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.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00423566
• Date of registration: 17/01/2007
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: September 2002
• Target sample size: 14
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00423566
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Helen McShane, MD and PhD
• Affiliation: University of Oxford

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy adult aged 18-45 years.

- Normal medical history and physical examination.

- Normal urine dipstick, blood count, liver enzymes, and creatinine.

Exclusion Criteria:

- 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Biological: MVA85A (Tuberculosis vaccine)

Primary Outcome(s)

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

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.

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.

Secondary Outcome(s)

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

Secondary ID(s)

TB002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors