ISRCTN51750695已完成1 期
A Phase I clinical study to determine the safety and immunogenicity of a novel GMMA vaccine against invasive non-typhoid salmonella
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
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 study
- •2. Aged between 18 and 55 years inclusive
- •3. In good health as determined by:
- •3.1. Medical history
- •3.2. Physical examination
- •3.3. Clinical judgment of the investigators
- •4. (Females) Willing to use effective contraception (such as the oral contraceptive pill, contraceptive implant or barrier methods) from 1 month prior to receiving the first vaccine and for the duration of the study
- •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 and/or Consultant, if appropriate, to be notified of participation in the study
- •7. Willing to allow the study team access to medical records for the purposes of eligibility assessment and/or safety follow up during the trial.
- •8. Willing to provide their national insurance number or passport number to be registered on The Over-Volunteering Prevention System (TOPS)
排除标准
- •Current exclusion criteria as of 14/09/2022:
- •The participant may not enter the study if any of the following apply:
- •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:
- •1.2. 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
- •1.3. Respiratory disease such as uncontrolled asthma and chronic obstructive pulmonary disease
- •1.4. Endocrine disorders such as diabetes mellitus and Addison’s disease
- •1.5. Significant renal or bladder disease
- •1.6. Biliary tract disease
- •1.7. 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)
- •1.8. Neurological disease such as seizures and myasthenia gravis
- •1.9. Haematological disease including coagulation problems
- •1.10. Metabolic disease such as glucose-6-phosphate dehydrogenase deficiency
- •1.11. Psychiatric illness requiring hospitalisation
- •1.12. Depression, anxiety or other psychiatric illness whose severity is deemed clinically significant by the study investigators
- •1.13. Known or suspected drug and/or alcohol misuse (alcohol misuse defined as an intake exceeding 42 units per week)
- •1.14. 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 received any oral typhoid vaccination (e.g. Ty21a or M01ZH09) within the last 3 years or a paratyphoid vaccine (as part of a clinical trial)
- •5. Have participated in previous typhoid or paratyphoid challenge studies (with ingestion of challenge agent).
- •6. Receipt of a live vaccine within 4 weeks prior to vaccination or a killed vaccine within 7 days prior to vaccination
- •7. Plan to receive any vaccine other than the study vaccine within 4 weeks after any study vaccination (COVID-19 vaccine exempt, see Section 9.14)
- •8. Any history of allergy or anaphylaxis to a pre
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