acute illness, subjects should not enter this study until at least 28 days after corticosteroid therapy has been discontinued prior to study vaccination. Inhalation/spraying, intra-articular, intraskeletal, or topical (skin or eyes) use of corticosteroids is permitted;
    13. Receiving blood/plasma products or immunoglobulins 60 days prior to study vaccination or plan to receive for the entire study duration;
    14. Engage in other interventional studies within 28 days prior to entering the study and/or during the study's participation;
    15. Participated in other interventional studies of lipid-containing nanoparticles;
    16. Have symptoms of COVID-19 such as respiratory symptoms, fever, cough, shortness of breath, and dyspnea;
    17. Fever, axillary temperature > 37.0 °C.

Second dose exclusion criteria:

  1. Severe allergic reactions occur after the first vaccination;
  2. Serious adverse reactions with causal relationship during the first vaccination;
  3. Those who are newly discovered or newly occurring after the first vaccination do not meet the inclusion criteria of the first dose or meet the exclusion criteria of the first dose, and the investigator shall decide whether to continue to participate in the study;
  4. Other reasons for exclusion that the investigators believe.

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): NCT05373472


Contacts
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Contact: YING WANG 022-58213600-6051 ying.wang@cansinotech.com

Locations
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China, Beijing
Beijing Friendship Hospital Recruiting
Beijing, Beijing, China
Contact: Ruihua Dong, PhD         
China, Hebei
Hebei Petro China Center Hospital Recruiting
Langfang, Hebei, China
Contact: Kexin Zhao, MD         
China, Hunan
Hunan Provincial Center for Disease Control and Prevention Recruiting
Changsha, Hunan, China
Contact: Tao Huang, Bachelor         
Sponsors and Collaborators
CanSino Biologics Inc.
Investigators
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Principal Investigator: Ruihua Dong Beijing Friendship Hospital
Principal Investigator: Kexin Zhao Hebei Petro China Center Hospital
Principal Investigator: Tao Huang Hunan Provincial Center for Disease Control and Prevention
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Responsible Party: CanSino Biologics Inc.
ClinicalTrials.gov Identifier: NCT05373472    
Other Study ID Numbers: CTP-NCVM-002
First Posted: May 13, 2022    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: May 2022

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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 CanSino Biologics Inc.:
COVID
mRNA
Vaccine
Placebo
Safety
Immunogenicity
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases