A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novavax
- 入组人数
- 911
- 试验地点
- 48
- 主要终点
- Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMEUs
研究概览
简要总结
This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373).The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive.
详细描述
This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373). The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Participants will be screened at baseline with the goal of enrolling approximately 900 previously vaccinated participants. Participants will be randomized 1:1:1 to receive 1 dose of the vaccine from 1 of 3 different lots, given on Day 1, at a dose level of 5 µg of antigen with 50 µg of Matrix-M adjuvant. All participants will remain on study for immunogenicity and safety data collection through 28 days following the 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be included in this study, each individual must satisfy all of the following criteria:
- •Adults 18 to 49 years of age, inclusive, at screening
- •Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
- •Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of study (EOS) visit OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through the EOS visit.
- •Is medically stable, as determined by the investigator (based on review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the study vaccination
- •Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
- •Note: For participants who become hospitalized with coronavirus disease 2019 (COVID-19), participation in investigational treatment studies is permitted.
- •Documented receipt of either 2 or 3 doses of the investigational Novavax vaccine with Matrix-M adjuvant (NVX- CoV2373); OR documented receipt of a full course of an FDA-authorized/approved COVID-19 vaccine; OR documented receipt of a full course of heterologous COVID-19 vaccines mentioned above. The most recent dose must have been administered at least 6 months prior to study vaccination.
排除标准
- •Participants meeting any of the following criteria will be excluded from the study.
- •History of laboratory-confirmed (by polymerase chain reaction [PCR] or rapid antigen test)COVID-19 infection ≤ 4 months prior to randomization.
- •Current participation in research involving receipt of an investigational product (drug/biologic/device).
- •Any known allergies or history of anaphylaxis to the active substance or any of the other ingredients contained in the investigational product.
- •Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression.
- •Received any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccine which may be received 4 days prior to study vaccine, or rabies vaccine which may be received at any time if medically indicated.
- •Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
- •Active cancer (malignancy) on chemotherapy that is judged to cause significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator).
- •Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EOS visit.
- •Suspected or known history of alcohol abuse or drug addiction within 3 months prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
- •Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
- •Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization [CRO], and study site personnel involved in the conduct or planning of the study).
- •Participants with a history of myocarditis or pericarditis.
研究组 & 干预措施
Lot 3
1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.
干预措施: NVX-Cov2373 (Drug)
Lot 1
1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.
干预措施: NVX-Cov2373 (Drug)
Lot 2
1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 1.
干预措施: NVX-Cov2373 (Drug)
结局指标
主要结局
Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMEUs
时间窗: Day 29
IgG geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.
Serum Immunoglobulin G (IgG) Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Geometric Mean ELISA Unit [GMEUs]
时间窗: Baseline (Day 1) and Day 29
Serum Immunoglobulin G (IgG) geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.
次要结局
- MN50 geometric mean titers (GMTs) to the SARS-CoV-2 expressed as GMTs(Day 29)
- Serum IgG antibody levels expressed as seroconversion rate (SCR)(Day 29)
- Incidence and relationship of SAEs(Day 0 to Day 29)
- MN50 GMTs to the SARS-CoV-2 expressed as SCR(Day 29)
- Human Angiotensin-Converting Enzyme 2 (hACE2) inhibition assay titers GMT to the SARS-CoV-2 expressed as GMT(Day 29)
- hACE2 inhibition assay titers to the SARS-CoV-2 expressed as SCR(Day 29)
- Incidence and severity of MAAEs(Day 0 to Day 29)
- Incidence and severity of AESIs(Day 0 to Day 29)
- Serum IgG Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Seroconversion Rate (SCR)(Day 29)
- Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as Geometric Mean Titer [GMT](Baseline (Day 1) to Day 29)
- Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as SCR(Day 29)
- hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as GMT(Baseline (Day 1) to Day 29)
- Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR(Day 29)
- Number of Participants With Medically Attended Adverse Event(s) (MAAEs), Adverse Event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)(Day 1 to Day 29)
- Incidence and Severity of MAAEs Through Day 29(Day 29)
- Number of Participants With Unsolicited Treatment-Emergent Adverse Events by COVID-19(Day 29)