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

NCT05354063 | Unknown Phase 1

• 1 other identifier: SYS6006-002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (2)

• adverse events, including solicited and unsolicited events

  From the first dose through 30 days following the second dose.

• adverse events associated with the study intervention

  From the first dose through 30 days following the second dose.

Secondary Outcomes (4)

• 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

• Serious adverse events (SAE)

  from the first dose through 12 months after the second dose.

• Adverse events of special interest (AESI)

  from the first dose through 12 months after the second dose.

• Laboratory test related adverse events

  4 days following each dose.

Study Arms (3)

Vaccine group 1

EXPERIMENTAL

20μg dose of SYS6006 vaccine IM, on day 0 and day 21.

Biological: 20 μg dose of SYS6006

Vaccine group 2

EXPERIMENTAL

30μg dose of SYS6006 vaccine IM, on day 0 and day 21.

Biological: 30 μg dose of SYS6006

Placebo

PLACEBO COMPARATOR

placebo IM, on day 0 and day 21 .

Drug: Placebo

Interventions

20 μg dose of SYS6006 BIOLOGICAL

20 μg dose of SYS6006 vaccine IM on day 0 and day 21.

Vaccine group 1

30 μg dose of SYS6006 BIOLOGICAL

30 μg dose of SYS6006 vaccine IM on day 0 and day 21.

Vaccine group 2

Placebo DRUG

Placebo IM on day 0 and day 21.

Placebo

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 60 years or older;
• Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment;
• 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;
• Has independent judgment, and participate voluntarily and sign an informed consent form.

You may not qualify if:

• 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;
• Positive SARS-CoV-2 antibody test;
• Previous history of allergy to acetaminophen or vaccination(eg, acute allergic reaction, urticaria, dyspnea, angioneurotic edema, or abdominal pain);
• 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;
• Has a medical history or family history of epilepsy, convulsions, neurological diseases and psychiatric diseases;
• Is contraindicative for intramuscular injection, such as having been diagnosed with thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy;
• 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).
• 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);
• Known immunological impairment or dysfunction diagnosed by the hospital before enrollment, or functional asplenia or splenectomy due to any condition;
• 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;
• Is participating in other clinical trials or plan to participate in other clinical trials during the study period;
• 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;
• 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.

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

Study Sites (2)

Sir Run Run Hospital Nanjing Medical University

Nanjing, Jiangsu, China

Location

Shulan(hangzhou) Hospital

Hangzhou, Zhejiang, China

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: April 29, 2022
• Study Start: June 1, 2022
• Primary Completion: September 5, 2022
• Study Completion: October 1, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)