ISRCTN51750695
Completed
Phase 1
A Phase I clinical study to determine the safety and immunogenicity of a novel GMMA vaccine against invasive non-typhoid salmonella
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Oxford
- Enrollment
- 31
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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