PACTR201402000719423已完成未知
Safety and Immunogenicity of Recombinant Pichia Pastoris AMA1-DiCo Candidate Malaria Vaccine With GLA-SE and Alhydrogel ® as Adjuvant in Healthy Malaria Non-Exposed European and Malaria Exposed African Adults:a Staggered Phase Ia/Ib, Randomised, Double-blind, Multi-Centre Trial
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- INSERM
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Year(s) 至 45 Year(s)（—）
- 性别
- All
入选标准
- •1. Age > 20 and < 45 years healthy female and male
- •2. General good health based on history, physical and laboratory examination
- •3. Written informed consent obtained before any trial procedure
- •4. Available to participate in follow-up for the duration of trial.
- •5. For Female and male volunteers: practicing contraception before and up to four (4) weeks after the third vaccination.
- •Additionnal Inclusion criteria for malaria non-exposed European volunteers :
- •6. Reachable by phone during the whole trial period
- •7. Volunteers should be affiliated to a social security regimen
排除标准
- •1. Positive pregnancy test
- •2. Active breast feeding
- •3. Previously participated in any malaria vaccine trial
- •4. History of blood transfusion within the last 6 months
- •5. Symptoms, physical signs or laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the trial results or compromise the health of the volunteers.
- •6. Any clinically significant laboratory abnormalities on screened blood samples beyond the normal range, as defined at the clinical trial site.
- •7. Enrolment in any other clinical trial during the whole trial period
- •8. Intake of chronic medication, especially immunosuppressive agents (steroids, immunomodulating or immunosuppressive drugs) during the thirteen weeks preceding the screening visit or during the trial period except topical steroid use including intranasal.
- •9. Any confirmed or suspected immunosuppressive or immunodeficiency condition during the whole trial period
- •10. Volunteers unable to be closely followed for social, geographic or psychological reasons.
- •11. Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the trial.
- •12. History of anaphylaxis or Known severe hypersensitivity to any of the vaccine components (adjuvant or antigen or excipient).
- •13. Vaccination or gammaglobulin within 4 weeks prior and after each vaccination. If a vaccination is necessary during this period; the volunteer will be withdrawn from the study.
- •14. Positive HIV, HBV (Ag HBS) and HCV tests.
- •Additional Exclusion Criteria for malaria non exposed European volunteers:
- •15. History of malaria or travel in malaria endemic areas within the past twenty-six weeks.
- •16. Positive serology for malaria antigen PfAMA-1
- •17. Intention to travel to malaria endemic countries during the trial period.
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