A phase IIa Trial of the new TB Vaccine, MVA85A, in HIV and/or M. Tuberculosis Infected Adults
- Department for International Development
- Document Type:
- Journal Article
- Moyo, S., van der Merwe, L., Hughes, E.J., McShane, H., Brittain, N. de Kock, M., Geldenhuys, H., Gelderbloem, S., Hanekom, W.A., Hatherill, M., Hawkridge, A., Hill, A.V., Hussey, G.D., Kadira, B., Lawrie, A., Mahomed, H., Makhethe, L., Mauff, K., Mulenga, H., Scriba, T.J., Smit, E., Tameris, M., van Rensburg, E.J., and Veldsman, A.
Rationale: Novel tuberculosis (TB) vaccines should be safe and effective in populations infected with Mycobacterium tuberculosis (M.tb) and/or HIV for effective TB control.
Objective: To determine the safety and immunogenicity of MVA85A, a novel TB vaccine, among M.tb and/or HIV-infected persons in a setting where TB and HIV are endemic.
Methods: An open-label, phase IIa trial was conducted in 48 adults with M.tb and/or HIV infection. Safety and immunogenicity were analyzed up to 52 weeks after intradermal vaccination with 5 x 107 plaque forming units of MVA85A. Specific T cell responses were characterized by IFN-γ ELISpot and whole blood intracellular cytokine staining assays.
Measurements and Main Results: MVA85A was well tolerated and no vaccine-related serious adverse events were recorded. MVA85A induced robust and durable response of mostly polyfunctional CD4 T cells, co-expressing IFN-γ, TNF-α and IL-2. Magnitudes of pre- and post-vaccination T cell responses were lower in HIV-infected, compared with HIV-uninfected, vaccinees. No significant effect of ART on immunogenicity of MVA85A was observed.
Conclusions: MVA85A was safe and immunogenic in persons with HIV and/or M.tb infection. These results support further evaluation of safety and efficacy of this vaccine for prevention of TB in these target populations.
Scriba, T.J.; Tameris, M.; Smit, E.; van der Merwe, L.; Hughes, E.J.; Kadira, B.; Mauff, K.; Moyo, S.; Brittain, N.; Lawrie, A.; Mulenga, H.; de Kock, M.; Makhethe, L.; van Rensburg, E.J.; Gelderbloem, S.; Veldsman, A.; Hatherill, M.; Geldenhuys, H.; Hill, A.V.; Hawkridge, A.; Hussey, G.D.; Hanekom, W.A.; McShane, H.; Mahomed, H. A Phase IIa Trial of the New Tuberculosis Vaccine, MVA85A, in HIV- and/or Mycobacterium tuberculosis-infected Adults. American Journal of Respiratory and Critical Care Medicine (2012) 185 (7) 769-778. [DOI: 10.1164/rccm.201108-1548OC]
Document Type: Journal Article
Authors: Moyo, S. van der Merwe, L. Hughes, E.J. McShane, H. Brittain, N. de Kock, M. Geldenhuys, H. Gelderbloem, S. Hanekom, W.A. Hatherill, M. Hawkridge, A. Hill, A.V. Hussey, G.D. Kadira, B. Lawrie, A. Mahomed, H. Makhethe, L. Mauff, K. Mulenga, H. Scriba, T.J. Smit, E. Tameris, M. van Rensburg, E.J. Veldsman, A.