Phase IIb Immunogenicity, Efficacy and Safety Study of P. Falciparum Vaccine Candidate, MSP3-LSP Adjuvanted in Aluminium Hydroxide Versus Verorab Control in Healthy Children Aged 12-48 Months in Mali.
试验速览
- 阶段
- 2 期
- 入组人数
- 378
- 试验地点
- 2
- 主要终点
- Number of clinical malaria episodes occurring during the consecutive malaria transmission season after the third vaccination
研究概览
简要总结
This study will be the fourth time that the candidate malaria vaccine Merozoite Surface Protein - long synthetic chain, will be tested in malaria endemic populations.in the past,once tested in adults and twice in children proved to be safe in all three occasions for this phase IIb study in children to proceed. This study will include children who will be randomly allocated to either receive the malaria vaccine adjuvanted with Aluminium Hydroxide or the Verorab control. Each participant will receive 3 immunizations, without the clinical investigators or the participants themselves knowing what has been given. They will then be followed-up for immediate reactions to vaccination, extended safety profile and immunological response associated with protection from malaria. These children will be followed up for over a longer term of two years. Blood will be taken to evaluate the biological safety parameters and also the immune responses.
详细描述
This will be a double blind, randomized, placebo-controlled phase IIb study to evaluate the immunogenicity, efficacy and safety of Plasmodium falciparum vaccine candidate, Merozoite Surface Protein-3 Long synthetic peptide (MSP3) adjuvanted in aluminium hydroxide versus Verorab control in healthy children aged 12-48 months in Mali
A phase Ib trial is currently ongoing in Burkina Faso as well as in Tanzania and its interim results inform on the best dose/adjuvant combination to be safely extended in younger children. The trial is evaluating immunogenicity,efficacy and safety of 3 doses of 30 µg MSP3 adjuvanted in aluminium hydroxide
Primary objective:
- To assess the efficacy of MSP3-LSP:
- Determine the efficacy of MSP3-LSP in children aged 12-48 months against all clinical malaria episodes (Axillary temperature of ≥ 37.5ºC with P. falciparum parasitemia) occurring during the consecutive malaria transmission season after the third vaccination (six months after the third vaccination).
Secondary Objectives:
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)
入排标准
- 年龄范围
- 12 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 12-48 months old
- •Healthy by medical history, physical examination and laboratory investigation
- •Signed/thumb printed informed Consent by guardian/parent
- •Resident in the study area villages during the whole trial period
排除标准
- •Symptoms, physical signs of disease that could interfere with the interpretation of the trial results or compromising the health of the subjects
- •Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (Inhaled and topical steroids are allowed).
- •Cannot be followed for any social, psychological or geographical reasons.
- •Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
- •Suspected or known hypersensitivity to any of the vaccine components or to previous vaccine.
- •Laboratory abnormalities on screened blood samples.
- •Planned administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. An exception, is the receipt of an EPI or licensed vaccine (measles, oral polio, Hib, meningococcal and combined diphtheria/pertussis/tetanus vaccines) which may be given 14 days or more before or after vaccination
- •Evidence of chronic or active hepatitis B or C infection
- •Presence of chronic illness that, in the judgment of the investigator, would interfere with the study outcomes or pose a threat to the participant's health.
- •Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
- •History of surgical splenectomy.
- •Moderate or severe malnutrition at screening defined as weight for age Z-score less than 2
结局指标
主要结局
Number of clinical malaria episodes occurring during the consecutive malaria transmission season after the third vaccination
时间窗: 27 Months
次要结局
- Solicited adverse events measured from day 0 to day 7 after each dose(7 days)
- Unsolicited adverse events measured up to one month after each dose(Day 84)
- Serious Adverse Events measured during the 12 months of study duration(2 years)
- The humoral response to the vaccine antigen: assessed by measuring the level of IgG by ELISA(Day 84)
- IgG ability to recognize the native protein on Merozoite using Western Blot(WB) method(Day 84)
- Incidence of all clinical malaria episodes occurring through two transmission seasons subsequent to the 3 doses.(2 years)