PACTR202112597608463尚未招募1 期
A Phase I/II Study to Evaluate the Safety, Reactogenicity and Immunogenicity of RBD SARS-CoV-2 HBsAg VLP Vaccine in Healthy Adults.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female aged above 18 years (inclusive)
- •Phase I: Participants aged 18 to 45 years (both inclusive)
- •Phase II: Participants aged above 18 years (inclusive) (Strata 1: 18 to 59 years (both inclusive), Strata 2: above 60 years (inclusive).
- •Healthy participants as determined by medical history, physical examination, vital signs and clinical and laboratory examination.
- •Test negative for SARS-CoV-2 infection by RT-PCR test at screening
- •Test negative for -SARS-CoV-2 IgG antibody by serology test at screening
- •Capable and willing to provide written informed consent prior to the performance of any study-specific procedures.
排除标准
- •Receipt of medications or vaccines intended to prevent or treat COVID-19 infection in the past.
- •Fever (non-axillary temperature > 37.5 ºC) or any other symptoms of infection that have not completely resolved including respiratory symptoms/illnesses within the past 3 days from randomization (Day 0)
- •Participants with a BMI > 35 kg/m2.
- •A major or clinically significant medical condition.
- •Individuals currently working in occupations with high risk of exposure to SARS-CoV
- •Pregnant or lactating women or willingness/intention to become pregnant during the study.
- •History of allergy to any component of the RBD SARS-CoV-2 HBsAg VLP Vaccine, or serious adverse reactions to the vaccine
- •A history of anaphylaxis to a vaccine, food, drug, toxin or other exposure
- •Known hypersensitivity reactions to yeast.
- •Positive test result at screening for HIV ½ antibody, HBsAg or HCV Ab
- •Clinical laboratory tests of blood and urine not within the normal range and show clinically relevant deviations as judged by the Investigator.
- •History of demyelinating disease or Guillain Barre syndrome
- •Eczema or other significant skin lesion or infection at the site/s of vaccination
- •Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination
- •Positive screen for drugs of abuse or alcohol (breath test) at screening and randomization (Day 0).
- •(Drugs of abuse include amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, and tetrahydrocannabinol).
- •Participants who currently smoke at least 10 cigarettes or equivalent per day
- •Receipt of blood/blood products/immunoglobulins or donation of blood/blood products 8 weeks prior to vaccination or planned receipt or donation during the study period
- •Any other medical condition which in the opinion of the Investigator may affect the subject’s safety or study participation and conduct.
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