Phase I, Randomized, Modified Double-blind, Parallel-group, Active-controlled, Multi-arm, Dose-escalation Study to Assess the Safety and Immunogenicity of Monovalent mRNA NA Vaccine in Adult Participants 18 Years of Age and Older
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 6
- 主要终点
- Number of participants with immediate adverse events
研究概览
简要总结
This is a Phase I, first-in-human, randomized, modified double-blind, active-controlled, dose-escalation study to assess the safety and immunogenicity of up to 3 dose levels of mRNA NA vaccines, administered as a single IM injection in healthy adults aged 18 years and older. Two age groups, 18 to 64 years and ≥65 years, will be included in this study.
详细描述
This study will include a screening visit, 6 study visits occurring on Days 1, 3, 9, 29, 91, and 181, and a safety follow-up telephone call on Day 366.
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, Investigator, Outcomes Assessor)
盲法说明
This study will be blinded to participants, investigators/sub-investigators, outcomes assessors, laboratory personnel, and the sponsor study staff (with the exception noted for study staff involved in the ESDRs). Study staff involved in the ESDRs will be unblinded to group assignment of participants in the sentinel safety cohorts. After the ESDRs are performed for the sentinel safety cohorts, the SMT will continue monitoring the safety aspects of the study as part of blinded periodic safety reviews. Those preparing/administering the study interventions will be unblinded.
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
- •Aged 18 years or older on the day of inclusion.
- •A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- •Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR
- •Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration
- •A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours before administration of study intervention.
- •Informed consent form has been signed and dated.
排除标准
- •Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- •Known systemic hypersensitivity to any of the study intervention components; history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- •Moderate or severe acute illness/infection (according to investigator judgement) or febrile illness (temperature ≥100.4°F) on the day of study intervention administration.
- •Have known or recently active (12 months) neoplastic disease or a history of any hematologic malignancy.
- •Have any diagnosis, current or past, of autoimmune disease.
- •Body mass index of 40 kg/m2 or higher.
- •Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
- •Have taken high-dose inhaled corticosteroid (≥500 μg of fluticasone) within 6 months prior to study vaccination.
- •Self-reported or documented seropositivity for HIV, hepatitis B virus, or hepatitis C virus.
研究组 & 干预措施
Group 1 mRNA NA: Low dose Level
Participants will receive a low dose of mRNA vaccine
干预措施: mRNA NA vaccine (Biological)
Group 2 mRNA NA: Medium dose level
Participants will receive a medium dose of mRNA vaccine
干预措施: mRNA NA vaccine (Biological)
Group 3 mRNA NA: High dose level
Participants will receive a high dose of mRNA vaccine
干预措施: mRNA NA vaccine (Biological)
Group 4: QIV-HD
Participants will receive QIV-HD (high dose quadrivalent influenza) vaccine
干预措施: High Dose Quadrivalent Influenza Vaccine (Biological)
结局指标
主要结局
Number of participants with immediate adverse events
时间窗: Within 30 minutes after vaccination
Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Number of participants with solicited injection site or systemic reaction
时间窗: From Day 1 to Day 8
Number of participants with adverse events of special interest
时间窗: From Day 1 to Day 366
Adverse events of special interest are collected throughout the study
Number of patients with clinically significant changes in clinical laboratory tests
时间窗: From Day 1 to Day 8
Laboratory tests include hematology: complete blood count (CBC) with differential, platelet count, coagulation panel (prothrombin time and PTT) and serum chemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total and fractionated bilirubin, C-reactive protein, serum creatinine, and blood urea nitrogen
Number of participants with unsolicited adverse events
时间窗: From Day 1 to Day 29
Unsolicited (spontaneously reported) adverse events not fulfilling criteria for solicited reactions
Number of participants with serious adverse events
时间窗: From Day 1 to Day 366
Serious adverse events are collected throughout the study
次要结局
- Individual Neuraminidase inhibition (NAI) titer(Day 1 and Day 29)
- Percentage of participants with detectable antibody titers greater than or equal to (≥) 10 [1/dil](Day 1 and Day 29)
- Neuraminidase inhibition (NAI) Antibodies at Day 1 and 29(Day 1 and 29)
- 2-fold and 4-fold rise in NAI antibody titers(From Day 1 to Day 29)