NL-OMON51213已完成2 期
Anti-COVID19 AKS-452 Phase I/II VaccinaTion Study (ACT-Study) - ACT-Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 112
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age 18-85 years (extremes included), males and females
- •- SARS-CoV-2 serology (an anti-SARS-Cov-2 SP-specific IgG ELISA):
- •o Tests 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
- •o Note: one retest of vital functions and ECG is allowed within the screening
- •- No clinically significant laboratory abnormalities as determined by the
- •investigator
- •o Note: 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
- •- For phase I: No 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. For the booster study with
- •the naked AKS-452 (non-adjuvanted), the participants should waive
- •their right to receive a registered vaccine within the first 56 days after
- •receiving the booster 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
- •- Female subjects should fulfil one of the following criteria:
- •o At least 1 year post-menopausal (amenorrhea >12 months and/or
- •follicle-stimulating hormone >30 mIU/mL) at screening;
- •o Surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation);
- •o Will 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
- •o Note: 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.
- •o Note: pregnancy testing will consist of a serum pregnancy test at screening
- •and urine pregnancy tests at other (dosing) visits, in all women.
排除标准
- •- Pregnant or 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 protocol
- •- 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-edema
- •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
- •- 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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