A Study of 2 Doses of a New TB Vaccine, MVA85A, in Healthy Volunteers Previously Vaccinated With BCG

NCT00465465 | Completed Phase 1

• 1 other identifier: TB009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The dose of recombinant MVA used in the TB trials to date is relatively low compared with other trials using recombinant MVAs which have used up to 2.5 x 108pfu (A Hill, personal communication). Having demonstrated safety and immunogenicity of 5 x 107pfu of MVA85A, we now need to perform a dose optimization study, prior to commencing larger scale Phase II and III studies in South Africa. We will vaccinate 12 volunteers with a dose half a log lower than the dose we are currently using, i.e. 107pfu MVA85A, and 12 volunteers with a dose half a log higher, i.e. 108pfu.

Conditions

Tuberculosis

Keywords

Tuberculosis; TB; MVA 85A; BCG

Outcome Measures

Primary Outcomes (1)

• To assess the safety and immunogenicity of 2 different doses of intradermal vaccination of MVA85A, 10^7pfu and 10^8pfu, when administered to healthy subjects who have previously been vaccinated with BCG

  1 year

Study Arms (2)

1

ACTIVE COMPARATOR

Dose of 1 x 10\^7

Biological: MVA 85A

2

ACTIVE COMPARATOR

Dose of 1 x 10\^8

Biological: MVA 85A

Interventions

MVA 85A BIOLOGICAL

i.d. injection

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18 to 50 years
• Resident in or near Oxford for the duration of the vaccination study
• Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's GP
• Screening Elispot negative (less than 10 sfc/million PBMC) for all 3 ESAT6 peptide pools and all 3 CFP10 peptide pools
• Mantoux test not greater than 15 millimetres
• For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination
• Agreement to refrain from blood donation during the course of the study
• Written informed consent
• Willingness to undergo an HIV test

You may not qualify if:

• Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis as defined in Appendix I
• Mantoux greater than 15 millimetres
• Prior receipt of a recombinant MVA or Fowlpox vaccine
• Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
• Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
• Evidence of cardiovascular disease
• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• History of insulin requiring diabetes mellitus
• Chronic or active neurological disease requiring ongoing specialist supervision
• Chronic gastrointestinal disease requiring ongoing specialist supervision
• History of \> 2 hospitalisations for invasive bacterial infections (pneumonia, meningitis)
• Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• Seropositive for hepatitis B surface antigen (HBsAg)

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford, CCVTM, Churchill Hospital

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 24, 2007
• First Posted: April 25, 2007
• Study Start: October 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: April 4, 2008

Record last verified: 2008-03

Locations

GB (1)