A phase I study to assess the safety and immunogenicity of a recombinant adenovirus-based vaccine against plague

niversity of Oxford0 sites36 target enrollmentApril 20, 2021

Overview

No summary available.

Registry

who.int

Start Date

April 20, 2021

End Date

May 31, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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

•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