Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01683773
• Date of registration: 24/08/2012
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A
• Scientific title: A Phase I, Open Label Trial to Evaluate the Safety and Immunogenicity of AERAS-402 Followed by MVA85A in BCG Vaccinated Adults (TB032)
• Date of first enrolment: September 2012
• Target sample size: 40
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01683773
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Helen McShane
• Affiliation: University of Oxford

Key inclusion & exclusion 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

- Agrees to avoid elective surgery for the duration of the trial

- Has a body mass index (BMI) between 18 and 33 (weight/height2) by nomogram

- 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 treatment for active or latent tuberculosis infection

- Received a TST within 90 days prior to day 0

- Received a systemic antibiotic within 14 days prior to day 0

- Inability to discontinue daily medications other than the following during the trial:
oral contraceptives, vitamins, nonprescription nutritional supplements, aspirin,
antihistamines, antihypertensives, antidepressants, inhaled steroids,
bronchodilators, and any other stable, regular medication not deemed to have an
impact on safety or immunogenicity.

- Previous vaccination with candidate vaccine MVA85A or candidate vaccine FP85A or any
other recombinant MVA or adenoviral vaccine; AERAS-402; or any other investigational
M. tb vaccine

- Clinically significant history of skin disorder, allergy, immunodeficiency (including
HIV), autoimmune disease, 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 triala

- 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 other than the trial vaccine 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Biological: AERAS-402

Biological: MVA85A

Primary Outcome(s)

Safety of AERAS-402 followed by MVA85A [Time Frame: 3 months after final vaccination]

Secondary Outcome(s)

Immunogenicity of AERAS-402 followed by MVA85A [Time Frame: 12-18 months after first vaccination]

Secondary ID(s)

TB032

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Crucell Holland BV

Emergent BioSolutions

University of Birmingham

Aeras