COVID-19 Pneumonia
Conditions
Keywords
COVID-19
Brief summary
phase I study will evaluate the safety and tolerability of GEN2-Recombinant COVID-19 Vaccine (CHO cells) in healthy people aged 18 years and older. A total of 234 subjects were enrolled, of which 126 were enrolled in the 18-59-year-old group, and were randomly assigned to receive experimental vaccine 1, experimental vaccine 2, experimental vaccine 3 and placebo in a ratio of 2:2:2:1; 60- A total of 54 people were enrolled in the 69-year-old and ≥70-year-old groups, and were randomly assigned to receive the experimental vaccine 1 and placebo according to the ratio of 2:1.
Interventions
BIOLOGICALExperimental Vaccine 1
Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells，NVSI-06-08) in the deltoid muscle of the upper arm
BIOLOGICALExperimental Vaccine 2
Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells，NVSI-06-08) in the deltoid muscle of the upper arm
BIOLOGICALExperimental Vaccine 3
Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cells，NVSI-06-08) in the deltoid muscle of the upper arm
BIOLOGICALplacebo
Intramuscular injection of low-dose Recombinant placebo in the deltoid muscle of the upper arm
Sponsors
Lanzhou Institute of Biological Products Co., Ltd
Beijing Institute of Biological Products Co Ltd.
National Vaccine and Serum Institute, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age range: healthy people aged 18 and above, who can provide legal identification; * No history of t SARS-CoV-2 vaccination; * Able to provide a negative nucleic acid test certificate for the new coronavirus within 48 hours; * Have the ability to understand (if illiterate, a fair witness is required to accompany the informed consent) research procedures, have informed consent, voluntarily sign the informed consent form, and be able to comply with the requirements of the clinical research protocol； * Inquire about medical history and physical examination, and the investigator judges that the health status is good; * Females of childbearing age (menarche to menopause) were not pregnant (negative urine pregnancy test) at enrollment, were not breastfeeding, and had no reproductive plans within the first 6 months after enrollment and took effective contraceptive measures; 2 weeks prior to enrollment have taken effective contraceptive measures; * Able and willing to complete the entire prescribed study plan throughout the study follow-up period.
Exclusion criteria
First-dose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralizing antibody level against SARS-CoV-2 Positive conversion rate | Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization |
| Neutralizing antibody level against SARS-CoV-2 IgG antibody GMC | Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization |
| Neutralizing antibody level against SARS-CoV-2 positive rate | Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization |
| The incidence rate of any adverse reactions/events | within 30 minutes after vaccination |
| The incidence severity of any adverse reactions/events | within 30 minutes after vaccination |
| the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine | on the 4th day after each dose of vaccination |
| The incidence rate of solicited adverse reactions/events | within 0-7 days after vaccination |
| The incidence severity of solicited adverse reactions/events | within 0-7 days after vaccination |
| Incidence of adverse events leading to withdrawal | within 8-30 days after vaccination |
| Severity of adverse events leading to withdrawal | within 8-30 days after vaccination |
| The incidence of SAE observed | up to 12 months after full course of immunization |
| The incidence of AESI observed | up to 12 months after full course of immunization |
| Neutralizing antibody level against SARS-CoV-2 GMT | Day 15th, 30th, 90th, 180th, 270th, 360th after full course of immunization |
Secondary
| Measure | Time frame |
|---|---|
| Cellular immune response level of subjects aged 18-59 | Before the first vaccination ， 15 days after the full course of immunization |
| GMT of GEN2-Recombinant COVID-19 Vaccine (CHO cells, NVSI-06-08) against VOC in healthy people aged 18 and above | after the full course of immunization |
Countries
China
Outcome results
None listed