Prevention of plague caused by the intracellular bacterium Yersinia pestis Infections and Infestations
Conditions
Interventions
The study is a phase Ib, non-blinded, non-randomised study to assess the safety and immunogenicity of one or two doses at different prime-boost intervals of the recombinant adenovirus plague vaccine c
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 49 Years
Inclusion 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 8. Clinically acceptable baseline screening results (includes vital signs, physical examination, urinalysis, and laboratory results) 9. In the Investigator’s opinion, is able and willing to comply with all trial requirements
Exclusion criteria
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) 2.9. Metabolic diseases such as glucose-6-phosphate dehydrogenase deficiency 2.10. Psychiatric illness requiring hospitalisation or depression if the severity is deemed clinically significant by the Study Investigators 2.11. Known or suspected drug and/or alcohol misuse 2.12. Non-benign cancer, except squamous cell or basal cell carcinoma of the skin and cervical carcinoma in situ 3 Any other significant disease or disorder which, in the opinion of the Investigator, could: 3.1. Put the participant at risk because of participation in the trial 3.2. Influence the result of the trial 3.3. Impair the participant’s ability to participate in the trial 4. History of allergy to a vaccine or any component of the vaccines used in this study 5. History of anaphylaxis 6. Have any known or suspected impairment or alteration of immune function, resulting from, for example: 6.1. Congenital or acquired immunodeficiency 6.2. Human Immunodeficiency Virus infection or symptoms/signs suggestive of an HIV-associated condition 6.3. Autoimmune disease 6.4. 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) 7. Receipt of immunoglobulins or any blood product transfusion within 3 months prior to enrolment 8. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial 9. Weight <50kg or a body mass index (BMI)greater than 35kg/m2 10. Previous occurrence of disease caused by Y pestis receipt of a vaccine against plague 11. Current active participation in another research study involving an investigational product (including receipt of an IMP within last 30 days) or where involvement in this study could impact the results 12. It is not in the best interest of the volunteer to participate in the trial, in the opinion of the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local, systemic, and laboratory adverse events were recorded using ediaries, participant reporting to the study team, and routine laboratory haematology and biochemistry tests: 1. Local and systemic solicited adverse events from Day 0 to Day 7 post-vaccination 2. Unsolicited adverse events recorded for 28 days following each vaccination 3. Laboratory adverse events (safety blood tests) on Day 7 and day 28 following each vaccination 4. Serious adverse events (SAEs) collected throughout the study period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Antibody responses to the vaccine antigens as measured by ELISA on Day 28 post each vaccination 2. Immune responses to vaccines measured by immunological assays potentially including: 2.1. Antibody concentration against vaccine antigens before and after vaccination 2.2. Antibody functional capacity in vitro assays (serum bactericidal, phagocytosis, invasion) 2.3. Antibody functional capacity in vivo challenge assay (by serum transfer) in blood samples from visits Day 0 to Day 210 inclusive | — |
Countries
Uganda
Contacts
Public ContactDenis Murphy
Outcome results
None listed