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Safety Study of ChAdOx1 85A Vaccination With and Without MVA85A Boost in Healthy Adults

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ClinicalTrials.gov Identifier: NCT01829490
Recruitment Status : Completed
First Posted : April 11, 2013
Last Update Posted : May 12, 2016
Sponsor:
Collaborator:
University of Birmingham
Information provided by (Responsible Party):
University of Oxford

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.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: ChAdOx1 85A Biological: MVA85A Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I Trial to Evaluate the Safety and Immunogenicity of a ChAdOx1 85A Vaccination With and Without MVA85A Boost in Healthy BCG Vaccinated Adults
Study Start Date : July 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Starter Group
The first six volunteers will receive one dose of 5x10^9vp of ChAdOx1 85A intramuscular injection.
Biological: ChAdOx1 85A
Intramuscular injection

Experimental: Group A
12 subjects will receive one dose of 2.5x10^10vp of ChAdOx1 85A intramuscular injection.
Biological: ChAdOx1 85A
Intramuscular injection

Experimental: Group B
12 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.
Biological: ChAdOx1 85A
Intramuscular injection

Biological: MVA85A
Intramuscular injection

Experimental: Group C
12 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.
Biological: ChAdOx1 85A
Intramuscular injection

Biological: MVA85A
Intramuscular injection




Primary Outcome Measures :
  1. Safety of ChAdOx1 85A vaccination with, and without, MVA85A boost vaccination in healthy, BCG vaccinated adults. [ Time Frame: Six months following vaccination ]
    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.


Secondary Outcome Measures :
  1. To investigate the T-cell immune response of ChAdOx1 85A vaccination compared with ChAdOx1 85A vaccination with MVA85A boost vaccination. [ Time Frame: Six months following vaccination ]
    To evaluate the systemic and mucosal cellular immunogenicity in healthy BCG-vaccinated subjects of ChAdOx1 85A vaccination, compared with ChAdOx1 85A vaccination with MVA85A boost vaccination, by comparing laboratory markers of cell mediated immunity in blood.


Other Outcome Measures:
  1. To conduct further exploratory immunological analyses on samples from vaccinees in this trial. [ Time Frame: Six months following vaccination ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829490


Locations
United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine , University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 7LE
The NIHR/ Wellcome Trust Clinical Research Facility, University of Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TB
Sponsors and Collaborators
University of Oxford
University of Birmingham
Investigators
Principal Investigator: Helen McShane University of Oxford

Additional Information:
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01829490     History of Changes
Other Study ID Numbers: TB034
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by University of Oxford:
Vaccine
Immunogenicity

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections