Covid 19 Research using Clinical Trials (Home Page)
Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day scheduleWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1058 | High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 1.00 |
| drug1850 | Placebo on a 0- and 28-day schedule Wiki | 1.00 |
| drug1458 | Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Wiki | 1.00 |
| drug1849 | Placebo on a 0- and 14-day schedule Wiki | 0.71 |
| drug1380 | Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.71 |
| drug453 | COVID-19 Antigen/Antibody Rapid Testing, mobile device image capture and telemedicine support Wiki | 0.71 |
| drug1457 | Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.71 |
| drug1057 | High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Wiki | 0.71 |
| drug2407 | T3 solution for injection Wiki | 0.71 |
| drug2457 | Telemedicine Wiki | 0.41 |
| drug1822 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003141 | Communicable Diseases NIH | 0.12 |
| D007239 | Infection NIH | 0.08 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 2 clinical trials
Clinical Trials
1 A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years
This study is a randomized, double-blinded, and placebo-controlled phase Ia/IIa clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged 18~59 Years.
NCT04412538 COVID-19 Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule Biological: Placebo on a 0- and 28-day schedule Biological: Placebo on a 0- and 14-day schedule
Primary Outcomes
Description: Occurence of adverse reactions/events after vaccination
Measure: Adverse reactions/events rate Time: 7 days after vaccinationDescription: Occurence of adverse reactions/events after vaccination
Measure: Adverse reactions/events rate Time: 28 days after vaccinationDescription: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
Measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule) Time: 14 days after the second vaccinationDescription: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
Measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule) Time: 28 days after the second vaccinationDescription: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule) Time: 14 days after the second vaccinationDescription: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule) Time: 28 days after the second vaccinationSecondary Outcomes
Description: Occurence of Serious adverse events after vaccination
Measure: Serious adverse events Time: 12 months after the second vaccinationDescription: Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
Measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule) Time: 7, 14 and 28 days after the second vaccinationDescription: Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
Measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule) Time: 14 and 28 days after the second vaccinationDescription: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
Measure: Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule) Time: 7, 14 and 28 days after the second vaccinationDescription: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Measure: Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule) Time: 14 and 28 days after the second vaccinationDescription: Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
Measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule) Time: 7 and 28 days after the second vaccinationDescription: Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
Measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule) Time: 28 days after the second vaccinationDescription: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
Measure: Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule) Time: 7 and 28 days after the second vaccinationDescription: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Measure: Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule) Time: 28 days after the second vaccinationDescription: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
Measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule) Time: 14 days after the second vaccinationDescription: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
Measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule) Time: 14 days after the second vaccinationDescription: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
Measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule) Time: 28 days after the second vaccinationDescription: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
Measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule) Time: 28 days after the second vaccinationOther Outcomes
Description: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
Measure: Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule) Time: 7, 14 and 28 days after the second vaccinationDescription: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
Measure: Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule) Time: 14 and 28 days after the second vaccinationDescription: Level of anti-N protein antibodies for the Phase Ia immunization schedule of day 0,14
Measure: Level of anti-N protein antibodies Phase Ia (Day 0, 14 schedule) Time: 7, 14 and 28 days after the second vaccinationDescription: Level of anti-N protein antibodies for the Phase IIa immunization schedule of day 0,14
Measure: Level of anti-N protein antibodies Phase IIa (Day 0, 14 schedule) Time: 14 and 28 days after the second vaccinationDescription: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
Measure: Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule) Time: 7 and 28 days after the second vaccinationDescription: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
Measure: Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule) Time: 28 days after the second vaccinationDescription: Level of anti-N protein antibodies for the Phase Ia immunization schedule of day 0,28
Measure: Level of anti-N protein antibodies Phase Ia (Day 0, 28 schedule) Time: 7 and 28 days after the second vaccinationDescription: Level of anti-N protein antibodies for the Phase IIa immunization schedule of day 0,28
Measure: Level of anti-N protein antibodies Phase IIa (Day 0, 28 schedule) Time: 28 days after the second vaccinationDescription: Level of neutralizing antibodies against SARS-CoV-2 in serum for both the Phase Ia immunization schedules
Measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (both schedules) Time: 3, 6, 9 and 12 months after the second vaccinationDescription: Level of neutralizing antibodies against SARS-CoV-2 in serum for both the Phase IIa immunization schedules
Measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (both schedules) Time: 6 and 12 months after the second vaccinationDescription: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for both the Phase Ia immunization schedules
Measure: Level of IgG antibodies against SARS-CoV-2 Phase Ia (both schedules) Time: 3, 6, 9 and 12 months after the second vaccinationDescription: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for both the Phase IIa immunization schedules
Measure: Level of IgG antibodies against SARS-CoV-2 Phase IIa (both schedules) Time: 6 and 12 months after the second vaccinationDescription: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase Ia immunization schedule of day 0,14
Measure: Cellular immune responses Phase Ia (Day 0, 14 schedule) Time: 7, 14 and 28 days after the second vaccinationDescription: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase IIa immunization schedule of day 0,14
Measure: Cellular immune responses Phase IIa (Day 0, 14 schedule) Time: 14 and 28 days after the second vaccinationDescription: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase Ia immunization schedule of day 0,28
Measure: Cellular immune responses Phase Ia (Day 0, 28 schedule) Time: 7 and 28 days after the second vaccinationDescription: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase IIa immunization schedule of day 0,28
Measure: Cellular immune responses Phase IIa (Day 0, 28 schedule) Time: 28 days after the second vaccination2 A Randomized, Double-blind, Placebo-controlled, Phase Ib/IIb Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged ⩾60 Years
This study is a randomized, double-blinded, and placebo-controlled phase Ib/IIb clinical trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the vaccine in healthy people aged ⩾60 Years.
NCT04470609 COVID-19 Biological: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Biological: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Biological: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule Biological: Placebo on a 0- and 28-day schedule
Primary Outcomes
Description: Occurence of adverse reactions/events after vaccination
Measure: Adverse reactions/events rate Time: 7 days after vaccinationDescription: Occurence of adverse reactions/events after vaccination
Measure: Adverse reactions/events rate Time: 28 days after vaccinationDescription: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28
Measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIb Time: 28 days after vaccinationDescription: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
Measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIb Time: 28 days after vaccinationSecondary Outcomes
Description: Occurence of Serious adverse events after vaccination
Measure: Serious adverse events Time: 12 months after the second vaccinationDescription: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28
Measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ib Time: 28 days after the second vaccinationDescription: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28
Measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ib Time: 28 days after the second vaccinationDescription: Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28
Measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase Ib Time: 7 and 28 days after the second vaccinationDescription: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28
Measure: Level of IgG antibodies against SARS-CoV-2 Phase Ib Time: 7 and 28 days after the second vaccinationDescription: Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28
Measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase IIb Time: 28 days after the second vaccinationDescription: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
Measure: Level of IgG antibodies against SARS-CoV-2 Phase IIb Time: 28 days after the second vaccinationOther Outcomes
Description: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28
Measure: Level of IgM antibodies against SARS-CoV-2 Phase Ib Time: 7 and 28 days after the second vaccinationDescription: Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase Ib with vaccination schedule of day 0, 28
Measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase Ib Time: 3, 6, 9 and 12 months after the second vaccinationDescription: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase Ib with vaccination schedule of day 0, 28
Measure: Level of IgG antibodies against SARS-CoV-2 Phase Ib Time: 3, 6, 9 and 12 months after the second vaccinationDescription: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for Phase Ib with vaccination schedule of day 0, 28
Measure: Cellular immune responses Phase Ib Time: 7 and 28 days after the second vaccinationDescription: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
Measure: Level of IgM antibodies against SARS-CoV-2 Phase IIb Time: 28 days after the second vaccinationDescription: Level of anti-N protein antibodies for Phase IIb with vaccination schedule of day 0, 28
Measure: Level of anti-N protein antibodies Phase IIb Time: 28 days after the second vaccinationDescription: Level of neutralizing antibodies against SARS-CoV-2 in serum for Phase IIb with vaccination schedule of day 0, 28
Measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase IIb Time: 6 and 12 months after the second vaccinationDescription: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for Phase IIb with vaccination schedule of day 0, 28
Measure: Level of IgG antibodies against SARS-CoV-2 Phase IIb Time: 6 and 12 months after the second vaccinationDescription: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for Phase IIb with vaccination schedule of day 0, 28
Measure: Cellular immune responses Phase IIb Time: 28 days after the second vaccination