ISRCTN31763161终止1 期
Safety and Immunogenicity of a Shigella tetravalent bioconjugate vaccine in adults
immaTech Biologics AG0 个研究点目标入组 40 人开始时间: 2023年9月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
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 informed consent for participation in the trial.
- •2. Male or Female, aged 18-55 years inclusive at time of vaccination.
- •3. In good health as determined by medical history, physical examination and clinical judgment of the study team.
- •4. Female participants of childbearing potential must be willing to ensure that they use highly effective contraception during the trial
- •5. In the Investigator’s opinion, is able and willing to comply with all trial requirements.
- •6. Able to attend the scheduled visits and to comply with all study procedures, including internet access for the recording of diaries
- •7. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS).
- •8. Agree to allow study staff to access the participant's NHS health records, vaccination records and medical history as required for study purposes and to allow his or her GP (and/or Consultant if appropriate), to be notified of participation in the study.
- •9. Agree to refrain from donating blood for the duration of the study.
排除标准
- •1. History of significant organ/system disease that could interfere with the trial conduct or completion in the clinical judgement of the investigators. 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. 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 disease including coagulation problems
- •1.9. Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency
- •1.10. Psychiatric illness requiring hospitalisation
- •1.11. Depression, anxiety or other psychiatric illness whose severity is deemed clinically significant by the study investigators
- •1.12. Known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week)
- •1.13. Non-benign cancer, except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ
- •2. Have any known or suspected impairment or alteration of immune function, resulting from, for example:
- •2.1. Congenital or acquired immunodeficiency (including IgA deficiency)
- •2.2. Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition
- •2.3. Autoimmune disease
- •2.4. 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).
- •3. Study 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
- •4. Have participated in previous Shigella species vaccination study
- •5. Receipt of a live or live attenuated vaccine within 4 weeks prior to vaccination or inactivated vaccine within 7 days prior to vaccination, or receipt of any vaccine other than the study vaccine within 4 weeks after any study vaccination.
- •6. Any history of allergy or anaphylaxis to a previous vaccine or vaccine component
- •7. Receipt of immunoglobulin or any blood product transfusion within 3 months of study start
- •8. Participation in another research study involving an investigational product or that which may compromise the integrity of the study (e.g. significant volumes of blood already taken in previous study) in the past 12 weeks, or are planning to do so within the trial period
- •9. Planned donation of blood/blood products outside of the study and during the trial period.
- •10. Inability, in the opinion of the Investigator, to comply with all study requirements including likelihood of successful venepuncture during the trial
- •11. Female participants who are pregnant, breastfeeding/lactating or planning pregnancy during the course of the study
- •12. Weight less than 50kg or a BMI < 1
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