Phase 2 Trial of Safety, Immunogenicity, and Efficacy Against Plasmodium Falciparum Malaria of PfSPZ Vaccine in Children in Mali
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanaria Inc.
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Number of Participants With Possibly, Probably, or Definitely Related Serious Adverse Events (SAEs)
研究概览
简要总结
In this randomized, double-blind, placebo-controlled trial, 268 healthy Malian children aged 6-10 years, residing in Bancoumana and surrounding villages, will be administered three doses of 9.0x10^5 Pf sporozoites (PfSPZ) of PfSPZ Vaccine (or placebo) at 1, 8, and 29-days using direct venous inoculation (DVI).
The study is composed of a single cohort with two arms (categorized by placebo control/experimental groups) designed to assess the safety, immunogenicity and protective efficacy of PfSPZ Vaccine.
All subjects will receive artemether-lumefantrine (AL) approximately 1- 2 weeks before the first dose of PfSPZ Vaccine or normal saline for clearance of Pf parasitemia. Vaccinated participants and non-immunized controls will be followed for safety and monitored for development of parasitemia through the natural malaria transmission season to estimate vaccine efficacy (VE).
详细描述
This phase 2 study will enroll healthy Malian children between 6 and 10 years of age residing in Bancoumana and surrounding villages to participate in a randomized, double blind, placebo- controlled study to assess the safety, immunogenicity and protective efficacy of PfSPZ Vaccine.
Participants will be immunized with a 3-dose series of 9.0 x10^5 PfSPZ of PfSPZ Vaccine or normal saline (placebo) at 1, 8, and 29 days. Subjects will be screened for eligibility for enrollment. Enrollment will begin with AL dosing approximately 1-2 weeks prior to their first dose of vaccine. Volunteers will be randomized into two arms (1 vaccine arm, 1 control arm) in a 1:1 ratio.
Vaccinated subjects and controls will then be followed for safety and assessment for malaria infection during the subsequent malaria transmission season.
268 children between the ages of 6 and 10 years old inclusive will be enrolled as follows:
Arm 1(PfSPZ Vaccine): (n = 134) children ages 6 - 10 will receive three doses of PfSPZ Vaccine (9.0x10^5 PfSPZ) via direct venous inoculation (DVI) at 1, 8, and 29 days
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blinded
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent(s) or guardian(s) willing and able to provide consent prior to initiation of any study procedures
- •Stated willingness of parent(s) or guardian(s) to comply with all study procedures and availability for the duration of the study
- •Malaria comprehension exam completed by parent(s) or guardian(s) and passed with a score of ≥80% or per investigator's discretion
- •Healthy children 6-10 years of age at enrollment (inclusive)
- •Parent(s) or guardian(s) are able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- •Willing to have blood samples stored for future research
排除标准
- •Medical, behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant's parent and/or legal guardian to understand and comply with the study protocol
- •Menstruating females (in order to avoid cultural implications of further assessing pregnancy potential i.e. sexual activity in this age group)
- •Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratory-defined limits of normal and ≥ Grade 2 (subjects may be included at the investigator's discretion for 'not clinically significant' abnormal values)
- •Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal and ≥ Grade 2 (subjects may be included at the investigator's discretion for 'not clinically significant' abnormal values)
- •Infected with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- •Sickle cell disease by history
- •Taking or planning to take seasonal malaria chemoprophylaxis
- •Clinically significant abnormal electrocardiogram (ECG) such as abnormal QTc
- •History of receipt of the following:
- •Investigational malaria vaccine in the last 2 years
- •Immunoglobulins and/or blood products within 6 months of enrollment
- •Investigational product within 3 months of enrollment
- •Chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone ≥20 mg/day or equivalent) or immunosuppressive drugs within 30 days of enrollment
- •Live vaccine within 30 days of enrollment
- •Killed vaccine within 14 days of enrollment or planned receipt of a killed vaccine within 14 days of scheduled vaccination
- •Known medical problems:
- •Pre-existing autoimmune or antibody-mediated diseases (e.g. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia)
- •Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years)
- •Immunodeficiency disorder
- •Asplenia or functional asplenia
- •Deep venous thrombosis or thromboembolic event
- •Seizures (exception is simple febrile seizures during childhood)
- •Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies
结局指标
主要结局
Number of Participants With Possibly, Probably, or Definitely Related Serious Adverse Events (SAEs)
时间窗: From day of first vaccination until 26 weeks after 3rd vaccination (study day 1 to day 211)
Proportion of vaccinees compared to controls experiencing related SAEs from V1 to 26 weeks after V3
次要结局
未报告次要终点