Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Aeras
Crucell Holland BV
Emergent BioSolutions
University of Birmingham
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01683773
First received: August 24, 2012
Last updated: February 11, 2014
Last verified: October 2013
  Purpose

This trial will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other. The trial will assess the safety of both vaccines and also their ability to stimulate an immune response within the body. It is hoped that when these two vaccines are given in sequence, the combined immune response is even better than when each vaccine is used individually.


Condition Intervention Phase
Tuberculosis
Biological: AERAS-402
Biological: MVA85A
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I, Open Label Trial to Evaluate the Safety and Immunogenicity of AERAS-402 Followed by MVA85A in BCG Vaccinated Adults (TB032)

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Safety of AERAS-402 followed by MVA85A [ Time Frame: 3 months after final vaccination ] [ Designated as safety issue: Yes ]
    To evaluate the safety profile of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults, measured by number and severity of local and systemic adverse events


Secondary Outcome Measures:
  • Immunogenicity of AERAS-402 followed by MVA85A [ Time Frame: 12-18 months after first vaccination ] [ Designated as safety issue: No ]
    To evaluate and compare the immune responses as described by flow cytometric intracellular cytokine staining, antibody serology, and Elispot assays of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults


Enrollment: 40
Study Start Date: September 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Two doses of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection)
Biological: AERAS-402
Intramuscular needle injection 1x10^11 vp
Other Name: Ad35 TB-S
Biological: MVA85A
Intradermal needle injection 1x10^8 pfu
Other Name: AERAS-485
Experimental: Group B
One dose of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection)
Biological: AERAS-402
Intramuscular needle injection 1x10^11 vp
Other Name: Ad35 TB-S
Biological: MVA85A
Intradermal needle injection 1x10^8 pfu
Other Name: AERAS-485
Experimental: Group C
Three doses of AERAS-402 (1x10^11 vp intramuscular injection)
Biological: AERAS-402
Intramuscular needle injection 1x10^11 vp
Other Name: Ad35 TB-S

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683773

Locations
United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital
Oxford, Oxfordshire, United Kingdom, OX3 7LE
The Wellcome Trust Clinical Research Facility (WTCRF), University of Birmingham
Birmingham, West Midlands, United Kingdom, B15 2TH
Sponsors and Collaborators
University of Oxford
Aeras
Crucell Holland BV
Emergent BioSolutions
University of Birmingham
Investigators
Principal Investigator: Helen McShane University of Oxford
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01683773     History of Changes
Other Study ID Numbers: TB032
Study First Received: August 24, 2012
Last Updated: February 11, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
Tuberculosis
Phase I
MVA85A
AERAS-402

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

ClinicalTrials.gov processed this record on July 28, 2014