Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2 Phase I Clinical Trial (≥60 Years Old)
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant New Coronavirus Vaccines (CHO Cells) in Healthy People Aged 60 Years and Above
1 other identifier
interventional
50
1 country
1
Brief Summary
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells). Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted. Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women. Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 16, 2020
CompletedStudy Start
First participant enrolled
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 18, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJanuary 27, 2021
August 1, 2020
4 months
August 16, 2020
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The number of adverse events after intramuscular injection
The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site.
12 months after full vaccination
Immunogenic end point
The positive rate of neutralizing antibody, S protein binding antibody (IgG), RBD protein binding antibody (IgG) of all subjects before the first dose, 1 month and 6 months after the full vaccination And titer levels and their fold increase before immunity.
Within 6 months after the last dose of vaccination
Study Arms (3)
Population I
EXPERIMENTALPopulation I has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population I is intramuscular injection of deltoid muscle of upper arm with low dose of vaccine.
Population II
EXPERIMENTALPopulation II has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population II is a high-dose vaccine intramuscular injection of deltoid muscle of the upper arm.
Population Ⅲ
PLACEBO COMPARATORPopulation Ⅲ has 10 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅲ is a placebo intramuscular injection of deltoid muscle of the upper arm.
Interventions
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Eligibility Criteria
You may not qualify if:
- The results of physical examination and laboratory examination before screening are abnormal and clinically significant as judged by clinicians, or systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg before screening;
- A history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, blood vessels Neuroedema, etc.; or any previous history of serious side effects after the use of any vaccine or drug;
- People with a history of SARS and SARS-CoV-2 (meet any of the following: ①Have a history of SARS and SARS-CoV-2 infection or onset; ②During this SRAS-CoV-2 epidemic, there are patients who have been diagnosed with the new crown/ Suspected patient contact history);
- Have taken antipyretic or analgesic within 24 hours before the first dose of vaccination;
- Inoculate subunit vaccine and/or inactivated vaccine within 14 days before the first dose of vaccine, and inoculate live attenuated vaccine within 30 days;
- People suffering from the following diseases:
- Acute (within 72 hours) feverish illness;
- Suffering from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;
- Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
- Congenital or acquired immunodeficiency or autoimmune disease history or receiving immunomodulator treatment within 6 months, such as hormones; or monoclonal antibodies; or thymosin; or interferon, etc.; but local medication (such as ointment, Eye drops, inhalation or nasal spray);
- Known to have been diagnosed with infectious diseases, such as: tuberculosis, viral hepatitis and/or human immunodeficiency virus HIV antibody positive or syphilis specific antibody positive;
- Neurological diseases or neurodevelopmental dysfunction (for example, migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis; History of mental illness or family history;
- ⑦Functional asplenia, as well as any cause of aspleen or splenectomy;
- ⑧Severe chronic diseases or conditions that cannot be controlled smoothly in the advanced stage, such as diabetes and thyroid disease;
- ⑨Severe liver and kidney diseases; respiratory diseases that currently require daily drug treatment (for example, chronic obstructive pulmonary disease \[COPD\], asthma) or any treatment for exacerbation of respiratory diseases (for example, asthma exacerbation) in the last 5 years; suffering from severe History of cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or myocarditis or pericarditis;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hunan Provincial Center for Disease Control and Prevention
Xiangtan, Changsha, 411228, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 16, 2020
First Posted
September 16, 2020
Study Start
August 19, 2020
Primary Completion
December 18, 2020
Study Completion
December 31, 2021
Last Updated
January 27, 2021
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share