A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers.

NCT00423566 | Completed Phase 1

• 1 other identifier: TB002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis). This vaccine is delivered intrdermally by a needle injection in healthy volunteers.

Conditions

Tuberculosis

Keywords

Mycobacterium tuberculosis; 85A antigen; Recombinant Modified Vaccinia virus Ankara; Phase I study; Immunogenicity

Outcome Measures

Primary Outcomes (4)

• Local and systemic reactions will be monitored 30 and 60 minutes after administration.

• A photograph of the injection will be taken at 48 hours and this injection site will be reviewed 7 days after each immunisation.

• Blood will be taken: 1 week after the first vaccination, 1 week after the second vaccination and then at 4, 8, 12 and 24 weeks. The blood is used for a full blood count and biochemical screen.

• Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).

Secondary Outcomes (1)

• Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).

Interventions

MVA85A (Tuberculosis vaccine) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult aged 18-45 years.
• Normal medical history and physical examination.
• Normal urine dipstick, blood count, liver enzymes, and creatinine.

You may not qualify if:

• Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
• Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
• Oral or systemic steroid medication or the use of immunosuppressive agents.
• Positive HIV antibody test, HCV antibody test or positive HBV serology except post-vaccination.
• Positive Heaf test
• Confirmed pregnancy
• Previous MVA immunisations

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Tuberculosis

Interventions

MVA 85A; Tuberculosis Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Helen McShane, MD and PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: September 1, 2002
• Study Completion: July 1, 2003
• Last Updated: January 18, 2007

Record last verified: 2006-12

Locations

GB (1)