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

Tuberculosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01829490
• Other study ID #: TB034
• Status: Active, not recruiting
• Phase: Phase 1
• First received: March 26, 2013
• Last updated: January 27, 2016
• Start date: July 2013
• Est. completion date: April 2016

Study information

• Verified date: January 2016
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tuberculosis

Intervention

Biological:
• ChAdOx1 85A
Intramuscular injection
• MVA85A
Intramuscular injection

Locations

Country	Name	City	State
United Kingdom	The NIHR/ Wellcome Trust Clinical Research Facility, University of Birmingham	Birmingham	West Midlands
United Kingdom	Centre for Clinical Vaccinology and Tropical Medicine , University of Oxford	Oxford	Oxfordshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	To conduct further exploratory immunological analyses on samples from vaccinees in this trial.		Six months following vaccination	No
Primary	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	Yes
Secondary	To investigate the T-cell immune response of ChAdOx1 85A vaccination compared with ChAdOx1 85A vaccination with MVA85A boost 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.	Six months following vaccination	No

External Links

•   Jenner Institute Clinical Trials