A Phase I Study to Assess the Safety and Immunogenicity of Tuberculosis (TB) Vaccine Candidates FP85A and MVA85A

NCT00653770 | Completed Phase 1 DMC

• 1 other identifier: TB017
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase I study whose primary outcome is to assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG. The secondary outcome is to assess the cellular immune response in the same population. The trial consists of 36 subjects in 3 groups. The first group will be vaccinated with FP85A alone, the second group will be vaccinated with MVA85A followed by FP85A 28 days later and the third group will be vaccinated with FP85A followed by MVA85A 28 days later.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (1)

• To assess the safety of a new tuberculosis vaccine, FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime, to healthy volunteers, who have previously been vaccinated with BCG

  3 months

Secondary Outcomes (1)

• To assess the cellular immune response generated by FP85A, when administered individually and sequentially with MVA85A in a prime-boost regime to healthy volunteers, who have previously been vaccinated with BCG.

  12 months

Study Arms (3)

1

EXPERIMENTAL

FP85A at day 0

Biological: FP85A

2

EXPERIMENTAL

MVA85A at day 0 and FP85A at day 28

Biological: FP85A; Biological: MVA85A

3

EXPERIMENTAL

FP85A at day 0 and MVA85A at day 28

Biological: FP85A; Biological: MVA85A

Interventions

FP85A BIOLOGICAL

Recombinant Fowlpox virus 9 expressing antigen 85A from M. tuberculosis (5 x10\^7 pfu)

1; 2; 3

MVA85A BIOLOGICAL

Modified vaccinia virus Ankara expressing antigen 85A from M. tuberculosis (5 x 10\^7 pfu)

2; 3

Eligibility Criteria

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

You may qualify if:

• Healthy adult aged 18 to 50 years
• Resident in or near Oxford for the duration of the vaccination study
• Immunization with BCG greater than 12 months prior to enrolment in the study
• Able and willing (in the Investigators' opinions) to comply with all study requirements
• Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
• Agreement to practice barrier contraception from the start of the study until 3 months after the final vaccination
• For females, a negative pregnancy test on the day of vaccination and agreement to practice effective contraception for the entire duration of the study
• Agreement to refrain from blood donation during the course of the study
• Written informed consent

You may not qualify if:

• Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
• Prior receipt of a recombinant MVA or fowlpox vaccine
• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
• Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
• Any history of anaphylaxis in reaction to vaccination
• Close contact with fowl during the study period (e.g. chicken farming)
• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• History of serious psychiatric condition
• Any other chronic illness requiring hospital specialist supervision
• Suspected or known current injecting drug or alcohol abuse (as defined by an alcohol intake of greater than 42 units every week)
• Seropositive for hepatitis B surface antigen (HBsAg)
• Seropositive for hepatitis C virus (antibodies to HCV)
• For females, pregnancy, lactation or willingness/intention to become pregnant during the study
• Any other significant disease, disorder or finding, which, in the opinion of the Investigators, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate in the study.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

CCVTM, University of Oxford

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (1)

• Rowland R, Pathan AA, Satti I, Poulton ID, Matsumiya MM, Whittaker M, Minassian AM, O'Hara GA, Hamill M, Scott JT, Harris SA, Poyntz HC, Bateman C, Meyer J, Williams N, Gilbert SC, Lawrie AM, Hill AV, McShane H. Safety and immunogenicity of an FP9-vectored candidate tuberculosis vaccine (FP85A), alone and with candidate vaccine MVA85A in BCG-vaccinated healthy adults: a phase I clinical trial. Hum Vaccin Immunother. 2013 Jan;9(1):50-62. doi: 10.4161/hv.22464. Epub 2012 Nov 10.

  PMID: 23143773 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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2008
• First Posted: April 7, 2008
• Study Start: September 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 9, 2010

Record last verified: 2010-02

Locations

GB (1)