ACTRN12619001022156已完成1 期
A Phase I Study of the Safety and Immunogenicity of ACT-1239, a Vaccine for Plasmodium falciparum Malaria
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Healthy males and females aged between 18-45 years (inclusive)
- •Body mass index (BMI) 18-32 kg/m2 (inclusive);
- •Negative test for selected drugs of abuse at screening (does not include alcohol) and prior to enrollment on Day 1;
- •Non-pregnant and non-lactating females, and either surgically sterile for a minimum of 6 months, or use highly effective contraceptive method (oral contraceptives pills, long-acting implantable hormones, injectable hormones, a vaginal ring or an intrauterine device [IUD]) from screening until at least 3 months after the last vaccination with ACT-1239, or be post-menopausal for greater then or equal to 12 months. Post-menopausal status will be confirmed through testing of follicle-stimulating hormone (FSH) levels (greater than or equal to 40 IU/mL) at screening for amenorrhoeic female participants. Females who are abstinent from heterosexual intercourse will also be eligible;
- •Women of child-bearing potential (WOCBP) must have a negative pregnancy test at screening and on Day 1 prior to enrollment and be willing to have additional pregnancy tests as required throughout the study;
- •Surgically sterile males, or if engaged in sexual relations with a WOCBP, the participant and his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or using an acceptable, highly effective contraceptive method from screening for at least 3 months after the last vaccination with ACT-1239. Acceptable methods of contraception include the use of condoms and the use of an effective contraceptive for the female partner (WOCBP) that includes: OCPs, long acting implantable hormones, injectable hormones, a vaginal ring or an IUD. Male participants whose female partner is post-menopausal, and participants who are abstinent from heterosexual intercourse will also be eligible. Male participants must agree to refrain from donating sperm from screening for at least 3 months after the last vaccination with ACT-1239;
- •No plans to travel to a malaria endemic area over the study duration
排除标准
- •Pregnant or lactating females at screening or plans to become pregnant or breastfeed from the time of enrollment until 3 months after the last vaccination;
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, rheumatologic, psychiatric, or neurologic disorders (including seizure disorder and chronic migraine headaches);
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases;
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational vaccine administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the participant inappropriate for entry into this study;
- •History of severe allergy (requiring hospital care), severe reaction to any drug or prior vaccination, or any known or suspected allergies or sensitivities to any component of the investigational vaccine;
- •Immunosuppression caused by disease;
- •History of autoimmune disorder;
- •Seropositive for HIV or Hepatitis C Virus or Hepatitis B surface antigen (HBsAg) positive;
- •History of splenectomy or of condition affecting splenic function;
- •Significant infection or other acute illness, including fever over 37.5°C on the day of enrollment;
- •Birthmarks, tattoos, wound or other skin conditions over the deltoid region of both arms that, in the Investigator’s opinion, could reasonably obscure and interfere with evaluation of local injection site reactions;
- •Thrombocytopenia or bleeding disorder contraindicating IM vaccination;
- •Inadequate venous access to allow collection of blood samples;
- •Receipt of immunoglobulins or blood products within 3 months of first vaccination or any planned administration during the study period;
- •Use of immunosuppressive or other immune-modifying drugs within six months of vaccination and for the study duration (inhaled and topical steroids are permitted);
- •Use of prescription or non-prescription drugs, and herbal supplements within 14 days or 5 half-lives (whichever is the longer) prior to the first vaccination. As an exception, ibuprofen (preferred) may be used at doses of up to 800 mg/day, or paracetamol at doses up to 4 g/day may be used for minor ailments during the course of the study, at the Investigator’s discretion, without prior consultation with the Sponsor’s MM. Paracetamol and ibuprofen may be used for treatment of AEs occurring after vaccination, but should not be administered prophylactically for such events, as such use may mask reactogenicity and interfere with immune responses. Limited use of other non-prescription medications or vitamins not believed to affect participant safety, or the overall results of the study may be permitted on a case-by-case basis following approval by the Sponsor in consultation with the Investigator;
- •Receipt of any licensed vaccine within 30 days prior to first vaccination or before the 6 month follow up visit (6 months following last administered vaccination);
- •Use of any investigational or non-registered drug or vaccine within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study vaccine or planned use during the study period;
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