Malaria Infection Diagnosed by PCR as a Means of Evaluating Pre-erythrocytic Candidate Malaria Vaccines
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Suitability and acceptability of study method
研究概览
简要总结
The ability to test candidate pre-erythrocytic stage malaria vaccines, using a well-established sporozoite challenge model, in a field setting with group sizes of tens rather than hundreds of volunteers would greatly facilitate identification of the most promising vaccine candidates. The investigators assessed the suitability and acceptability of this method in a field trial in semi-immune volunteers exposed to natural infection during the high malaria transmission season.
详细描述
Objective
The primary objective of the study was to determine if the very sensitive PCR technique, capable of detecting malaria parasites at low densities could be used as an economical method of undertaking preliminary field evaluation of pre-erythrocytic malaria vaccines. A secondary objective was to determine if the intensive blood sampling that this method requires would be acceptable.
Study area
This study was conducted from June to October 2004 when the incidence of malaria in The Gambia is highest. Volunteers were recruited from 9 villages east of Farafenni, a town which is 200km east of the capital city, Banjul. Malaria is highly seasonal in this area with an entomological inoculation rate between 10 and 50 infectious bites per year.
Study population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single
入排标准
- 年龄范围
- 15 Years 至 45 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged 15-45 years
- •Signed informed consent form
排除标准
- •Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease or neurological illness.
- •Any clinical evidence of immunosuppression such as oral candida, stomatitis, aphthous or septic ulceration, septic skin lesions or any clinical or laboratory evidence of infection or immunosuppression.
- •History of splenectomy
- •Haematocrit of less than 30%
- •Serum creatinine concentration >130mmol/L
- •Serum ALT concentration >80 IU/L
- •Blood transfusion within one month of the beginning of the study
- •History of vaccination with a previous experimental malaria vaccine
- •Administration of any other vaccine or immunoglobulin within two weeks of scheduled vaccination.
- •Positive HIV antibody test.
- •Positive colorimetric test for G-6-P-D deficiency.
- •Current participation in another clinical trial, or within 12 weeks of this study.
- •Lack of parental consent if volunteer is aged under 18
- •Likelihood of travel away from the study area for the duration of the study
- •Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial
- •Known allergy to sulfadoxine/pyrimethamine (SP), Artesunate or Lapdap
- •Drug or alcohol addiction
- •Egg allergy
结局指标
主要结局
Suitability and acceptability of study method
次要结局
- Prevention of malaria parasitaemia
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine