NCT05142514已完成2 期
A Phase IIb Study to Evaluate Safety and Immunogenicity of Recombinant Protein RBD Fusion Dimer Candidate Vaccine Against the Virus That Cause COVID-19, Known as Severe Acute Respiratoy Syndrome Coronavirus 2 (SARS-CoV-2) in Adult Healthy Volunteers
Hipra Scientific, S.L.U1 个研究点 分布在 1 个国家目标入组 629 人开始时间: 2021年11月11日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 629
- 试验地点
- 1
- 主要终点
- Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
研究概览
简要总结
This is a Phase IIb, randomized, controlled, observer-blinded, clinical trial to evaluate safety and immunogenicity of COVID-19 Vaccine HIPRA in adult healthy volunteers in Vietnam
详细描述
The study population includes 256 healthy adults aged 18-60 which will be randomized in a ratio 1:1 test:commercial vaccine. Each participant will receive 2 immunisations separated by 21 days and will be followed for 24 weeks after the second dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults males or females between 18-60 years of age at the day of screening.
- •Willing and able to comply with scheduled visits, laboratory test, complete diaries and other study procedures.
- •Body Mass Index 18 to 40 Kg/m2 at screening.
- •COVID19 negative quick test or PCR test and negative serum IgG binding antibody response to the SARS-CoV-2 S glycoprotein at screening or prior the first vaccination. If an enrolled subject has neutralizing antibodies at baseline, he or she will be excluded from final analysis.
- •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.
- •Women of childbearing potential must have a negative pregnancy test in urine before the inclusion of the study and prior to each vaccination.
- •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.
- •If male and not sterilized, willing to avoid impregnating female partners from screening until 8 weeks after last injection.
- •Willing and able to provide written informed consent prior the initiation of any study procedures.
排除标准
- •Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study.
- •Positive pregnancy test at screening or prior to each vaccination.
- •Any medical disease (acute, subacute, intermittent or chronic) or condition with grade 2 or above that in the opinion of the investigator compromise the volunteer's safety, preclude vaccination or compromise interpretation of the results.
- •History of serious psychiatric condition likely to affect participation in the study.
- •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.
- •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.
- •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).
- •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.
- •Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections.
- •Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital).
- •Acute illness within 72 hours prior each vaccination that in the opinion of the investigator may interfere the evaluation of safety parameters.
- •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.
- •History of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticarial, angioedema and other significant reactions related to food, drugs, vaccines or pharmaceutical agents.
- •History of allergic disease or reactions likely to be exacerbated by any component of the COVID-19 vaccine HIPRA
- •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.
- •Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination.
- •Known disturbance of coagulation (iatrogenic or congenital) or blood dyscrasias.
- •Known bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
- •Chronic liver disease
- •Positive test for HIV types 1 or 2 infection, hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV Abs) at screening
- •Suspected or known current alcohol abuse or any other substances abuse (except tobacco).
- •History of COVID-19 infection.
- •Receipt of medications intended to prevent COVID-
- •Ever received an experimental vaccine against COVID-
- •Close contact of anyone known to have SARS-CoV-2 infection within 15 days prior to screening visit.
- •Being directly involved in the conduct of the study
- •Any condition and/or laboratory finding that at the investigator consideration would interfere with the study or put at risk the participant.
结局指标
主要结局
Safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers
时间窗: 30 weeks
Number and percentage of serious adverse events throughout the study duration.
次要结局
- Immunogenicity(Day 21 and 35.)
- Immunogenicity to the SARS-CoV-2 spike glycoprotein(Day 21 and 35.)
- Immunogenicity to the SARS-CoV-2 spike glycoprotein at long-term(24 weeks after the second dose)
- Immunogenicity at long-term(24 weeks after the second dose)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) VaccineSeasonal InfluenzaNCT01072799Novavax4,560
已完成
2 期
Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine.Polio and Post-Polio SyndromeNCT03902054Jiangsu Province Centers for Disease Control and Prevention600
已完成
2 期
Study on the Safety and Immunogenicity of Boostrix Vaccine in Pregnant Malian Women and Their InfantsClostridium Difficile ImmunisationDiphtheria ImmunisationTetanus ImmunisationPertussisTetanusDiphtheriaNCT03589768National Institute of Allergy and Infectious Diseases (NIAID)399
招募中
1 期
A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.Malaria,FalciparumNCT05790889University of Oxford480
撤回
2 期
Safety and Immunogenicity of EV71 Vaccine With or Without Aluminum Adjuvant in InfantsInfection, Viral, EnterovirusNCT01812135Sinovac Biotech Co., Ltd