A Study of COVID-19 mRNA Vaccine (SYS6006) in Chinese Healthy Older Adults.
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|ClinicalTrials.gov Identifier: NCT05354063|
Recruitment Status : Recruiting
First Posted : April 29, 2022
Last Update Posted : June 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: 20 μg dose of SYS6006 Biological: 30 μg dose of SYS6006 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I, Randomized, Observer-blinded, Placebo-controlled and Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Immunogenicity of COVID-19 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 60 Years and Over.|
|Estimated Study Start Date :||June 26, 2022|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||October 1, 2023|
Experimental: 20 μg dose of SYS6006
20μg dose of SYS6006 vaccine IM, on day 0 and day 21.
Biological: 20 μg dose of SYS6006
20 μg dose of SYS6006 vaccine IM on day 0 and day 21.
Experimental: 30 μg dose of SYS6006
30 μg dose of SYS6006 vaccine IM, on day 0 and day 21.
Biological: 30 μg dose of SYS6006
30 μg dose of SYS6006 vaccine IM on day 0 and day 21.
Placebo Comparator: Placebo
placebo IM, on day 0 and day 21 .
Placebo IM on day 0 and day 21.
- adverse events [ Time Frame: From the first dose through 30 days following the second dose. ]
- adverse events associated with the study intervention [ Time Frame: From the first dose through 30 days following the second dose. ]
- Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of anti-SARS-CoV-2 antibody (specific IgG antibody and neutralizing antibody ) [ Time Frame: 14 days after the first dose; 7 days, 14 days, 30 days, 90 days, 180 days and 360 days after the second dose ]
- Serious adverse events (SAE) [ Time Frame: from the first dose through 12 months after the second dose. ]
- Adverse events of special interest (AESI) [ Time Frame: from the first dose through 12 months after the second dose. ]
- Laboratory test related adverse events [ Time Frame: 4 days following each dose. ]
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): NCT05354063
|Contact: Yuanzheng Qiu||+86 email@example.com|
|Sir Run Run Hospital Nanjing Medical University||Recruiting|
|Nanjing, Jiangsu, China|
|Contact: Xiang Lu 025 87115857 firstname.lastname@example.org|
|Hangzhou, Zhejiang, China|
|Contact: Guiling Chen +86 571 56097873 email@example.com|
|Principal Investigator:||Lanjuan Li||Shulan (Hangzhou) Hospital|
|Principal Investigator:||Guiling Chen||Shulan (Hangzhou) Hospital|
|Principal Investigator:||Xiang Lu||Sir Run Run Hosipital Nanjing Medical University|
|Principal Investigator:||Yuwen Su||Sir Run Run Hosipital Nanjing Medical University|