PACTR202108616900606尚未招募3 期
Phase 3 Study of Immunogenicity and Safety of Adjuvanted SARS-CoV-2 (SCB 2019) Vaccine in Healthy Adults and Individuals with HIV Infection
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 600
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
- •1.Male or female =18 years of age.
- •2.Individuals or their witnesses in case of illiteracy are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, and other study procedures.
- •3.Individuals are willing and able to give an informed consent, prior to screening.
- •4.Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception using a highly effective licensed method of birth control for 30 days prior to the first vaccination and has a negative pregnancy test on the day of vaccination and must agree to continue such precautions during until 90 days after the last vaccination.
- •5.Male participants must agree to employ acceptable contraception from the day of first dose of the study vaccine/comparator until 6 months after the first dose of the study vaccine/comparator and refrain from donating sperm during this period.
- •6.For HIV infected participants: individuals should be in general good health except stable HIV infection receiving a stable ART treatment for at least 6 months (defined as no change because of virological or immunological failure) and to have a CD4+ T-cell count > 200 cells/mm3 and a HIV RNA load of =50 copies/mL at screening.
排除标准
- •1.Individuals with fever >37.5°C (irrespective of method), or any acute illness at baseline (Day 1) or within 3 days prior to randomization. Participants meeting this criterion may be rescheduled within the relevant window. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.
- •2.Individuals with laboratory-confirmed SARS-CoV-2 infection (as defined by Rapid COVID Antigen Test or an equivalent at Visit 1) or with history of COVID-19.
- •3.Individuals who have received a prior investigational or authorized or licensed COVID-19 vaccine.
- •4.Any confirmed or suspected immunosuppressive or immunodeficient condition except HIV infection resulting from disease or immunosuppressive/cytotoxic therapy (e.g., medications used for cancer chemotherapy, organ transplantation or to treat autoimmune disorders) within 6 months prior to enrollment.
- •5.Individuals who have a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix which have been cured, or other malignancies with minimal risk of recurrence).
- •6.Individuals with any progressive unstable or uncontrolled clinical conditions.
- •7.Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last study vaccination.
- •8.Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccines (CpG/Alum/SCB-2019 components as outlined in the latest IB).
- •9.Individuals who have received any other investigational product within 30 days prior to Day 1 or intend to participate in another clinical study at any time during the conduct of this study.
- •10.Individuals who have received any other authorized or licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 21 days after the last vaccination.
- •11.Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection.
- •12.Individuals who have received treatment with rituximab or any other anti-CD20 monoclonal antibodies within 9 months prior to enrollment or planned during the study period.
- •13.Individuals who have received intravenous immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the study period.
- •14.Individuals with any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional participant risk.
研究者
相似试验
进行中（未招募）
不适用
Safety and efficay of 3 new low dose polio vaccines with adjuvant compared to a full dose polio vaccine without adjuvantProfylactic immunisation against poliomyelitisMedDRA version: 17.0Level: LLTClassification code 10054187Term: Polio immunizationSystem Organ Class: 100000004865EUCTR2014-000052-29-DKStatens Serum Institut
进行中（未招募）
1 期
A Study of Nivolumab in Combination with Ipilimumab Compared toNivolumab Alone in Treatment of Patients After Complete Resection ofStage IIIb/c/d or Stage IV Melanoma.Stage IIIb/c/d or Stage IV no evidence of disease (NED) melanomafollowing complete resection of the lesion(s) with high risk of relapse.MedDRA version: 21.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10040891Term: Skin melanomaSystem Organ Class: 100000004864EUCTR2016-003729-41-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO1,844
进行中（未招募）
1 期
A Study of Nivolumab in Combination with Ipilimumab Compared to Nivolumab or Ipilimumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.Stage IIIb/c/d or Stage IV no evidence of disease (NED) melanoma following complete resection of the lesion(s) with high risk of relapse.MedDRA version: 19.1Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864MedDRA version: 19.1Level: LLTClassification code 10040891Term: Skin melanomaSystem Organ Class: 100000004864EUCTR2016-003729-41-ESBristol-Myers Squibb International Corporation1,125
进行中（未招募）
1 期
A Study of Nivolumab in Combination with Ipilimumab Compared to Nivolumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.EUCTR2016-003729-41-GBBristol-Myers Squibb International Corporation2,560
进行中（未招募）
1 期
A Study of Nivolumab in Combination with Ipilimumab Compared to Nivolumab Alone in Treatment of Patients After Complete Resection of Stage IIIb/c/d or Stage IV Melanoma.Stage IIIb/c/d or Stage IV no evidence of disease (NED) melanoma following complete resection of the lesion(s) with high risk of relapse.MedDRA version: 20.0Level: LLTClassification code 10053571Term: MelanomaSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10040891Term: Skin melanomaSystem Organ Class: 100000004864EUCTR2016-003729-41-BEBristol-Myers Squibb International Corporation2,560