A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV

Summary

Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract infection in children under one year of age. This study will evaluate the safety, tolerability and immunogenicity of a recombinant Mycobacterium bovis BCG vaccine that expresses the human Respiratory Syncytial Virus Nucleoprotein (N), in adult males (18 to 50 years of age).

Timeline

Start

2017-06-27

Primary completion

2018-06-01

Completion

2018-06-01

Publications

• Background Bueno SM, Gonzalez PA, Cautivo KM, Mora JE, Leiva ED, Tobar HE, Fennelly GJ, Eugenin EA, Jacobs WR Jr, Riedel CA, Kalergis AM. Protective T cell immunity against respiratory syncytial virus is efficiently induced by recombinant BCG. Proc Natl Acad Sci U S A. 2008 Dec 30;105(52):20822-7. doi: 10.1073/pnas.0806244105. Epub 2008 Dec 15.
• Background Cautivo KM, Bueno SM, Cortes CM, Wozniak A, Riedel CA, Kalergis AM. Efficient lung recruitment of respiratory syncytial virus-specific Th1 cells induced by recombinant bacillus Calmette-Guerin promotes virus clearance and protects from infection. J Immunol. 2010 Dec 15;185(12):7633-45. doi: 10.4049/jimmunol.0903452. Epub 2010 Nov 17.
• Background Cespedes PF, Bueno SM, Ramirez BA, Gomez RS, Riquelme SA, Palavecino CE, Mackern-Oberti JP, Mora JE, Depoil D, Sacristan C, Cammer M, Creneguy A, Nguyen TH, Riedel CA, Dustin ML, Kalergis AM. Surface expression of the hRSV nucleoprotein impairs immunological synapse formation with T cells. Proc Natl Acad Sci U S A. 2014 Aug 5;111(31):E3214-23. doi: 10.1073/pnas.1400760111. Epub 2014 Jul 23.
• Background Palavecino CE, Cespedes PF, Gomez RS, Kalergis AM, Bueno SM. Immunization with a recombinant bacillus Calmette-Guerin strain confers protective Th1 immunity against the human metapneumovirus. J Immunol. 2014 Jan 1;192(1):214-23. doi: 10.4049/jimmunol.1300118. Epub 2013 Dec 6.
• Background Cespedes PF, Rey-Jurado E, Espinoza JA, Rivera CA, Canedo-Marroquin G, Bueno SM, Kalergis AM. A single, low dose of a cGMP recombinant BCG vaccine elicits protective T cell immunity against the human respiratory syncytial virus infection and prevents lung pathology in mice. Vaccine. 2017 Feb 1;35(5):757-766. doi: 10.1016/j.vaccine.2016.12.048. Epub 2017 Jan 5.
• Pacheco GA, Andrade CA, Galvez NMS, Vazquez Y, Rodriguez-Guilarte L, Abarca K, Gonzalez PA, Bueno SM, Kalergis AM. Characterization of the humoral and cellular immunity induced by a recombinant BCG vaccine for the respiratory syncytial virus in healthy adults. Front Immunol. 2023 Jul 18;14:1215893. doi: 10.3389/fimmu.2023.1215893. eCollection 2023.
• Abarca K, Rey-Jurado E, Munoz-Durango N, Vazquez Y, Soto JA, Galvez NMS, Valdes-Ferrada J, Iturriaga C, Urzua M, Borzutzky A, Cerda J, Villarroel L, Madrid V, Gonzalez PA, Gonzalez-Aramundiz JV, Bueno SM, Kalergis AM. Safety and immunogenicity evaluation of recombinant BCG vaccine against respiratory syncytial virus in a randomized, double-blind, placebo-controlled phase I clinical trial. EClinicalMedicine. 2020 Oct 6;27:100517. doi: 10.1016/j.eclinm.2020.100517. eCollection 2020 Oct.

Drugs

Indications