A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Older Adults.

SARS-CoV-2 Clinical Trial

Official title:

A Phase I, Randomized, Observer-blinded, Placebo-controlled and Dose-escalation Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 60 Years and Over.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05354063
• Other study ID #: SYS6006-002
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2023
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety and preliminary immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese healthy adults aged 60 years and over.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: October 1, 2023
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Age 60 years or older;

2. Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment;

3. Based on the medical history and relevant physical examination and laboratory examination results (normal or abnormal but no clinical significance), the investigator clinically determined that the patient was in good health;

4. Has independent judgment, and participate voluntarily and sign an informed consent form.

Exclusion Criteria:

1. Has a history of SARS-CoV or SARS-CoV-2 infection, or close contact with SARS-CoV-2 infected persons (nucleic acid test positive) or living abroad within 30 days before screening;

2. Positive SARS-CoV-2 antibody test;

3. Previous history of allergy to acetaminophen or vaccination(eg, acute allergic reaction, urticaria, dyspnea, angioneurotic edema, or abdominal pain);

4. Has a history of SARS-CoV-2 vaccination, or have received other inactivated or recombinant vaccines within 7 days, or received live attenuated vaccines within 14 days,before the first dose;

5. Has a medical history or family history of epilepsy, convulsions, neurological diseases and psychiatric diseases;

6. Is contraindicative for intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy;

7. Has known or suspected severe diseases by the judgement of investigators, including but not limited to: respiratory diseases (lung failure, etc.), liver and kidney diseases, cardiovascular diseases (heart failure, severe hypertension, etc.), malignant tumors, infections or allergic skin diseases, HIV infection, or during the acute infection or chronic disease activity period (within 3 days before vaccination).

8. Has chronic diseases which at the discretion of investigator are inappropriate for participation(such as Down 's syndrome, sickle cell anemia or neurological disorders, Guillain-Barre syndrome, etc., not including stable diabetes mellitus/hypertension);

9. Known immunological impairment or dysfunction diagnosed by the hospital before enrollment, or functional asplenia or splenectomy due to any condition;

10. For women of childbearing potential: positive pregnancy test, being in pregnancy or breastfeeding, or have a pregnancy plan within one year;male: their spouse of childbearing age has plans to become pregnant within 1 year;

11. Is participating in other clinical trials or plan to participate in other clinical trials during the study period;

12. Has received immune enhancement or immunosuppressive therapy within 3 months before the first dose of vaccine (continuous oral or instillation for more than 14 days); or received whole blood, plasma and immunoglobulin therapy within one month;

13. Is unlikely to adhere to the study procedures or keep appointments at the discretion of the investigators;or plan to permanently relocate before the end of study; or plan to leave the resident location for a long time at the scheduled visit; or has any other conditions that are inappropriate for participation for this study.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Biological:
• 20 µg dose of SYS6006
20 µg dose of SYS6006 vaccine IM on day 0 and day 21.
• 30 µg dose of SYS6006
30 µg dose of SYS6006 vaccine IM on day 0 and day 21.

Drug:
• Placebo
Placebo IM on day 0 and day 21.

Locations

Country	Name	City	State
China	Shulan(hangzhou) Hospital	Hangzhou	Zhejiang
China	Sir Run Run Hospital Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adverse events, including solicited and unsolicited events		From the first dose through 30 days following the second dose.
Primary	adverse events associated with the study intervention		From the first dose through 30 days following the second dose.
Secondary	Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of anti-SARS-CoV-2 antibody (specific IgG antibody and neutralizing antibody )		14 days after the first dose; 7 days, 14 days, 30 days, 90 days, 180 days and 360 days after the second dose
Secondary	Serious adverse events (SAE)		from the first dose through 12 months after the second dose.
Secondary	Adverse events of special interest (AESI)		from the first dose through 12 months after the second dose.
Secondary	Laboratory test related adverse events		4 days following each dose.