A Randomized, Controlled Dose-Finding Phase II Study of the M72/AS01 Candidate Tuberculosis Vaccine in Healthy PPD-Positive Adults

@inproceedings{Montoya2013ARC,
  title={A Randomized, Controlled Dose-Finding Phase II Study of the M72/AS01 Candidate Tuberculosis Vaccine in Healthy PPD-Positive Adults},
  author={Jaime C. Montoya and Juan Antonio A. Solon and Soledad Rosanna C. Cunanan and L. P. Quevedo Acosta and Anne Bollaerts and Philippe J. Moris and Michel H. Janssens and Erik Jongert and M A Demoiti{\'e} and Pascal Mettens and Salvacion Gatchalian and Carlota Vinals and Joe Cohen and Opokua Ofori-Anyinam},
  booktitle={Journal of Clinical Immunology},
  year={2013}
}
PurposeIn this dose-finding Phase II study (NCT00621322), we evaluated the safety and immunogenicity of different formulations of the candidate tuberculosis vaccine containing the M72 antigen (10/20/40 μg doses) and the liposome-based AS01 Adjuvant System. We aimed to select the lowest-dose combination of M72 and AS01 that was clinically well tolerated with immunogenicity comparable to that of the previously tested M72/AS01B (40 μg) candidate vaccine.MethodsHealthy PPD-positive (induration 3–10… CONTINUE READING
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