EUCTR2020-005997-82-NL进行中（未招募）1 期
Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study(ACT-study) - ACT-Study
MCG0 个研究点目标入组 176 人开始时间: 2021年2月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 176
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Age 18-65 years (extremes included), males and females. This will be expanded to 85 years of age for phase II.
- •-SARS-CoV-2 serology (an anti-SARS-Cov-2 SP-specific IgG ELISA):
- •oTests negative for IgG titer and no known prior SARS-Cov-2 infection
- •-Body mass index (BMI) between 19.0 and 30.0 kg/m2, inclusive
- •-General good health, without significant medical illness, as determined via physical exam findings, ECG or vital signs
- •oNote: one retest of vital functions and ECG is allowed within the screening window
- •-No clinically significant laboratory abnormalities as determined by the investigator
- •oNote: one retest of lab tests is allowed within the screening window
- •-Informed Consent Form signed voluntarily before any study-related procedure is performed, indicating that the subject understands the purpose and procedures required for the study and is willing to participate in the study
- •-Willing to adhere to the prohibitions and restrictions specified in this protocol
- •-For phase I: nNo invitation is received to get a registered vaccine within the first 2 months after the moment of participation in this study. For phase II this criterium will be abandoned as the whole population will have received an invitation to get a registered vaccine. Therefore, a participant should agree not to receive a registered vaccine within 28 days after receiving the last AKS-452 vaccine.
- •-Negative hepatitis panel (including hepatitis B surface Ag and anti-hepatitis C virus Abs) and negative human immunodeficiency virus Ab and Ag screens at screening
- •-Female subjects should fulfil one of the following criteria:
- •oAt least 1 year post-menopausal (amenorrhea >12 months and/or follicle-stimulating hormone >30 mIU/mL) at screening;
- •oSurgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
- •oWill use adequate forms of contraceptives from screening to discharge.
- •-Female subjects of childbearing potential and male subjects who are sexually active with a female partner of childbearing potential must agree to the use of an effective method of birth control from screening to discharge
- •oNote: medically acceptable methods of contraception that may be used by the subject and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, double barrier, sterilization and vasectomy
- •-Female subject has a negative pregnancy test at screening and upon check-in at the clinical site.
- •oNote: pregnancy testing will consist of a serum pregnancy test at screening and urine pregnancy tests at other (dosing) visits, in all women.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 176
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 176
排除标准
- •- Pregnant of breast feeding females
- •- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, hematologic,
- •rheumatologic, endocrine, autoimmune, or renal disease
- •- Any laboratory test which is abnormal, and which is deemed by the Investigator(s) to be
- •clinically significant
- •- Behavioral or cognitive impairment or psychiatric disease that in the opinion of the
- •investigator affects the ability of the subject to understand and cooperate with the study
- •- Current alcohol/illicit drug/nicotine abuse or addiction: history or evidence of current drug
- •use or addiction (positive drug screen for amphetamines, barbiturates, benzodiazepines,
- •cannabinoids, cocaine, or opiates) or signs of excessive use of alcohol at screening and Day -2.
- •- Presence of any febrile illness (T > = 38.0°C or lab confirmed viral disease (PCR)) or
- •symptoms suggestive of a viral respiratory infection within 1 weeks prior to vaccination
- •- Use of corticosteroids (excluding topical preparations for cutaneous or nasal use) or use
- •of immunosuppressive drugs within 30 days before inoculation
- •- A history of anaphylaxis, history of allergic reaction to vaccine, known allergy to one of the
- •components in AKS-452. Mild allergies without angio-oedema or treatment need can be
- •included if deemed not to be of clinical significance (including but not limited to allergy to
- •animals or mild seasonal hay fever)
- •- A history of asthma within the past 10 years, or a current diagnosis of asthma or reactive
- •airway disease associated with exercise
- •- Receipt of a licensed vaccine within 4 weeks prior to viral inoculation
- •- Received any experimental SARS-CoV-2 vaccine or drug
- •- Receipt of blood or blood-derived products (including immunoglobulin) within 6 months
- •prior to vaccination.
- •- Receipt of another investigational agent within 30 days or 5 times the product half-life
- •(whichever is longest) prior to vaccination
- •- Shares household with /works with immunocompromised individual(s), adults with
- •significant cardiopulmonary disease, persons with significant asthma, institutionalized
- •elderly or elderly with functional disability
- •- Deprived of freedom by an administrative or court order or in an emergency setting
- •- Any condition that in the opinion of the principal investigator (PI) would jeopardize the
- •safety or rights of a person participating in the trial or would render the person unable to
- •comply with the protocol.
研究者
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