ACTRN12621000504819已完成未知
Older adult study to evaluate the safety, performance, usability, and acceptability of skin application of a placebo excipient coated HD-MAP technology intended for use in vaccinations.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 48
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
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Aged 50 years (inclusive), or older.
- •2.Subject has a Body Mass Index (BMI) within the range 18.0–34.9 kg/m².
- •3.Satisfactory medical assessment, with no clinically significant or relevant abnormalities in medical history, physical examination, and vital signs.
- •4.Females of childbearing potential and males should either be sexually inactive (abstinent) for 14 days prior to Day 0 and throughout the study or be using one of the following acceptable birth control methods:
- •i.Surgically sterile (hysterectomy and/or bilateral oophorectomy);
- •ii.Surgically sterile (bilateral tubal ligation with surgery at least 6 months prior to study initiation);
- •iii.IUD in place for at least 3 months;
- •iv.Stable hormonal contraceptive for at least 3 months prior to study through completion of study;
- •v.Surgical sterilization (vasectomy) for male participants or for female participant’s partner at least 6 months prior to study
- •vi.Condom for male participant together with effective contraception for their female partner.
- •5.Postmenopausal women must have had at least 12 months since their last menstrual period
- •6.Subject can communicate effectively with study personnel and is considered reliable, willing, and cooperative in terms of compliance with the protocol requirements.
- •7.Subject is able and willing to provide written, personally signed and dated informed consent to participate in the study.
排除标准
- •1.Subject with birthmarks, tattoos, wounds, scars, moles, blemishes, heavy hair or other skin conditions (such as eczema or sunburn) on forearms or upper arms (both arms) which could reasonably obscure potential application sites
- •2.Subject with known severe chronic spontaneous urticaria / dermographism
- •3.Subject with known allergy/sensitivity to ingredients of MAP (plastic) or coating (sugars), including gold
- •4.Previous adverse reaction to fluorescein or synthetic dyes, for example, after angiography or ophthalmic procedures.
- •5.Known predisposition to keloid scar formation
- •6.History of granulomatous diseases (especially sarcoidosis and granuloma annulare)
- •7.History of clinically significant gastrointestinal, hepatic, renal, cardiovascular, dermatological, immunological, respiratory, endocrine, oncological, neurological, metabolic, psychiatric disease, or haematological disorders
- •8.History of malignancy, other than in situ malignancy, basal cell carcinoma, or non-invasive squamous cell carcinoma of the skin.
- •9.An active medical condition (which is deemed as clinically significant) that is under evaluation or treatment, or a recent illness, a chronic illness, or an autoimmune disease
- •10.History of Hepatitis B, Hepatitis C, or HIV infection
- •11.History of abnormal bleeding tendencies unrelated to venepuncture or intravenous cannulation (e.g. haemophilia, thrombocytopenia).
- •12.Receiving chronic treatment with immune-suppressive therapy (asthma inhalers and topical corticosteroids are permitted). All medications will be documented and reviewed for acceptance by the Principal Investigator or a medically qualified nominee
- •13.History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study
- •14.Subject has donated blood or plasma or clinically significant blood loss within 14 days prior to screening visit
- •15.Subject has received blood or plasma within 60 days prior to screening visit
- •16.Subject is pregnant or breast-feeding
- •17.A history of alcohol or drug abuse in the last 12 months or current alcohol consumption is >4 standard drinks (or equivalent) per day
- •18.Use of any prescription medication (except for contraceptives) within 7 days, unless approved by the PI. All medications will be documented and reviewed for acceptance by the PI or a medically qualified nominee
- •19.Use of any investigational drug or device within 30 days or 5 half-lives of the drug, whichever is longer, prior to the Day 0
- •20.A Vaxxas employee, or relative of a Vaxxas employee.
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