PACTR202407803870883尚未招募1 期
Phase I open-label, age de-escalation trial to assess safety, tolerability, and immunogenicity of the intramuscularly administered combination of RH5.1 and R78C malaria vaccine with Matrix-MTM adjuvant in healthy adults and infants in Tanzania.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
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
- 0 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •1. Healthy adults aged 18 to 45 years and infants aged 5-17 months
- •2. Adults and parents able and willing (in the Investigator's opinion) to comply with all study
- •requirements
- •3. Permanent residence or planned long term stay (at least 15 months) in the study area or
- •surroundings for the period of the trial.
- •4. Female participants are required to use an effective form of contraception during this
- •study. Acceptable forms of contraception include:
- •a. Established use of oral, injected or implanted hormonal methods of
- •contraception.
- •b. Placement of an intrauterine device or intrauterine system
- •c. Total abdominal hysterectomy
- •5. For adults: Written informed consent to receive malaria vaccine candidates
- •6. For infants: written informed consent to receive malaria vaccine candidates will be
- •obtained from the parent/guardian.
- •7. Reachable (24 hours and 7 days a week) by mobile phone during the entire study period
- •(From screening to last follow up visit)
- •8. Answer all questions on the informed consent quiz correctly in a maximum of three
排除标准
- •Any history, or evidence at screening, of clinically significant symptoms, physical signs or
- •abnormal laboratory values suggestive of systemic conditions, such as cardiovascular,
- •pulmonary, renal, hepatic, neurological, dermatological, endocrine, malignant,
- •haematological, infectious, immunodeficient, psychiatric and other disorders, which could
- •compromise the health of the participant during the study or interfere with the
- •interpretation of the study results.
- •2. Use of immunoglobulins or blood products within 3 months prior to enrolment
- •3. Previous vaccination with a Malaria vaccine.
- •4. Pregnancy (determined by positive urine pregnancy test), lactation, or intention to become
- •pregnant during the study.
- •5. Any other serious chronic illness requiring hospital specialist supervision
- •6. Volunteers unable to be closely followed for social, geographic, or psychological reasons
- •7. Positive for P. falciparum parasites by Blood smear at screening or previous participation
- •in any malaria vaccine study.
- •8. Any other condition or situation that would, in the opinion of the investigator, place the
- •participant at an unacceptable risk of injury or render the participant unable to meet the
- •requirements of the protocol.
- •9. Clinically significant congenital abnormalities as judged by the PI or other delegated
- •individual.
- •10. History of allergic disease or reactions likely to be exacerbated by any component of the
- •vaccines, e.g., Kathon, neomycin, beta-propiolactone
- •11. Any history of anaphylaxis in relation to vaccination.
- •12. Participation in another research study involving receipt of an investigational product in
- •the 30 days preceding enrolment, or planned use during the study period.
- •13. Scheduled elective surgery or other procedures requiring general anaesthesia during the
研究者
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