CTRI/2021/11/038168已完成1 期
A prospective, open label, dose escalation phase I clinical study to evaluate the safety, tolerability and immunogenicity of Reliance Life Sciencesâ?? SARS-CoV-2 Recombinant protein subunit vaccine in healthy volunteers - R001
Reliance Life Sciences Pvt Ltd RLS0 个研究点目标入组 72 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
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
入选标准
- •1. Male and female healthy volunteers in age group 18-45 years (both inclusive),
- •2. The subjects voluntarily agreed to participate in the study, and signed an informed consent form, willing to comply with protocol requirements.
- •3. Healthy status as determined by the investigator based on history, clinical laboratory results, vital sign measurements, and on medical physical examination at screening.
- •4. Body temperature is between 95.6 to 99.0 ºF.
- •5. Body mass index (BMI) at 18.5 to 30.0 kg/m2 (inclusive).
- •6. Male and Female subjects of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication.
- •Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential.
- •Note-Female patients of child bearing potential must agree to use adequate contraception during the study and continue at least six months after the last dose of study drug. For this study, acceptable and effective methods of contraception for females include:
- •-Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period,
- •-Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or
- •-Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).
- •For males, adequate birth control methods suggested and defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam.
排除标准
- •The following criteria should be checked at the time of study entry. If any of these apply at the time of study entry, the subject must not be included in the study:
- •1. History of any of the following:
- •Any investigational vaccine or a COVID vaccine that has got emergency use
- •authorization or
- •Any product (investigational or off-label) for prevention of COVID-19 disease
- •Inoculated with any subunit vaccine and inactivated vaccine within 14 days
- •before the first dose of study vaccination,
- •Inoculated live attenuated vaccine within 30 days.
- •Received influenza vaccination within 14 days prior to first study vaccination
- •2. Have an acute or chronic illness, as determined by the site Principal Investigator (PI) or
- •sub-investigator, within 72 hours prior to study vaccination.
- •3. Seropositive for HIV 1 and 2, HBsAg and HCV
- •4. Have a history of severe allergies to any component of the research vaccine i.e. RLS
- •Protein Subunit Vaccine against SARS-CoV-2 Virus, including aluminum preparations,
- •such as: anaphylactic shock, allergic laryngeal edema, allergic purpura,
- •thrombocytopenic purpura, local allergic necrosis (Arthus reaction); or any previous
- •History of serious side effects of vaccines or drugs, such as allergies, urticaria, skin
- •eczema, dyspnea, angioedema, etc . History of allergic disease or reactions likely to be
- •exacerbated by any component of the vaccines in study.
- •5. Those with a history of SARS COVID-19 or current COVID-19 infection meeting any of
- •the following:
- •ï?? History of confirmed SARS-CoV 2 infection or symptomatic disease,
- •ï?? RTPCR test which is positive within 72 hours prior to enrollment.
- •ï?? Positive for SARS-CoV-2 IgG antibodies >= 5 (Index value).
- •6. Have taken antipyretics or analgesics within 24 hours before the first dose of vaccine.
- •7. Suspected or known current alcohol abuse as defined by an alcohol intake of greater
- •than 42 units every week for at least one year;
- •8. Chronic administration (defined as more than 14 days in total) of immunosuppressant
- •(e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying
- •drugs (e.g. interferons) during the period starting six months prior to the first vaccine
- •dose including use of any blood products. For corticosteroids, this will mean prednisone
- •> 0.5 mg/kg/day, or its equivalent (Methylprednisolone 0.4 mg/kg/day, Betamethasone0.08 mg/kg/day, Dexamethasone 0.08 mg/kg/day). Inhaled and topical steroids are allowed; Subjects under immune suppression post-transplant.
- •9. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
- •medical history and physical examination (no laboratory testing required);
- •10. Any medical condition that in the judgment of the investigator would make study
- •participation unsafe and/or can interfere with assessment or vaccine response.
- •11. Have received blood or blood-related products, including immunoglobulin within 3
- •months; or plan to use it during the study.
- •12. Lactating women or pregnant women (as determined by serum beta HCG).
研究者
相似试验
尚未招募
1 期
Phase 1 Study of D3S-001 as Monotherapy in Subjects with Advanced Solid Tumors with a KRAS p.G12C MutatioJPRN-jRCT2031220703Kanemitsu Jun10
招募中
不适用
A Phase 1, Open-label, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Subjects with Advanced Solid TumorsAdvanced solid tumors: subjects withclear-cell renal cell carcinoma (referred to as RCC expansion cohort) and subjects with first-lineStage IIIB or IV nonsquamous non-small cell lung cancer (NSCLCreferred to as NSCLC expansion cohort). = renal cell carcinoma and nonsquamous non-small cell lung cancer10027656NL-OMON54211MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC10
进行中（未招募）
1 期
A study to test if different doses of D3S-001 used on its own are safe and tolerable in people with advanced solid tumors with KRAS p.G12C modificatioCTIS2023-508517-16-00D3 Bio (Wuxi) Co. Ltd.165
已完成
不适用
A phase I, open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of GSK3326595 in subjects with solid tumors and non-Hodgkin*s lymphoma.solid tumors, non-hodgkin's lymphomasolid tumors and non-Hodgkins lymphomaNL-OMON53127GlaxoSmithKline39
尚未招募
不适用
A Phase 1, Open-label, Dose-escalation and Expansion Study of MEDI1191 Administered Intratumorally as Monotherapy and in Combination with Durvalumab in Subjects with Advanced Solid Tumors. Sub-study title: CD8+ Imaging Sub-study ProtocolcancerNL-OMON52188MedImmune, LLC, a wholly owned subsidiary of AstraZeneca PLC14