EUCTR2021-001411-82-ES进行中（未招募）1 期
A phase I/IIa study to evaluate safety and immunogenicity of recombinant protein RBD fusion dimer candidate vaccine against SARS-CoV-2 in adult healthy volunteers.
ABORATORIOS HIPRA, S.A.0 个研究点目标入组 30 人开始时间: 2021年6月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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
- •1. Adults males or females between 18-39 years of age at the day of screening.
- •2. Willing and able to comply with scheduled visits, laboratory test, complete diaries and other study procedures.
- •3. Body Mass Index 18 to 40 Kg/m2 at screening.
- •4. COVID19 negative PCR test and negative serum IgG binding antibody response to the SARS-CoV-2 S glycoprotein at screening or prior the first vaccination.
- •5. Willing to avoid all other vaccines within 4 weeks before and after each injection. Seasonal influenza vaccination is allowed if it is received at least 14 days before or after the vaccination.
- •6. Women of childbearing potential must have a negative pregnancy test in urine before the inclusion of the study and prior to each vaccination.
- •7. If female of childbearing potential, willing to use highly effective contraceptive methods or have practiced sexual abstinence from the screening visit until 8 weeks after the last injection. Highly effective contraceptive methods will include: oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner and sexual abstinence.
- •8. If male and not sterilized, willing to avoid impregnating female partners from screening until 8 weeks after last injection.
- •9. Willing and able to provide written informed consent prior the initiation of any study procedures.
- •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 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study.
- •2. Positive pregnancy test at screening or prior to each vaccination.
- •3. Any medical disease (acute, subacute, intermittent or chronic) or condition that in the opinion of the investigator compromise the volunteer's safety, preclude vaccination or compromise interpretation of the results.
- •4. History of serious psychiatric condition likely to affect participation in the study (e-g- ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).
- •5. History of respiratory disease (e.g., chronic obstructive pulmonary disease (COPD) and asthma) requiring any daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years.
- •6. History of significant cardiovascular disease including hypertension (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.
- •7. History of neurological or neurodevelopmental conditions (e.g., migraines, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).
- •8. Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.
- •9. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections.
- •10. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital).
- •NOTE: Mild psoriasis, well controlled autoimmune thyroid disease, vitiligo, stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy and any stable endocrine disorders that have a confirmed autoimmune aetiology (e.g., thyroid, pancreatic), including stable diet-controlled diabetes will be permitted at the discretion of the investigator.
- •11. Acute illness within 72 hours prior each vaccination that in the opinion of the investigator may interfere the evaluation of safety parameters.
- •12. Usage of any investigational drug = 90 days prior to study entry or plan to participate in another research involving an investigational product (drug/biologic/device) within 12 months after the first study vaccination.
- •13. History of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticarial, angioedema and other significant reactions related to food, drugs, vaccines or pharmaceutical agents.
- •14. History of allergic disease or reactions likely to be exacerbated by any component of the COVID-19 vaccine HIPRA (including the oil in water adjuvant ).
- •15. Use of any immunosuppressant, glucocorticoids, or other immune-modifying drugs within 2 months prior to first study vaccination; or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination.
- •NOTE: The use of topical, inhaled, and nasal routes are not permitted.
- •16. Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination.
- •17. Known disturbance of coagulation (iatrogenic or congenital) or blood dyscrasias.
- •18. Known bleeding disorder
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