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Recombinant new coronavirus vaccine (CHO cells) placebo groupWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (5)


Name (Synonyms) Correlation
drug2046 Recombinant new coronavirus vaccine (CHO cells) high-dose group Wiki 1.00
drug2045 Recombinant new coronavirus vaccine (CHO cell) low-dose group Wiki 1.00
drug2987 rhDNase I Wiki 0.71
drug2936 oral nutrition supplement (ONS) enriched in eicosapentaenoic acid, gamma-linolenic acid and antioxidants Wiki 0.71
drug2862 isocaloric/isonutrigenous ONS Wiki 0.71

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (0)


Name (Synonyms) Correlation

There are 2 clinical trials

Clinical Trials


1 A Multi-center, Double-blind, Randomized, Placebo Parallel Controlled, Safety and Tolerability Phase I Clinical Trial of Recombinant Novel Coronavirus Vaccine (CHO Cells) in Healthy People Between 18 and 59 Years of Age

In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose. The researchers conducted a safety evaluation and agreed to follow-up after discharge.

NCT04445194 Coronavirus Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group
MeSH:Coronavirus Infections

Primary Outcomes

Description: The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site, vital signs, blood routine, blood biochemistry, and urine routine.

Measure: The number of adverse events after intramuscular injection

Time: Up to one year after the last vaccination

Secondary Outcomes

Description: All subjects The levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ levels before each vaccination, day 14 after the first vaccination, day 7 after the second vaccination, and 1 and 6 months after the entire vaccination. All subjects before each dose of vaccination, on the 14th day after the first dose, on the 7th day after the second and 1 month and 6 months after the full vaccination That Positive rate of New coronavirus (SARS-CoV-2) neutralizing antibody、S protein binding antibody (IgG) and RBD protein binding antibody (IgG). All subjects before each dose of vaccination, on the 14th day after the first dose, on the 7th day after the second and 1 month and 6 months after the full vaccination That Titer level and its multiplier than before exemption of New coronavirus (SARS-CoV-2) neutralizing antibody、S protein binding antibody (IgG) and RBD protein binding antibody (IgG).

Measure: Immunogenic end point

Time: Within 6 months after the last dose of vaccination

2 A Randomized, Blinded, Placebo-controlled Trial to Evaluate the Immunogenicity and Safety of a Recombinant New Coronavirus Vaccine (CHO Cell) With Different Doses and Different Immunization Procedures in Healthy People Aged 18 to 59 Years

A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.

NCT04466085 Coronavirus Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group
MeSH:Coronavirus Infections

Primary Outcomes

Description: Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination

Measure: Neutralizing antibody positive conversion rate

Time: 30 days after inoculation

Secondary Outcomes

Description: GMT and positive rate of neutralizing antibody 14 days after the first dose of pre-vaccination people

Measure: Neutralizing antibody GMT, positive rate

Time: 14 days after inoculation

Description: GMT, positive conversion rate/positive rate of neutralizing antibodies 14 days after full vaccination in the pre-vaccination population

Measure: Neutralizing antibody GMT, positive conversion rate/positive rate

Time: 14 days after inoculation

Description: Neutralizing antibody GMT 30 days after vaccination in pre-negative people

Measure: Neutralizing antibody GMT

Time: 30 days after inoculation

Description: Neutralizing antibody GMT in the 6th and 12th month after the entire vaccination

Measure: Neutralizing antibody GMT

Time: 6th and 12th month after inoculation

Description: Neutralizing antibody GMI and positive rate at the 6th and 12th month of the entire vaccination

Measure: Neutralizing antibody GMI, positive rate

Time: 6th and 12th month after inoculation

Description: Levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ on the 4th day and 12 months after the entire vaccination

Measure: IL-2, IL-4, IL-5, IL-6 and IFN-γ levels

Time: 4th day and 12 months after inoculation

Description: Adverse events 30 days after the first dose of vaccine to the entire exemption

Measure: Adverse events

Time: 30 days after inoculation

Description: Serious adverse events from day 0 after vaccination to 12 months after the entire immunization

Measure: Serious adverse event

Time: 12 months after inoculation


No related HPO nodes (Using clinical trials)