ISRCTN41077863进行中（未招募）1 期
A phase I study to assess the safety and immunogenicity of a recombinant adenovirus-based vaccine against plague
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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. Willing and able to give written informed consent for participation in the study
- •2. Aged between 18 and 55 years inclusive at the time of first visit
- •3. In good health as determined by medical history (as determined by verbal medical history), physical examination, clinical judgment of the investigators.
- •4. Female participants (of childbearing potential) who are willing to ensure that they or their partner use effective contraception during the vaccination period and for the months after vaccination and have a negative pregnancy test on the day(s) of screening and vaccination
- •5. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diary cards
- •6. Willing to allow his or her General Practitioner (GP) to be notified of participation
- •7. Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner or hospital consultant and access all medical records, including electronic patient records, when relevant to study procedures
- •8. Agrees to refrain from donating blood for the duration of the trial
- •9. Agrees to be registered on the Trial Over-Volunteering Prevention Service (TOPS) and agree to provide their National Insurance number or passport number (if not a British citizen) for the purposes of registration
- •10. Agrees to provide National Insurance number and bank details for reimbursement purposes
- •11. Normal baseline/screening laboratory (blood/urine) results
排除标准
- •1. History of significant organ/system disease that could interfere with trial conduct or completion. This includes any history of significant disease in the following:
- •1.1. Cardiovascular disease including congenital heart disease, previous myocardial infarction, valvular heart disease (or history of rheumatic fever), previous bacterial endocarditis, history of cardiac surgery (including pacemaker insertion), personal or family history of cardiomyopathy or sudden adult death
- •1.2. Respiratory disease such as uncontrolled asthma and chronic obstructive pulmonary disease
- •1.3. Endocrine disorders such as diabetes mellitus and Addison’s disease
- •1.4. Significant renal or bladder disease
- •1.5. Biliary tract disease
- •1.6. Gastro-intestinal disease such as inflammatory bowel disease, abdominal surgery within the last two years, coeliac disease and liver disease (including hepatitis B or C infection)
- •1.7. Neurological disease such as seizures and myasthenia gravis
- •1.8. Haematological problems such as coagulation problems or anaemia (haemoglobin < 125g/L and < 135 g/L for females and males, respectively)
- •1.9. Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency
- •1.10. Psychiatric illness requiring hospitalisation or depression if severity is deemed clinically significant by the study Investigators
- •1.11. Known or suspected drug and/or alcohol misuse (defined as an intake exceeding 42 units per week)
- •1.12. Non-benign cancer, except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ
- •2. History of allergy or anaphylaxis to a vaccine or any component within the vaccines used in this study
- •3. Have any known or suspected impairment or alteration of immune function, resulting from, for example:
- •3.1. Congenital or acquired immunodeficiency
- •3.2. Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
- •3.3. Autoimmune disease
- •3.4. 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 days consecutively within the previous 3 months).
- •4. Any significant abnormalities on screening investigations that are either unlikely to resolve or do not resolve on repeat testing (at the discretion of an Investigator) within the recruitment timeline of the study
- •5. Weight <50 kg
- •6. Donation of blood within the last 3 (male) or 4 (female) months or plans on giving blood within the next year
- •7. Receipt of a live vaccine within 4 weeks prior to vaccination
- •8. Plan to receive any vaccine other than the study vaccine within 2 weeks following vaccination
- •9. Scheduled procedures requiring general anaesthesia during the study
- •10. Receipt of immunoglobulin or any blood product transfusion within 3 months of study start
- •11. Current active participation in another research study involving an investigational product or where involvement in this study could impact the results
- •12. Previous occurrence of disease caused by Y. pestis or vaccine against plague
- •13. Inability, in the opinion of the Investigator, to comply with all study requirements
- •14. Female participants who are pregnant, lactating or who are unwilling to ensure that they or their partner use effective contraception throughout the trial period
- •15. Participant unwilling to allow contact with their GP or is not registered with a GP
- •16. Any other significant disease or disorder which, in the opini
研究者
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