ISRCTN57717892已完成2 期
A randomized, open label, single centre, phase 2 trial of the malaria vaccine, R21/Matrix-M™, to assess safety and immunogenicity of the vaccine in Thai adults
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
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
- 性别
- All
入选标准
- •1. Participant is a healthy adult, aged 18 to 55 years (both inclusive), of Thai origin.
- •2. Participant is willing and able to voluntarily give informed consent to participate in the trial
- •3. Able, in the investigator’s opinion, and willing to comply with the study requirements and follow-up.
- •4. Women of childbearing potential: must agree to practice continuous, effective contraception for the duration of the trial, and have a negative pregnancy test before each vaccination. (Costs for contraceptives will be reimbursed by the trial.)
排除标准
- •1. Pregnancy or breastfeeding, or planned pregnancy during the course of the study.
- •2. Presence of any medical condition (physical or mental) which, may place the participant at undue risk or interfere with the results of the study*. Including: serious cardiac, renal, hepatic, or neurological disease, severe malnutrition
- •3. Any confirmed or suspected immunosuppressive or immunodeficient condition. Including: history of splenectomy, human immunodeficiency virus (HIV) infection
- •4. Chronic administration (>14 days in total) of immunosuppressants or other immune-modifying drugs within six months of enrollment. Including: oral corticosteroids equivalent to prednisone > 20 mg/day (a*)
- •5. History of an autoimmune disease
- •6. Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (b*) detected in serum.
- •7. HIV antibody detected in serum
- •8. Screening electrocardiogram (ECG) demonstrating a QTc interval = 450 ms
- •9. Finding on safety laboratory values as defined below:
- •9.1. AST > 2 x upper normal limit
- •9.2. ALT > 2 x upper normal limit
- •9.3. Anaemia (Hb < 10 g/dL),
- •9.4. Platelets < 150,000
- •9.5. Total bilirubin > 2 x upper normal limit
- •10. Abnormalities of examination or investigations at screening. Including: hepatomegaly, right upper quadrant abdominal pain or tenderness, abnormal blood tests (as defined in the protocol which are not listed above)
- •11. Positive malaria parasitaemia (RDT) at screening or baseline (Month 0, Day 0).
- •12. Receipt or planned receipt of an investigational medical product or participation in an interventional clinical trial during the study period
- •13. Contraindications to the use of artemisinins, piperaquine or primaquine*.
- •14. Use of medications with known potential interactions, prior allergic reactions to one or more components of the drug regimen.
- •15. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products)
- •16. History of clinically significant contact dermatitis.
- •17. Contraindication to intramuscular (IM) injection*
- •18. Administration of a vaccine not included in the study protocol within 7 days of a study vaccine (c*).
- •19. History of anaphylaxis post-vaccination.
- •20. Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
- •* subject to the investigator’s judgement
- •Exceptions:
- •(a*) Inhaled and topical steroids.
- •(b*) Participation in hepatitis C vaccine study with confirmed negative HCV antibodies prior to participation in that study, and negative HCV RNA PCR at screening for this study
- •(c*) The following vaccinations may be administered more than 7 days before or after a study vaccination: polio, diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, Bacillus Calmette–Guérin (BCG vaccine), measles, influenza, pneumococcal disease, COVID-19 or yellow fever
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