A Phase I/II, Double-blinded, Randomized, Placebo-Controlled, Dose Selection Study in Adults to Assess the Safety and Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 405
- 试验地点
- 14
- 主要终点
- Percentage of participants with immediate unsolicited adverse events (AE)
研究概览
简要总结
The purpose of this study is to evaluate the safety and immunogenicity of two investigational vaccines, AZD4117 and AZD5315 to protect against certain strains of avian Influenza A (H5N1 and H7N9 subtypes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking will be secured to the syringe after preparation by unblinded personnel
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, ≥ 18 years of age at the time of signing the informed consent
- •Participants who are medically stable such that, according to the judgement of the Investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrollment
- •Written informed consent and any locally required authorization (eg, HIPAA in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
排除标准
- •History of hypersensitivity to any component of the IMP
- •History of hypersensitivity to penicillin and its derivatives
- •History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis associated with a vaccine
- •Known or suspected congenital or acquired immunodeficiency
- •Abnormal findings on screening laboratory tests
- •Previous history of myocarditis, pericarditis, Guillain-Barré syndrome or any other demyelinating condition
- •Known or suspected autoimmune conditions as determined by history and/or physical examination
- •Receipt of any other type of seasonal influenza vaccination from 14 days before the first dose until 28 days after the administration of the last dose of IMP
- •Receipt of an mRNA vaccine within 28 days before administration of IMP
- •Receipt or expected receipt of any other type of licensed or investigational vaccine within 28 days prior to Visit 1 (D1) or Visit 5 (D58)
- •Receipt of immunoglobulin or blood products within 6 months prior to administration of study intervention or expected receipt during the study
- •Receipt of immune-modifying drugs or immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within 6 months prior to enrollment (or expected receipt during study), or long-term systemic corticosteroid therapy (prednisolone or equivalent at a dose of ≥ 20 mg daily for more than 2 consecutive weeks) within 6 months prior to enrollment or expected receipt during study. Topical/inhaled steroids or short-term oral steroids are permitted
- •Participation in another trial, or receiving interventional Study IMP, in the preceding 90 days or expected receipt of another study intervention (or participation in another trial) during the period of study follow-up
- •Acute (time-limited) or febrile (temperature ≥ 38.0 °C [100.4 °F]) illness/infection within 3 days of intended IMP administration
- •Individuals who have had a previous confirmed or suspected illness from influenza caused by an H5N1 or H7N9 virus
- •Individuals who had household contact with and/or intimate exposure to an individual with laboratory confirmed H5N1 infection, exposure to infected household poultry/ wild birds/cattle or contaminated environments with sick and dead poultry or wild birds or cattle, within 60 days prior to enrollment
- •Female participants who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to IMP administration and until at least 6 months after IMP administration
研究组 & 干预措施
Arm 8: DL2 of AZD5315 >= 65 years of age
Participants will receive DL2 AZD5315.
干预措施: AZD5315 (Biological)
Arm 9: placebo 18 to 64 years of age
Participants will receive placebo.
干预措施: Placebo (Other)
Arm 1: Dosage Level 1 (DL1) of AZD4117 18 to 64 years of age
Participants will receive DL1 AZD4117.
干预措施: AZD4117 (Biological)
Arm 2: Dosage Level 2 (DL2) of AZD4117 18 to 64 years of age
Participants will receive DL2 AZD4117.
干预措施: AZD4117 (Biological)
Arm 3: DL1 of AZD4117 >= 65 years of age
Participants will receive DL1 AZD4117.
干预措施: AZD4117 (Biological)
Arm 4: DL2 of AZD4117 >= 65 years of age
Participants will receive DL2 AZD4117.
干预措施: AZD4117 (Biological)
Arm 5: DL1 of AZD5315 18 to 64 years of age
Participants will receive DL1 AZD5315.
干预措施: AZD5315 (Biological)
Arm 6: DL2 of AZD5315 18 to 64 years of age
Participants will receive DL2 AZD5315.
干预措施: AZD5315 (Biological)
Arm 7: DL1 of AZD5315 >= 65 years of age
Participants will receive DL1 AZD5315.
干预措施: AZD5315 (Biological)
Arm 10: placebo >= 65 years of age
Participants will receive placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of participants with immediate unsolicited adverse events (AE)
时间窗: Within 30 minutes after dosing
Percentage of participants with injection site and systemic solicited adverse reactions (AR)
时间窗: Through 7 days after dosing
Percentage of participants with unsolicited AE
时间窗: Through 28 days after the last dose
Percentage of participants with serious adverse events (SAE)
时间窗: Through 12 months after the last dose
Percentage of participants with medically attended adverse events (MAAE)
时间窗: Through 12 months after the last dose
Percentage of participants with adverse events of special interest (AESI)
时间窗: Through 12 months after the last dose
Proportion of participants achieving ≥ 1:40 HAI titer post-IMP administration
时间窗: Day 58
A binary endpoint, defined as ≥ 1:40 HAI titer post-IMP administration.
Proportion of participants achieving seroconversion post-IMP administration
时间窗: Day 58
Seroconversion status, defined as either a pre-IMP administration HAI titer \< 1:10 and a post-IMP administration HAI titer ≥ 1:40, or a pre-IMP administration titer ≥ 1:10 and 4-fold increase in post-IMP administration titer.
次要结局
- Geometric mean titer (GMT) of HAI antibody(Days 1 to 389)
- Geometric mean fold-rise (GMFR) of HAI antibody titers from baseline(Days 29 to 389)
- Proportion of participants achieving a ≥1:40 HAI titer post-IMP administration(Days 29 to 389)
- Proportion of participants achieving seroconversion post-IMP administration(Days 29 to 389)