A Phase I Study of the Safety and Immunogenicity of MVA85A in Healthy Gambian Volunteers

NCT00423839 | Completed Phase 1

• 1 other identifier: AFTBVAC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian volunteers

Conditions

Tuberculosis

Keywords

Mycobacterium tuberculosis; Antigen 85A; Modified Vaccinia Virus Ankara (MVA).

Outcome Measures

Primary Outcomes (1)

• Safety of the Vaccine. This will be determined by the degree and number of adverse events reported.

Secondary Outcomes (1)

• Immunogenicity of this vaccine. It is expected that the vaccine will stimulate T cell responses, which will be measured by interferon -gamma Elispot assays.

Interventions

MVA85A (Tuberculosis vaccine) BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

• Healthy adult male aged 18-45 years.
• Normal medical history and physical examination. Minor physical ailments e.g. Fungal skin infections, will not be sufficient to define a physical examination as abnormal.
• Normal urine dipstick, blood count, liver enzymes, and creatinine
• Frequency \<4 SFU per/well/3x105 PBMC as determined by ELISPOT with ESAT6/CFP-10 antigens and less than 100 SFU per/well/1x106 PBMC as determined by ELISPOT with PPD.
• Mantoux negative (0.0 mm induration).
• Normal Chest X-ray.
• Willing to donate blood samples as required by the protocol

You may not qualify if:

• Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease or neurological illness.
• Any clinical evidence of immunosuppression such as oral candida, stomatitis, aphthous or septic ulceration, septic skin lesions or any clinical or laboratory evidence of infection or immunocompromise.
• History of splenectomy
• Haematocrit of less than 30%
• Serum creatinine concentration \>130mmol
• Serum ALT concentration \>80IU/L
• Blood transfusion within one month of the beginning of the study
• History of vaccination with any previous experimental poxvirus vaccine
• Administration of any other vaccine or immunoglobulin within two weeks before or two weeks after vaccination.
• Current participation in another clinical trial, or within 12 weeks of this study
• Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
• Likelihood of travel away from the study area for the duration of the study
• Untreated malaria infection

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

MRC Labs

Fajara, Fajara, The Gambia

Location

Related Publications (2)

• Ibanga HB, Brookes RH, Hill PC, Owiafe PK, Fletcher HA, Lienhardt C, Hill AV, Adegbola RA, McShane H. Early clinical trials with a new tuberculosis vaccine, MVA85A, in tuberculosis-endemic countries: issues in study design. Lancet Infect Dis. 2006 Aug;6(8):522-8. doi: 10.1016/S1473-3099(06)70552-7.

  PMID: 16870530 RESULT

• Brookes RH, Hill PC, Owiafe PK, Ibanga HB, Jeffries DJ, Donkor SA, Fletcher HA, Hammond AS, Lienhardt C, Adegbola RA, McShane H, Hill AV. Safety and immunogenicity of the candidate tuberculosis vaccine MVA85A in West Africa. PLoS One. 2008 Aug 13;3(8):e2921. doi: 10.1371/journal.pone.0002921.

  PMID: 18698342 DERIVED

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: March 1, 2003
• Study Completion: July 1, 2005
• Last Updated: January 18, 2007

Record last verified: 2006-12

Locations

TH (1)