Topic: Infection
Conditions
Interventions
The first five volunteers will receive 1x10(10) vp the subsequent fifteen volunteers will receive 7.5x10(10) vp. Doses will be administered at a single time point to healthy volunteers.
Sponsors
York Hospital HNS Trust (UK)
University of York
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 50 years on the day of screening 2. Available for the duration of the study 3. Willing and able to give written informed consent 4. In good health as determined by medical history, physical examination, results of screening tests and the clinical judgment of a medically qualified Clinical Investigator 5. Judged, in the opinion of a medically qualified Clinical Investigator, to be able and likely to comply with all study requirements as set out in the protocol 6. Willing to undergo screening for HIV, Hepatitis B and Hepatitis C 7. Agree to refrain from blood donation for the duration of the study 8. Have been registered with a GP for at least the past 3 months and willing to allow a clinical investigator to discuss the volunteer?s medical history with their GP 9. For females only, using a reliable method of contraception (methods defined as one of; combined oral contraceptive pill, desogestrel-containing progesterone only pill (Cerazette), intra-uterine contraceptive device or system, injectable contraceptive or progesterone implant) from 14 days prior to the vaccination until 90 days after vaccination 10. For females only, willing to undergo urinary pregnancy tests on the day of screening, on the day of vaccination (prior to vaccination) and 28 and 90 days after vaccination 11. For males only, willing to use barrier contraception (male condoms) with every act of sexual intercourse until 28 days after the vaccination. The clinical site will provide condoms. 12. Agree to registration on a national database of trial volunteers to prevent over-volunteering (TOPS) which includes the taking of a photograph to be kept at the trial site
Exclusion criteria
Exclusion criteria: 1. Prior receipt of a recombinant adenoviral-vectored vaccine 2. Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned enrolment during the study period 3. Receipt of a live attenuated vaccine within 60 days or other vaccine within 14 days of screening 4. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate 5. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or a history of severe or multiple allergies to drugs or pharmaceutical agents 6. History of clinically significant contact dermatitis 7. Any history of severe local or general reaction to vaccination as defined as: 7.1. Local : extensive, indurated redness and swelling involving most of the antero-lateral thigh or the major circumference of the arm, not resolving within 72 hours 7.2. General : fever = 39.5°C within 48 hours, anaphylaxis, bronchospasm, laryngeal oedema, collapse, convulsions or encephalopathy within 48 hours 8. Females ? pregnancy, less than 12 weeks postpartum, lactating or willingness/intention to become pregnant during the study and for 3 months following vaccination 9. Seropositive for hepatitis B surface antigen (HBsAg) or Hepatitis C (antibodies to HCV) 10. Any history of Leishmaniasis or positive antibody response on the InBios leishmania strip test 11. Significant concern raised by GP in relation to participation 12. Any clinically significant abnormal finding on screening biochemistry or haematology blood tests or urinalysis 13. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (only mild to moderate topical steroids as listed in the BNF are allowed) 14. Any other significant disease, disorder or finding, which, in the opinion of a medically qualified Clinical Investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer?s ability to participate in the study 15. Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent 16. Unlikely to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and reactogenicity, actively and passively collected data on adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: markers of humoral and cell-mediated immunity | — |
Countries
United Kingdom
Outcome results
None listed