Safety of Tuberculosis Vaccine, MVA85A, Administered by the Intramuscular Route and the Intradermal Route

NCT01181856 | Completed Phase 1 DMC

• 1 other identifier: TB022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I study that will compare the safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route in healthy adult individuals who have been previously vaccinated with Bacillus Calmette-Guerin (BCG).

Conditions

Tuberculosis

Keywords

Vaccine; MVA 85A

Outcome Measures

Primary Outcomes (1)

• Safety

  Safety data in both groups, as assessed by the frequency, incidence, and nature of adverse events (AEs) and serious adverse events (SAEs) during the study. Safety is measured throughout the 6 months follow up period, but specifically on the following days: 2, 7, 14, 28, 56, 84 and 168 and. Blood for safety testing is taken at Days 7 and 28.

  6 months following vaccination

Secondary Outcomes (1)

• Immunogenicity

  6 months following vaccination

Study Arms (2)

Group A

EXPERIMENTAL

Intramuscular immunisation

Biological: MVA 85A

Group B

EXPERIMENTAL

Intradermal immunisation

Biological: MVA 85A

Interventions

MVA 85A BIOLOGICAL

Single injection of 1 x 108 pfu MVA85A

Group A; Group B

Eligibility Criteria

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

You may qualify if:

• Healthy adult aged 18 - 55 years (both male and female)
• Resident in or near Oxford for the duration of the study period
• Confirmation of prior vaccination with BCG not less than 3 months prior to projected study vaccination date (by visible BCG scar on examination or written documentation)
• Normal medical history and physical examination
• Willingness to allow the Investigators to discuss the individual's medical history with their GP
• Willingness to use continuous effective barrier contraception for three months after receiving the vaccination (males and females)
• Willingness to use effective contraception for the duration of the study period (females only)
• Agreement to refrain from blood donation during the course of the study
• Give written informed consent
• Agreement to allow the Investigator to register volunteer 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 study requirements

You may not qualify if:

• Clinical, radiological, or laboratory evidence of current active TB infection
• Laboratory evidence at screening of latent TB infection as indicated by a positive ELISPOT test (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide poola
• Previous vaccination with candidate vaccine MVA85A or another recombinant MVA vaccine
• Clinically significant history of skin disorder, allergy, immunodeficiency (including human immunodeficiency virus \[HIV\]), cancer (except basal cell carcinoma \[BCC\] or carcinoma in situ \[CIS\]), cardiovascular disease, respiratory 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 use of other immunosuppressive agents
• History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study vaccine
• Any clinically significant abnormality of screening blood or urine tests
• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or HIV antibodies
• Female currently lactating, confirmed pregnancy or intention to become pregnant during study period
• Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the study vaccine for 30 days prior to dosing with the study vaccine, or planned use during the study 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 volunteer at risk or may influence the result of the study or may affect the volunteer's ability to participate in the study

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Centre of Clinical Vaccinology and Tropical Medicine (CCVTM) Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (1)

• Meyer J, Harris SA, Satti I, Poulton ID, Poyntz HC, Tanner R, Rowland R, Griffiths KL, Fletcher HA, McShane H. Comparing the safety and immunogenicity of a candidate TB vaccine MVA85A administered by intramuscular and intradermal delivery. Vaccine. 2013 Feb 4;31(7):1026-33. doi: 10.1016/j.vaccine.2012.12.042. Epub 2012 Dec 21.

  PMID: 23266342 DERIVED

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

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 13, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 28, 2011

Record last verified: 2011-03

Locations

GB (1)