Clinical Trial of SARS-CoV-2 mRNA Vaccine in China

NCT05364047 | Unknown Phase 1

• 1 other identifier: LVRNA009-I-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events including solicited adverse event（AE） and unsolicited adverse event（AE）

  Solicited AE--14 days post-vaccination, common reactions at the vaccination site and non-vaccination site pre-listed on the subject's diary card and electronic case report form（eCRF）, including pain, induration, swelling, rash, flushing, itching, cellulitis at injection site, fever, headache, chills, anorexia, diarrhea, nausea, vomiting, fatigue, weakness, arthralgia, acute allergic reaction, muscle pain at non-inoculation site. non-solicited AE --28 days after vaccination, all adverse events other than solicited AE and after 14 days.

  Solicited AE -14 days post-vaccination, all adverse events other than solicited AE - 28 days after vaccination

• Incidence of adverse events associated with the experimental vaccine

  Incidence of adverse events associated with the experimental vaccine within 28 days after each dose or full vaccination.

  28 days after each dose or full vaccination

Secondary Outcomes (6)

• Incidence of grade ≥3 adverse events

  28 days after each dose or full vaccination

• Incidence of grade ≥3 adverse events associated with the experimental vaccine

  28 days after each dose or full vaccination

• Withdrawal from the trial due to adverse events

  28 days after each dose or full vaccination

• Incidence of serious adverse event（SAE）

  28 days, 3 months, 6 months and 12 months after primary immunization to full immunization

• Incidence of SAEs associated with the experiment vaccine

  28 days, 3 months, 6 months and 12 months after primary immunization to full immunization

Other Outcomes (5)

• Positive conversion rate of anti-2019 novel coronavirus S protein-specific antibody (IgG) (average titer increase ≥4 times compared with baseline)

  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

• Geometric mean titer (GMT) of anti-2019 novel coronavirus S protein-specific antibody (IgG) and mean fold increase compared with baseline

  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

• Positive conversion rate of anti-2019 novel coronavirus neutralizing antibody GMT （average titer increase ≥4 times compared with baseline)

  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

Study Arms (6)

Low-dose group, 18-59 years of age

OTHER

The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 25μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.

Biological: Low-dose of LVRNA009; Other: Placebo

Middle-dose group, 18-59 years of age

OTHER

The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 50μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.

Biological: Middle-dose of LVRNA009; Other: Placebo

High-dose group, 18-59 years of age

OTHER

The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 100μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.

Biological: High-dose of LVRNA009; Other: Placebo

Low-dose group, over 60 years of age

OTHER

The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 25μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.

Biological: Low-dose of LVRNA009; Other: Placebo

Middle-dose group, over 60 years of age

OTHER

The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 50μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.

Biological: Middle-dose of LVRNA009; Other: Placebo

High-dose group, over 60 years of age

OTHER

The subjects were divided into the experimental group and the placebo group according to 3:1. The experimental group was inoculated with a dose of 100μg mRNA vaccine, and the placebo group was inoculated with a dose of placebo.

Biological: High-dose of LVRNA009; Other: Placebo

Interventions

Low-dose of LVRNA009 BIOLOGICAL

25μg/person

Low-dose group, 18-59 years of age; Low-dose group, over 60 years of age

Middle-dose of LVRNA009 BIOLOGICAL

50μg/person

Middle-dose group, 18-59 years of age; Middle-dose group, over 60 years of age

High-dose of LVRNA009 BIOLOGICAL

100μg/person

High-dose group, 18-59 years of age; High-dose group, over 60 years of age

Placebo OTHER

0.5ml/person

High-dose group, 18-59 years of age; High-dose group, over 60 years of age; Low-dose group, 18-59 years of age; Low-dose group, over 60 years of age; Middle-dose group, 18-59 years of age; Middle-dose group, over 60 years of age

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

You may not qualify if:

• 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;
• Anyone who is allergic to any vaccines, drugs, foods or known excipients (Dlin-MC3-DMA, cholesterol, distearoylphosphatidylcholine, PEG2000-DMG);
• Have a history of SARS virus infection;
• 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;
• Patients have a medical history or family history of epilepsy, convulsions or convulsions, neurological diseases and mental diseases;
• There are contraindications for intramuscular injection, such as: thrombocytopenia that has been diagnosed, any coagulation disorder or receiving anticoagulant treatment, etc.;
• 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);
• 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 );
• Patients with known immunological impairment or low immunological function diagnosed by the hospital before enrollment, or functional asplenia or splenectomy caused by any situation;
• 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;
• 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;
• 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;
• 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;
• 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);
• Patients donated blood \>=400 ml within 28 days before screening, or received whole blood, plasma and immunoglobulin therapy within 6 months before screening;

Sponsors & Collaborators

• AIM Vaccine Co., Ltd.: lead
• Shulan (Hangzhou) Hospital: collaborator
• Yuncheng Central Hospital: collaborator

Study Sites (3)

Xiangya Boai Rehabilitation Hospital

Changsha, Hunan, 410329, China

Location

Yuncheng Central Hospital

Yuncheng, Shanxi, 044099, China

Location

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, 310022, China

Location

Related Publications (1)

• Chen GL, Yu XY, Luo LP, Zhang F, Dai XH, Li N, Shen ZW, Wu KQ, Lou DF, Peng CG, Jin TH, Huang YM, Shao X, Liu Q, Jiang Q, Guo T, Cao F, Zhu JR, Wu XH, Pei RJ, Deng F, Jiang GP, Li YH, Gao HN, He JX, Zhong-Chen, Peng YC, Li LJ. Phase I study of a non-S2P SARS-CoV-2 mRNA vaccine LVRNA009 in Chinese adults. Vaccine. 2023 Nov 22;41(48):7297-7306. doi: 10.1016/j.vaccine.2023.10.065. Epub 2023 Nov 3.

  PMID: 37925316 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

LVRNA009 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

• Lanjuan Li

  Shulan (Hangzhou) Hospital

  PRINCIPAL INVESTIGATOR

• Guiling Chen

  Shulan (Hangzhou) Hospital

  PRINCIPAL INVESTIGATOR

• Fengli Zhao

  Yuncheng Central Hospital

  PRINCIPAL INVESTIGATOR

• Jinlian Bi

  Xiangya Boai Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 6, 2022
• Study Start: July 31, 2021
• Primary Completion: October 14, 2022
• Study Completion: October 1, 2023
• Last Updated: December 5, 2022

Record last verified: 2022-11

Locations

CN (3)