ISRCTN79243381
Active, Not Recruiting
Phase 1
A phase Ib study to assess the safety and immunogenicity of a recombinant adenovirus-based vaccine against plague in Uganda (PlaVac Uganda)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of plague caused by the intracellular bacterium Yersinia pestis
- Sponsor
- niversity of Oxford
- Enrollment
- 36
- Status
- Active, Not Recruiting
- Last Updated
- 3 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 trial
- •2\. Male or female aged between 18\-49 years old inclusive at enrolment (first vaccination visit)
- •3\. In good health as determined by:
- •3\.1\. Medical history (as determined by verbal medical history)
- •3\.2\. Physical examination
- •3\.3\. Clinical judgment of the investigators
- •4\. Female participants of childbearing potential must be willing to ensure that they use effective contraception during the trial and for 3 months after the last vaccination
- •5\. Female participants of childbearing potential must have a negative pregnancy test on the day(s) of screening and vaccination
- •6\. Able to attend the scheduled visits and comply with all study procedures
- •7\. Agrees to refrain from donating blood for the duration of the trial
Exclusion Criteria
- •1\. Pregnancy, lactating or planning pregnancy during the course of the trial
- •2 History of significant organ/system disease that could interfere with trial conduct or completion, including known history of significant disease in the following:
- •2\.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
- •2\.2\. Respiratory diseases such as uncontrolled asthma and chronic obstructive pulmonary disease
- •2\.3\. Endocrine disorders such as diabetes mellitus and Addison’s disease
- •2\.4\. Significant renal or bladder disease
- •2\.5\. Biliary tract disease
- •2\.6\. Gastro\-intestinal diseases such as inflammatory bowel disease, major abdominal surgery within the last two years, coeliac disease and liver disease (including hepatitis B or C infection)
- •2\.7\. Neurological diseases such as seizures and myasthenia gravis
- •2\.8\. Haematological problems such as coagulation problems or anaemia (haemoglobin \< 12\.5g/dl for females and \< 13\.5 g/dl and for males)
Outcomes
Primary Outcomes
Not specified
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