Clinical trial NCT05364047: Clinical Trial of SARS-CoV-2 mRNA Vaccine in China
Official title: Phase I Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) in Chinese People Aged 18 Years and Over
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: AIM Vaccine Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shulan (Hangzhou) Hospital
name: Yuncheng Central Hospital
First posted: 2022-05-06
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a phase I clinical trial. The investigators intent to evaluate the safety, tolerability and preliminary immunogenicity of SARS-CoV-2 mRNA vaccine (LVRNA009) in Chinese people aged 18 years and over.


Eligibility criteria: Inclusion Criteria:

1. Age at the time of the first dose of vaccine: aged 18 to 59 years (including boundary values) in the adult group, \>=60 years old in the older group, regardless of gender;
2. Axillary body temperature is less than 37.3 ℃ on the day of enrollment;
3. Based on the medical history and relevant physical examination and laboratory examination results, the investigator clinically determined that the patient was in good health;
4. Subjects have independent judgment ability, can read, understand and complete vaccination diary cards, and they participate voluntarily and sign an informed consent form.

Exclusion Criteria:

1. The subject has a history of SARS-CoV-2 infection, or has a history of contact with SARS-CoV-2 infected persons (nucleic acid test positive) or suspected infected persons within 30 days before screening, or living abroad within 30 days before screening history;
2. Anyone who is allergic to any vaccines, drugs, foods or known excipients (Dlin-MC3-DMA, cholesterol, distearoylphosphatidylcholine, PEG2000-DMG);
3. Have a history of SARS virus infection;
4. Upon questioning, have a history of COVID-19 vaccination, or have received other inactivated vaccines within 14 days before screening, and received live attenuated vaccines within 28 days;
5. Patients have a medical history or family history of epilepsy, convulsions or convulsions, neurological diseases and mental diseases;
6. There are contraindications for intramuscular injection, such as: thrombocytopenia that has been diagnosed, any coagulation disorder or receiving anticoagulant treatment, etc.;
7. The investigator judges that he is known or suspected of having more serious diseases at the same time, including but not limited to: respiratory diseases (tuberculosis, lung failure, etc.), liver and kidney diseases, cardiovascular diseases (heart failure, severe hypertension, etc.), Malignant tumor, infection or allergic skin disease, HIV infection (test report can be provided), or during the active period of acute infection or chronic disease (within 3 days before vaccination);
8. Congenital malformations, developmental disorders, or chronic diseases that the investigator judges are not suitable for participating in this study (such as Downs syndrome, sickle cell anemia or neurological disorders, Guillain-Barre syndrome, etc.), excluding stable diabetes/hypertension );
9. Patients with known immunological impairment or low immunological function diagnosed by the hospital before enrollment, or functional asplenia or splenectomy caused by any situation;
10. There is evidence that they are smokers (smokers \>=10 cigarettes/day), alcoholics (alcohol consumption \>=4 units/day), drug abusers, and those who do not agree to quit smoking or drinking during the trial;
11. Positive SARS-CoV-2 nucleic acid test and/or positive antibody test before the first dose of vaccine, and/or abnormal imaging examination (small patchy shadow and interstitial change, obvious peripheral lung zone, ground-glass shadow, infiltrating shadow, lung consolidation, etc.), and/or decreased lymphocyte count;
12. Female: those who have a positive blood pregnancy test, are pregnant, breastfeeding, or have a pregnancy plan within one year; men: whose spouse has a pregnancy plan within one year;
13. Patients have participated in other clinical trials (drugs, biological products or devices) within 3 months before the first dose of vaccine, or plan to participate in other clinical trials during the research period;
14. Patients received immune enhancement or immunosuppressive therapy within 6 months before the first dose of vaccine (continuous oral or instillation for more than 14 days);
15. Patients donated blood \>=400 ml within 28 days before screening, or received whole blood, plasma and immunoglobulin therapy within 6 months before screening;
16. Currently receiving research drug treatment to prevent COVID-19;
17. Patients are taking antipyretic, analgesic and anti-allergic drugs within 3 days before enrollment;
18. The investigator judges that the subjects cannot follow the research procedures, comply with the agreement, or plan to permanently relocate from the area before the end of the research, or plan to leave the local area for a long time during the scheduled visit period;
19. The relevant staff involved in this study or their immediate family members (such as spouses, parents, siblings or children).
20. According to the investigator's judgment, there are other situations that are not suitable for participating in this clinical trial.

Primary outcomes:
measure: Incidence of adverse events including solicited adverse event（AE） and unsolicited adverse event（AE）
timeFrame: Solicited AE -14 days post-vaccination, all adverse events other than solicited AE - 28 days after vaccination
measure: Incidence of adverse events associated with the experimental vaccine
timeFrame: 28 days after each dose or full vaccination
Secondary outcomes:
measure: Incidence of grade ≥3 adverse events
timeFrame: 28 days after each dose or full vaccination
measure: Incidence of grade ≥3 adverse events associated with the experimental vaccine
timeFrame: 28 days after each dose or full vaccination
measure: Withdrawal from the trial due to adverse events
timeFrame: 28 days after each dose or full vaccination
measure: Incidence of serious adverse event（SAE）
timeFrame: 28 days, 3 months, 6 months and 12 months after primary immunization to full immunization
measure: Incidence of SAEs associated with the experiment vaccine
timeFrame: 28 days, 3 months, 6 months and 12 months after primary immunization to full immunization
measure: Incidence of clinically significant abnormalities in laboratory tests
timeFrame: 28 days after each dose or full vaccination
Other outcomes:
measure: Positive conversion rate of anti-2019 novel coronavirus S protein-specific antibody (IgG) (average titer increase ≥4 times compared with baseline)
timeFrame: 14 days and 28 days after the first dose；7 days, 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
measure: Geometric mean titer (GMT) of anti-2019 novel coronavirus S protein-specific antibody (IgG) and mean fold increase compared with baseline
timeFrame: 14 days and 28 days after the first dose；7 days, 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
measure: Positive conversion rate of anti-2019 novel coronavirus neutralizing antibody GMT （average titer increase ≥4 times compared with baseline)
timeFrame: 14 days and 28 days after the first dose；7 days, 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
measure: Geometric mean titer (GMT) of anti-2019 novel coronavirus neutralizing antibody and mean fold increase compared with baseline
timeFrame: 14 days and 28 days after the first dose；7 days, 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
measure: Level of specific cellular immune response against 2019 novel coronavirus（CD4+、CD8+ and IL-2、IL-4、IL-6、IL-10、IFN-γ and TNF-α）
timeFrame: 14 days and 28 days after the first dose, 7 days, 14 days, 28 days, 3 months, 6 months and 12 months after full vaccination
Locations:
city: Changsha
country: China
facility: Xiangya Boai Rehabilitation Hospital
state: Hunan
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
state: Shanxi
city: Hangzhou
country: China
facility: Shulan (Hangzhou) Hospital
state: Zhejiang
Study officials:
affiliation: Shulan (Hangzhou) Hospital
name: Lanjuan Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Shulan (Hangzhou) Hospital
name: Guiling Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Yuncheng Central Hospital
name: Fengli Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: Xiangya Boai Rehabilitation Hospital
name: Jinlian Bi
role: PRINCIPAL_INVESTIGATOR
References: