Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial.

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Grode L, Ganoza CA, Brohm C, Weiner J 3rd, Eisele B, Kaufmann SH

Safety and immunogenicity of the recombinant BCG vaccine VPM1002 in a phase 1 open-label randomized clinical trial.

Vaccine. 2013 Feb 18;31(9):1340-8. doi: 10.1016/j.vaccine.2012.12.053. Epub 2013 Jan 3.

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23290835 [ View in PubMed
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Abstract

BACKGROUND: Current vaccination using Mycobacterium bovis bacillus Calmette-Guerin (BCG), fails to prevent pulmonary tuberculosis (TB). New vaccination strategies are essential for reducing the global incidence of TB. We assessed the safety and immunogenicity of VPM1002, a recombinant BCG vaccine candidate. EudraCT (2007-002789-37) and ClinicalTrials.gov (NCT00749034). METHODS: Healthy volunteers were enrolled in a phase 1 open-label, dose escalation randomized clinical trial, and received one intradermal dose of VPM1002 (Mycobacterium bovis BCG DeltaureC::hly Hm(R)) or BCG. Immunogenicity was assessed by interferon-gamma (IFN-gamma) production, cellular immune response markers by flow cytometry and serum antibodies against mycobacterial antigens. RESULTS: Eighty volunteers were randomized into two groups according to previous BCG vaccination and mycobacterial exposure (BCG-naive, n=40 and BCG-immune, n=40). In each group, 30 individuals were vaccinated with VPM1002 (randomized to three escalating doses) and 10 with BCG. VPM1002 was safe and stimulated IFN-gamma-producing and multifunctional T cells, as well as antibody-producing B cells in BCG-naive and BCG-immune individuals. CONCLUSIONS: VPM1002 was safe and immunogenic for B-cell and T-cell responses and hence will be brought forward through the clinical trial pipeline.

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