Safety Study of Tuberculosis Vaccines AERAS-402 and MVA85A

September 16, 2014 updated by: University of Oxford

A Phase I, Open Label Trial to Evaluate the Safety and Immunogenicity of AERAS-402 Followed by MVA85A in BCG Vaccinated Adults (TB032)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 7LE
        • Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • The Wellcome Trust Clinical Research Facility (WTCRF), University of Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Ad35 TB-S
Biological: MVA85A
Intradermal needle injection 1x10^8 pfu
Other Names:
  • 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 Names:
  • Ad35 TB-S
Biological: MVA85A
Intradermal needle injection 1x10^8 pfu
Other Names:
  • 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 Names:
  • Ad35 TB-S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of AERAS-402 followed by MVA85A
Time Frame: 3 months after final vaccination
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
3 months after final vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity of AERAS-402 followed by MVA85A
Time Frame: 12-18 months after first vaccination
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
12-18 months after first vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Crucell Holland BV
University of Birmingham
Emergent BioSolutions
Aeras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 24, 2012

First Submitted That Met QC Criteria

September 7, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 16, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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