Safety Study of ChAdOx1 85A Vaccination With and Without MVA85A Boost in Healthy Adults
Phase I Trial to Evaluate the Safety and Immunogenicity of a ChAdOx1 85A Vaccination With and Without MVA85A Boost in Healthy BCG Vaccinated Adults
1 other identifier
interventional
42
1 country
2
Brief Summary
This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A vaccination with and without MVA85A boost in healthy BCG vaccinated adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jul 2013
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2013
CompletedFirst Posted
Study publicly available on registry
April 11, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 12, 2016
May 1, 2016
2.8 years
March 26, 2013
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of ChAdOx1 85A vaccination with, and without, MVA85A boost vaccination in healthy, BCG vaccinated adults.
To evaluate the safety in healthy BCG-vaccinated subjects of ChAdOx1 85A vaccination, with and without MVA85A boost vaccination, by actively and passively collecting data on adverse events.
Six months following vaccination
Secondary Outcomes (1)
To investigate the T-cell immune response of ChAdOx1 85A vaccination compared with ChAdOx1 85A vaccination with MVA85A boost vaccination.
Six months following vaccination
Other Outcomes (1)
To conduct further exploratory immunological analyses on samples from vaccinees in this trial.
Six months following vaccination
Study Arms (4)
Starter Group
EXPERIMENTALThe first six volunteers will receive one dose of 5x10\^9vp of ChAdOx1 85A intramuscular injection.
Group A
EXPERIMENTAL12 subjects will receive one dose of 2.5x10\^10vp of ChAdOx1 85A intramuscular injection.
Group B
EXPERIMENTAL12 subjects will receive one dose of 2.5x10\^10vp of ChAdOx1 85A by intramuscular injection, followed by a boost dose of 1x10\^8pfu of MVA85A by intramuscular injection 56 days later.
Group C
EXPERIMENTAL12 subjects will receive two doses of 2.5x10\^10vp of ChAdOx1 85A by intramuscular injection at day 0 and day 28, followed by a boost dose of 1x10\^8pfu of MVA85A by intramuscular injection at day 119.
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must meet all of the following criteria to enter the trial:
- Healthy adult aged 18-55 years
- Resident in or near Oxford (for CCVTM) or Birmingham (for WTCRF) and able to travel to Oxford for vaccinations for the duration of the trial period
- No relevant findings in medical history or on physical examination
- Confirmation of prior vaccination with BCG not less than 6 months prior to projected trial vaccination date (by visible BCG scar on examination or written documentation)
- Allow the Investigators to discuss the individual's medical history with their GP
- Use effective contraception for the duration of the trial period (females only)
- Refrain from blood donation during the trial
- Give written informed consent
- Allow the Investigator to register subject details with a confidential database to prevent concurrent entry into clinical trials
- Able and willing (in the Investigator's opinion) to comply with all the trial requirements
You may not qualify if:
- Subjects must meet none of the following criteria to enter the trial:
- Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISpot response to ESAT6 or CFP10 antigens
- Clinical, radiological, or laboratory evidence of current active TB disease
- Shared a residence within one year prior to day 0 with an individual on anti-tuberculosis treatment or with culture- or smear-positive pulmonary tuberculosis
- Previous vaccination with any recombinant MVA, FP or adenoviral vector
- Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
- History of serious psychiatric condition
- Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
- History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine including eggs
- Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the subject in the trial
- Positive HBsAg, HCV or HIV antibodies
- Female currently lactating, confirmed pregnancy or intention to become pregnant during trial period
- Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device for 30 days prior to dosing with the trial vaccine, or planned use during the trial period
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
- Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the subject at risk or may influence the result of the trial or may affect the subject's ability to participate in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- University of Birminghamcollaborator
Study Sites (2)
Centre for Clinical Vaccinology and Tropical Medicine , University of Oxford
Oxford, Oxfordshire, OX3 7LE, United Kingdom
The NIHR/ Wellcome Trust Clinical Research Facility, University of Birmingham
Birmingham, West Midlands, B15 2TB, United Kingdom
Related Publications (1)
Crisan-Dabija R, Grigorescu C, Pavel CA, Artene B, Popa IV, Cernomaz A, Burlacu A. Tuberculosis and COVID-19: Lessons from the Past Viral Outbreaks and Possible Future Outcomes. Can Respir J. 2020 Sep 5;2020:1401053. doi: 10.1155/2020/1401053. eCollection 2020.
PMID: 32934758DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen McShane
University of Oxford
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2013
First Posted
April 11, 2013
Study Start
July 1, 2013
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
May 12, 2016
Record last verified: 2016-05