A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Participants Aged 18 Years or More

NCT05439824 | Unknown Phase 2 DMC

• 1 other identifier: SYS6006-003
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief Summary

This is a phase 2, randomized, observer-blinded, placebo-controlled clinical study to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (SYS6006）in healthy participants aged 18 or more.

Conditions

SARS-CoV-2 Infection

Outcome Measures

Primary Outcomes (3)

• Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody

  14 days after the second dose

• Adverse events (AEs), including solicited AEs and unsolicited AEs

  From the first dose through 30 days following the second dose

• AEs associated with the study intervention

  From the first dose through 30 days following the second dose

Secondary Outcomes (5)

• Serious adverse events (SAEs)

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

• Adverse events of special interest (AESIs)

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

• Laboratory test related adverse events

  4 days following each dose.

• Geometric Mean Titer(GMT), Geometric Mean Fold Increase (GMI) and Seroconversion Rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody

  from the first dose through 21 days

• GMT, GMI and SCR of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody

  30, 90, 180 and 360 days after the second dose.

Study Arms (3)

20 μg dose of SYS6006 (Aged 18~59 years or 60 years or more)

EXPERIMENTAL

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

Biological: SYS6006 20 μg

30 μg dose of SYS6006 (Aged 18~59 years or 60 years or more)

EXPERIMENTAL

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

Biological: SYS6006 30 μg

Placebo(Aged 18~59 years or 60 years or more)

PLACEBO COMPARATOR

placebo IM, on day 0 and day 21 .

Biological: Placebo

Interventions

SYS6006 20 μg BIOLOGICAL

SARS-CoV-2 mRNA Vaccine

20 μg dose of SYS6006 (Aged 18~59 years or 60 years or more)

SYS6006 30 μg BIOLOGICAL

SARS-CoV-2 mRNA Vaccine

30 μg dose of SYS6006 (Aged 18~59 years or 60 years or more)

Placebo BIOLOGICAL

Placebo

Placebo(Aged 18~59 years or 60 years or more)

Eligibility Criteria

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

You may qualify if:

• Age at the time of the first dose of vaccine: 18 and above;
• Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment;
• Based on the medical history, physical examination and laboratory examination results, the investigator clinically determined the qualified person.
• Has independent judgment, and participate voluntarily and sign an informed consent form.

You may not qualify if:

• Those who meet any of the following criteria must be excluded from this study:
• Has a history of SARS or SARS-CoV-2 infection, or close contact with SARS-CoV-2 infected person( nucleic acid test positive), or living abroad within 30 days before screening;
• Positive for SARS-CoV-2 antibody test;
• History of allergy to paracetamol or vaccination (such as acute allergic reaction, urticaria, dyspnea, angioedema, or abdominal pain);
• Has a history of vaccination with SARS-CoV-2 vaccine, or vaccination with other inactivated or recombinant vaccine within 7 days or received live attenuated vaccine within 14 days before the first dose;
• Has a medical or family history of epilepsy or convulsion, neurological disorders, mental disorders, etc.;
• Is contraindications for intramuscular injection, such as diagnosed thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment, etc.;
• Has known or suspected serious disorders judged by the Investigator, including but not limited to respiratory disorders (pulmonary failure, etc.), liver and kidney disorders, cardiovascular disorders (cardiac failure, severe hypertension, etc.), malignant tumors, infections or allergic skin disorders, HIV infection, or in the acute infection or chronic disease activity period (within 3 days before vaccination);
• Has chronic diseases (such as Down syndrome, sickle cell anemia, neurological disorders and Guillain-Barre syndrome, excluding chronic diseases such as controlled stable diabetes mellitus/hypertension/hyperlipidemia) that are not suitable for this study at the discretion of the Investigator;
• Has known immunological impairment or immunodeficiency diagnosed by hospital before enrollment, or functional asplenia or splenectomy caused by any condition;
• For women of childbearing potential: positive pregnancy test before the enrollment, being in pregnant, breastfeeding, or have a pregnancy plan within 1 year; men: whose spouses is of childbearing potential and has a pregnancy plan within 1 year;
• Is participating or plan to participate in other clinical studies during the study;
• Has received immune enhancement or immunosuppressive therapy within 3 months (continuous oral or instillation for more than 14 days); or received treatment with whole blood, plasma and immunoglobulin within 1 month;
• Is unlikely to adhere to the study procedures or keep appointments at the discretion of the investigators;or has other conditions that are not suitable for participating in this clinical trial.

Sponsors & Collaborators

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

Study Sites (2)

Hebei Provincial Center For Disease Control and Prevention

Shijiazhuang, Hebei, 050024, China

Location

Sir Run Run Hosipital Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

SYS6006 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yuliang Zhao

  Center For Disease Control and Prevention, Hebei Province

  PRINCIPAL INVESTIGATOR

• Jingxin Li

  Jiangsu Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

• Xiang Lu

  Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: June 27, 2022
• First Posted: June 30, 2022
• Study Start: June 28, 2022
• Primary Completion: January 12, 2023
• Study Completion: June 28, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)