Study Evaluating Aerosol and Intradermal Administration of a Candidate Tuberculosis (TB) Vaccine, MVA85A, as a Way to Increase Immune Response and Avoid Anti-vector Immunity

NCT01954563 | Completed Phase 1 DMC

• 1 other identifier: TB035
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Boost vaccinations sometimes have no effect because the body has got used to the vaccine and no longer reacts to it. We are therefore investigating whether vaccinating with aerosolised MVA85A (a candidate tuberculosis vaccine) followed by a boost MVA85A intradermal vaccination (or vice versa) avoids this and increases the immune response to vaccination.

Conditions

Tuberculosis

Keywords

Tuberculosis; Vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Safety of 5 x 10^7 pfu dose of MVA85A administered by aerosol and compared to the same dose administered intradermally

  Actively and passively collected data on adverse events

  24 weeks from enrolment

Secondary Outcomes (1)

• Immunogenicity of 5 x 10^7 pfu dose of MVA85A administered by aerosol followed by the same dose administered intradermally, compared to the same dose of MVA85A given intradermally and boosted by aerosol

  24 weeks from enrolment

Study Arms (3)

Group 1

EXPERIMENTAL

Receive 5x10\^7 MVA85A by aerosol at day 0, followed by boost intradermal vaccination of 5x10\^7 MVA85A at day 28.

Biological: MVA85A

Group 2

EXPERIMENTAL

Receive 5x10\^7 MVA85A by intradermal injection at day 0, followed by boost aerosol vaccination of 5x10\^7 MVA85A at day 28.

Biological: MVA85A

Group 3

EXPERIMENTAL

Receive 5x10\^7 MVA85A by intradermal injection at day 0, followed by boost intradermal vaccination of 5x10\^7 MVA85A at day 28.

Biological: MVA85A

Interventions

MVA85A BIOLOGICAL

Modified vaccinia virus Ankara (MVA) is a highly attenuated strain of vaccinia with an antigen 85A insert.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet all of the following criteria to enter the trial:
• Healthy adult aged 18-55 years
• Resident in or near Oxford 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

You may not qualify if:

• Subjects must meet none of the following criteria to enter the trial:
• Any respiratory disease, including asthma
• Current smoker
• Clinically significant abnormality on screening chest x-ray
• Clinically significant abnormality of pulmonary function tests
• Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy
• Current use of any medication taken through the nasal or inhaled route including cocaine or other recreational drugs
• 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
• Previous vaccination with candidate vaccine MVA85A or candidate vaccine FP85A or any other recombinant MVA vaccine
• 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, sedative drugs, or any local or general anaesthetic agents
• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Related Publications (1)

• Manjaly Thomas ZR, Satti I, Marshall JL, Harris SA, Lopez Ramon R, Hamidi A, Minhinnick A, Riste M, Stockdale L, Lawrie AM, Vermaak S, Wilkie M, Bettinson H, McShane H. Alternate aerosol and systemic immunisation with a recombinant viral vector for tuberculosis, MVA85A: A phase I randomised controlled trial. PLoS Med. 2019 Apr 30;16(4):e1002790. doi: 10.1371/journal.pmed.1002790. eCollection 2019 Apr.

  PMID: 31039172 DERIVED

Related Links

• Jenner Institute Clinical Trials

MeSH Terms

Conditions

Tuberculosis

Interventions

MVA 85A

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Helen McShane

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 1, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

GB (1)