A Phase Ib Randomised, Controlled, Single-blind Study to Assess the Safety, Immunogenicity of the Malaria Vaccine Candidate R21 With Matrix-M1 Adjuvant in West African Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of Administration of R21/Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.
研究概览
简要总结
This is a study in which healthy adult volunteers will be given either an experimental Malaria vaccine or a saline control vaccine.
Each volunteer will receive three vaccinations in total. Volunteers will be randomly allocated to one of two groups:
Group 1 will receive a low dose of the Malaria vaccine on days 0, 28, and 56. Group 2 will receive a saline solution on days 0, 28, and 56.
详细描述
A randomised, controlled, single-blind clinical trial to evaluate the safety and immunogenicity of the malaria vaccine candidate regime of three (3) doses of R21/Matrix-M1 compared with placebo, in healthy West African adult volunteers living in a malaria-endemic area.
The study will take place at the Centre National de Recherche et de Formation sur la Paludisme (CNRFP)/Unite de Recherche Clinique de Banfora (URC-B). Trial participants will be drawn from the Banfora Health Demographic system, which covers a total population of 30, 000.
Community sensitisation will be undertaken to engage the community with the study and recruit volunteers for participation in the study. The CNRFP study team will hold local community meetings and explain the study to the potentially eligible adult volunteers. During these meetings the investigators will explain the following: the need for a vaccine; the current status of vaccine development (including the fact that this is likely to be a prolonged process); the study screening and informed consent procedure; risks of vaccination and the unproven benefits of vaccination. It will be stressed that these are experimental vaccine regimens and cannot be guaranteed to provide protection, and that it will therefore still be necessary to seek treatment for possible malaria even after vaccination and they should continue to use other protective measures such as bed nets. It will be explained that to aid identification, a photograph of the volunteer will be taken if they are eligible to be enrolled in the trial.
After this meeting, based on the list of adults of suitable age for participation in the trial drawn from the DSS database, volunteers will be asked to participate in a public lottery that is made to randomly select participants who will be invited for a screening visit. All proposed volunteers thus selected will be invited to the Banfora clinical trials centre for the screening visit.
The Volunteer Information Sheet (VIS) will contain detailed information about the study and will be distributed to the proposed volunteers. The investigators will endeavour to ensure that all volunteers fully understand the risks. Any volunteer who appears to have less than complete understanding will be considered unable to give consent. If unable to sign, the volunteer will be asked to thumbprint the consent form in the presence of an impartial witness who will be present during the screening procedures and will countersign the consent form. Fully consented volunteers will undergo the full screening procedures. This consists of medical history, physical examination, and blood sampling for screening tests.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The volunteer must satisfy all the following criteria to be eligible for the study:
- •Healthy adults ages 18 to 45 years.
- •Willingness to remain in study area for the period of the study.
- •Able and willing (in the Investigator's opinion) to comply with all study requirements.
- •Women only: Must practice and show documented evidence of continuous effective contraception (e.g. depo-progesterone) or must be willing to take contraceptive measures not to become pregnant for the duration of the study. Willing to have pregnancy tests at screening and vaccination time points.
- •Agreement to refrain from blood donation during the course of the study.
- •Written informed consent to participate in the trial.
排除标准
- •The volunteer may not enter the study if any of the following apply:
- •Hb less than 10.0g/dl
- •Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
- •Prior receipt of an investigational malaria vaccine or any other investigational vaccine likely to impact on interpretation of the trial data.
- •Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic (more than 14 days) immunosuppressant or other immune-modifying drugs medication (for corticosteroids, this will mean prednisolone, or equivalent, ≥ 0.5mg/kg/day) within the past 6 months (inhaled and topical steroids are allowed).
- •Use of immunoglobulins or blood products within 3 months prior to enrolment.
- •History of allergic disease or hypersensitivity reactions likely to be exacerbated by any component of the study vaccines.
- •Any history of anaphylaxis post-vaccination.
- •History of clinically significant contact dermititis.
- •Pregnancy, lactation or intention to become pregnant during the study.
- •Disturbances of electrolyte balance, e.g. hypokalaemia or hypomagnesaemia.
- •History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- •History of serious psychiatric condition that may affect participation in the study.
- •History of splenectomy.
- •Any other serious chronic illness requiring hospital specialist supervision.
- •HIV or Hepatitis B surface antigen seropositivity.
- •Volunteers unable to be closely followed for social, geographic or psychological reasons.
- •Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of abnormal test results, confirmatory repeat test will be requested.
- •Any other significant disease, disorder, or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.
结局指标
主要结局
Safety and Tolerability of Administration of R21/Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.
时间窗: Assessment of solicited AEs in the first 7 days post vaccination.
Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.
时间窗: Unsolicited AEs to be assessed up to 28 days post vaccination.
Occurrence of unsolicited local and systemic adverse events. This will be done by recording the number of participants who experience unsolicited adverse events.
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.
时间窗: 6 months
Occurrence of serious adverse events will be collected from enrolment until the end of the follow-up period.
Safety and Tolerability of R21/Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events.
时间窗: At Day 0 (baseline), day 7 and day 28 post vaccination.
Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.
次要结局
未报告次要终点