Phase Ia/Ib, Randomized, Double Blinded, Dose Escalation Trial to Evaluate the Safety and Immunogenicity in Healthy European and Burkinabe Adults of a Placental Malaria Vaccine Candidate (PRIMVAC) Formulated With Alhydrogel ® or GLA-SE
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Proportion of volunteers with treatment-related adverse events as assessed by FDA scale and the INYVAX EC FP7 Brighton Collaboration Foundation
研究概览
简要总结
The primary objective of the study is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and Burkinabe adults.
The safety and the tolerability of the vaccine will be assessed on the rate of solicited and unsolicited events/reactions The safety profile will included local and systemic reactions/events as well as the biological safety, based on a clinically significant change of the baseline value of the main biological criteria
详细描述
The project aims are:
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Primary objective is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of the PRIMVAC vaccine adjuvanted either with Alhydrogel® or GLA-SE, and administered at D0, D28 and D56 in healthy European and Burkinabe adults.
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Secondary objectives are to assess:
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the humoral immune response to the PRIMVAC vaccine antigen (VAR2CSA) by measuring the variation in the level of total IgG and the level of the isotypic subtypes capable of recognizing the native antigen.
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the cellular immune response by measuring:
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the number of T cell secreting IL5 and IFNg following an ex-vivo stimulation with the vaccine antigen
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the B lymphocyte phenotypes isolated from PBMC
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Exploratory objectives are:
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To explore the quality of the humoral immune response by the measure of the capability of the antibodies specific to the vaccine antigen to:
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A1:Primvac 20 µg +alhydrogel
Group A1: 3 European volunteers 0.5 ml intramuscular injection: 20 µg Primvac+ 0.85 mg Alhydrogel®
Vaccination schedule: D0, D28 and D56
干预措施: PRIMVAC (Biological)
Group A1:Primvac 20 µg +alhydrogel
Group A1: 3 European volunteers 0.5 ml intramuscular injection: 20 µg Primvac+ 0.85 mg Alhydrogel®
Vaccination schedule: D0, D28 and D56
干预措施: Alhydrogel (Biological)
Group A2:Primvac 20 µg +GLA-SE
Group A2: 3 European volunteers 0.5 ml intramuscular injection:20 µg Primvac+ 2.5 µg GLA-SE Vaccination schedule: D0, D28 and D56
干预措施: PRIMVAC (Biological)
Group A2:Primvac 20 µg +GLA-SE
Group A2: 3 European volunteers 0.5 ml intramuscular injection:20 µg Primvac+ 2.5 µg GLA-SE Vaccination schedule: D0, D28 and D56
干预措施: GLA-SE (Biological)
Group B1:Primvac 50 µg +alhydrogel
Group B1: 6 European volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 0.85 mg Alhydrogel®
Vaccination schedule: D0, D28 and D56
干预措施: PRIMVAC (Biological)
Group B1:Primvac 50 µg +alhydrogel
Group B1: 6 European volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 0.85 mg Alhydrogel®
Vaccination schedule: D0, D28 and D56
干预措施: Alhydrogel (Biological)
Group B2:Primvac 50 µg +GLA-SE
Group B2: 6 European volunteers 0.5 ml intramuscular injection:50 µg Primvac+ 2.5 µg GLA-SE Vaccination schedule: D0, D28 and D56
干预措施: PRIMVAC (Biological)
Group B2:Primvac 50 µg +GLA-SE
Group B2: 6 European volunteers 0.5 ml intramuscular injection:50 µg Primvac+ 2.5 µg GLA-SE Vaccination schedule: D0, D28 and D56
干预措施: GLA-SE (Biological)
Group C1:Primvac 50 µg +alhydrogel
Group C1: 10 African volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 0.85 mg Alhydrogel®
Vaccination schedule: D0, D28 and D56
干预措施: PRIMVAC (Biological)
Group C1:Primvac 50 µg +alhydrogel
Group C1: 10 African volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 0.85 mg Alhydrogel®
Vaccination schedule: D0, D28 and D56
干预措施: Alhydrogel (Biological)
Group C2: Primvac 50 µg +GLA-SE
Group C2: 10 African volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 2.5 µg GLA-SE
Vaccination schedule: D0, D28 and D56
干预措施: PRIMVAC (Biological)
Group C2: Primvac 50 µg +GLA-SE
Group C2: 10 African volunteers 0.5 ml intramuscular injection: 50 µg Primvac+ 2.5 µg GLA-SE
Vaccination schedule: D0, D28 and D56
干预措施: GLA-SE (Biological)
Group C3: Placebo
Group C3: 5 African volunteers 0.5 ml intramuscular injection: NaCl 0.9% (placebo)
Vaccination schedule: D0, D28 and D56
干预措施: Placebo (Biological)
Group D1:Primvac 100 µg +alhydrogel
Group D1: 10 African volunteers 0.6 ml intramuscular injection: 100µg Primvac+ 0.85 mg Alhydrogel®
Vaccination schedule: D0, D28 and D56
干预措施: PRIMVAC (Biological)
Group D1:Primvac 100 µg +alhydrogel
Group D1: 10 African volunteers 0.6 ml intramuscular injection: 100µg Primvac+ 0.85 mg Alhydrogel®
Vaccination schedule: D0, D28 and D56
干预措施: Alhydrogel (Biological)
Group D2: Primvac 100 µg +GLA-SE
Group D2: 10 African volunteers 0.6 ml intramuscular injection: 100 µg Primvac+ 2.56 µg GLA-SE
Vaccination schedule: D0, D28 and D56
干预措施: PRIMVAC (Biological)
Group D2: Primvac 100 µg +GLA-SE
Group D2: 10 African volunteers 0.6 ml intramuscular injection: 100 µg Primvac+ 2.56 µg GLA-SE
Vaccination schedule: D0, D28 and D56
干预措施: GLA-SE (Biological)
Group D3: placebo
Group D3: 5 African volunteers 0.6 ml intramuscular injection: NaCl 0.9% (placebo)
Vaccination schedule: D0, D28 and D56
干预措施: Placebo (Biological)
结局指标
主要结局
Proportion of volunteers with treatment-related adverse events as assessed by FDA scale and the INYVAX EC FP7 Brighton Collaboration Foundation
时间窗: 35 days
Grade 3 or higher clinical or laboratory ARI and persisting at Grade 3 for \> 48 hours between D0 and D35.
次要结局
- Proportion of volunteer with at least one Serious Adverse Event Following Immunization (SAEFI) for the entire duration of the study(14 months)
- Proportion of volunteer with at least one Adverse Event Following Immunization (AEFI) measured between M3 and the end of the study (only phase Ia)(11 months)
- Variation in humoral immune response to the vaccine antigen assessed by ELISA(3 months)
- Proportion of volunteer with at least one of Adverse Event Following Immunization (AEFI) measured until 1 month post-dose 3(3 months)
- Cellular immune responses to the vaccine antigen by Elispot(63 days)
- Cellular immune responses to the vaccine antigen by FACS(63 days)