NCT05812014招募中3 期
A Multi-center, Randomized, Blinded, Placebo-controlled, Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 Bivalent mRNA Vaccine (LVRNA021) as Booster in Participants Aged 18 Years and Older Who Completed Primary/1 Booster Dose(s) of SARS-CoV-2 Vaccination
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 9,800
- 试验地点
- 1
- 主要终点
- Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19
研究概览
简要总结
This is a multi-center, randomized, blinded, placebo-controlled, phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) as booster in participants aged 18 years and older who completed primary/1 booster dose(s) of SARS-CoV-2 vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and older;
- •Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on his/her own due to illiteracy, an impartial witness is needed);
- •Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures;
- •Female participants of childbearing potential or partners of male participants: voluntarily agree to use effective contraception with their partners prior to the first vaccination and must agree to continue such precautions during the study until 3 months after booster vaccination [Effective contraception includes oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, hormonal patches, intrauterine devices (IUDs), sterilization, abstinence, condoms (for male), diaphragms, cervical caps, etc.);
- •For female participants: without childbearing potential (amenorrhea for at least 1 year or documented surgical sterilization) or have used effective contraception with a negative pregnancy test before booster vaccination in this study；
- •On the day of vaccination and 24 hours prior to vaccination, axillary temperatures<37.3°C/99.1°F;
- •Healthy participants or participants with mild underlying disease [in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study];
- •Participants who have received primary/1 booster dose(s) of SARS-CoV-2 vaccination (including primary series of inactivated vaccine, mRNA vaccine, adenovirus vaccine or 1 homologous/heterologous booster), with the last dose received at least 6 months before enrolment. Documented confirmation of prior SARS-CoV-2 vaccination receipt must be obtained prior to randomization;
排除标准
- •History of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or other coronavirus infections at any time;
- •History of hepatitis A, hepatitis B, hepatitis C, syphilis infection based on medical inquiry.;
- •History of severe adverse reaction associated with a vaccine or drug and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s);
- •Receipt of medications intended to treat COVID-19 within 6 months;
- •Virologically confirmed SARS-CoV-2 diagnosis within 6 months before screening visit;
- •Positive nasopharyngeal/oropharyngeal swab SARS-CoV-2 RT-PCR test result at screening;
- •Positive HIV test result at screening;
- •A history or family history of convulsions, epilepsy, encephalopathy and psychosis;
- •Malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period;
- •Asplenia or functional asplenia, complete or partial splenectomy from any cause;
- •Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, epidural, or topical (skin or eyes) corticosteroids are permitted;
- •Any other licensed vaccines given within 28 days prior to vaccination, planned administration of any other vaccines within 28 days after vaccination, or planned administration of other COVID-19 vaccines during the entire study duration;
- •Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before vaccine administration, or receipt of any passive antibody therapy specific to COVID-19, from 90 days before vaccine administration, or planned receipt throughout the study;
- •Blood donation or blood loss ≥ 450 mL within 1 month prior to enrollment or planned to donate blood during the study period;
- •Participation in other studies involving study intervention within 28 days prior to study entry, and/or during the study;
- •Women who are pregnant or breastfeeding;
- •Participants deemed unsuitable for participation in this study based on the investigator's assessment.
研究组 & 干预措施
Control Group
Placebo Comparator
干预措施: 0.9% sodium chloride solution (Drug)
Study Vaccine Group
Experimental
干预措施: SARS-CoV-2 Bivalent mRNA vaccine (LVRNA021) (Biological)
结局指标
主要结局
Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19
时间窗: 14 days after vaccination or placebo
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis occurring from 14 days after booster vaccination.
次要结局
- Person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19(14 days after vaccination or placebo)
- Person-year incidence density of first episodes of virologically-confirmed cases of COVID-19(14 days after vaccination or placebo)
- Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 for participants in different age strata (18-59 years, ≥ 60 years)(14 days after vaccination or placebo)
- Incidence of each solicited (local and systemic) AE in all participants.(within 14 days after vaccination or placebo)
- Severity of each solicited (local and systemic) AE in all participants.(within 14 days after vaccination or placebo)
- Duration of each solicited (local and systemic) AE in all participants.(within 14 days after vaccination or placebo)
- Severity of unsolicited AEs in all participants.(0-28 days after vaccination or placebo)
- Incidence of unsolicited AEs in all participants.(0-28 days after vaccination or placebo)
- Causality of unsolicited AEs in all participants.(0-28 days after vaccination or placebo)
- Incidence of SAEs in all participants.(within 12 months after vaccination or placebo)
- Severity of SAEs in all participants.(within 12 months after vaccination or placebo)
- SCR of S-protein IgG antibodies in subjects in the immunization subgroup.(14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo)
- Person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19(14 days after vaccination or placebo)
- Incidence of AESIs in all participants.(within 12 months after vaccination or placebo)
- Severity of AESIs in all participants.(within 12 months after vaccination or placebo)
- Incidence of pregnancy events in all participants.(within 12 months after vaccination or placebo)
- Severity of pregnancy events in all participants.(within 12 months after vaccination or placebo)
- Causality of SAEs, AESIs, and pregnancy events in all participants.(within 12 months after vaccination or placebo)
- Geometric mean titer (GMT)of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.(14 days,28 days,3 months and 6 months after vaccination or placebo)
- Seroconversion rate (SCR) of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.(14 days,28 days,3 months and 6 months after vaccination or placebo)
- Geometric mean Increase (GMI) of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.(14 days,28 days,3 months and 6 months after vaccination or placebo)
- GMT of S-protein IgG antibodies in subjects in the immunization subgroup.(14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo)
- GMI of S-protein IgG antibodies in subjects in the immunization subgroup.(14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo)
研究者
研究点 (1)
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