ISRCTN97679658进行中（未招募）1 期
A Phase I, first-in-human safety and immunogenicity study of a Marburg virus vaccine, ChAdOx1 Marburg, in healthy volunteers aged 18–55 years in the UK
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 66
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
- 性别
- All
入选标准
- •1. Adults aged between 18 to 55 years (inclusive) at the time of screening.
- •2. Medically healthy, such that according to the investigator's judgement, hospitalisation within the study period is not anticipated, and the participant appears likely to be able to remain a study participant through the end of protocol-specified follow-up. Planned elective procedures for pre-existing conditions are allowable.
- •3. Able to attend the scheduled visits and comply with all study procedures, including internet access for the recording of electronic diary cards.
- •4. Willing and able to give informed consent for participation in the study.
- •5. Willing to allow confirmation of past medical and vaccination history either through provision of or access to a medical record summary or other medical documentation or allowing investigators to obtain a copy of their medical history from their GP practice or via electronic patient records.
- •6. Willing to allow their GP and/or consultant, if appropriate, to be notified of participation in the study.
- •7. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS).
- •8. Agreement to refrain from blood donation during the study.
- •9. For participants of childbearing potential only: willing to use effective contraception for the duration of the study AND to have a pregnancy test on the days of screening and vaccinations. The pregnancy tests taken prior to vaccinations must be negative.
排除标准
- •1. Participation in another research study, in which an investigational product has been administered or other procedures performed which could compromise the integrity of this study (such as significant volumes of blood taken) within the 12 weeks prior to enrolment or are planning to do so within the trial period.
- •2. History of previous confirmed or suspected Marburg virus infection.
- •3. Administration of immunoglobulins and/or any blood products within three months preceding the planned administration of the vaccine candidate.
- •4. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; severe infection(s); receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 12 months, or long-term systemic corticosteroid therapy (including for more than 7 consecutive days within three months preceding the planned administration of the vaccine candidate).
- •5. History of anaphylaxis in relation to vaccination.
- •6. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including hypersensitivity to the active substance or to any of the excipients of the IMP.
- •7. History of hereditary angioedema, acquired angioedema, or idiopathic angioedema.
- •8. History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- •9. History of any serious psychiatric condition likely to affect participation in the study.
- •10. Participants who are pregnant, breastfeeding or lactating, or are planning pregnancy during the course of the study.
- •11. History of a bleeding disorder (e.g. clotting factor deficiency, acquired coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.
- •12. History of confirmed major thrombotic event (including cerebral venous sinus thrombosis, deep vein thrombosis, pulmonary embolism); history of antiphospholipid syndrome, or history of heparin-induced thrombocytopenia.
- •13. History of capillary leak syndrome.
- •14. History of Guillain-Barre syndrome, transverse myelitis or other neuroinflammatory syndrome
- •15. Moderate, severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, haematological, immunological, endocrine disorder, or neurological illness (note, mild well-controlled co-morbidities in a healthy participant are acceptable as judged by the Investigator)
- •16. Suspected or known current alcohol abuse as per investigator’s discretion.
- •17. Suspected or known injecting drug use within the 5 years preceding enrolment.
- •18. Acute or chronic hepatitis B or hepatitis C infection.
- •19. HIV infection.
- •20. Any clinically significant finding on screening that is either unlikely to resolve or does not resolve (for example on repeat testing at the discretion of an Investigator) within the recruitment timeline of the study.
- •21. Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer if included in the study, affect the ability of the volunteer to participate in the study, or impair interpretation of the study data.
- •22. Member of the study team. This may include: anyone on the delegation log; anyone who might be anticipated to be placed onto the delegation log in the course of the study; anyone who has access to personal data on study participants (beyond name, contact details, DOB); and anyone who
研究者
相似试验
已完成
1 期
Study to evaluate safety and possible adverse reactions, especially serious, with a vaccine for measles and rubella in healthy subjects.Measles and RubellaRBR-9hckj4Bio-Manguinhos/Fiocruz/MS
已完成
不适用
First-in-human phase I safety, pharmacokinetic, and pharmacodynamic study of G1T28-1 in healthy male and female subjects.chemotherapy10027656CancerNL-OMON42109G1 Therapeutics58
尚未招募
1 期
A Vaccine for preventing PregnancyCTRI/2017/09/009934Indian Council of Medical Research
招募中
1 期
A phase I trial to assess safety and immunogenicity of an HLAII-targeted DNA vaccine against influenza H7N9Influenza prophylaxisCTIS2022-500706-18-01Oslo University Hospital Hf30
招募中
不适用
A Phase I trial to assess safety and immunogenicity of i.d. DNA priming and i.m. MVA boosting in healthy volunteers in MozambiqueHIV/AIDSPACTR201106000304583Swedish Institute for Infectious Disease Control24