Safety of new pertussis vaccine candidate based on Bordetella pertussis Outer Membrane Vesicles

DAVID SABATER MARTINEZ; GAILLARD MARÍA EMILIA; MORENO GRISELDA; BOTTERO DANIELA; ERREA AGUSTINA; ZURITA MARÍA EUGENIA; BARTEL ERIKA; RUMBO MARTÍN; DANIELA F. HOZBOR,

BUENOS AIRES

Congreso; IV Congress of LASID (LASID2015); 2015

Sociedad Argentina de Inmunología (SAI).

Pertussis is a current public health problem even in countries with high vaccination coverage. This alarming situation calls for the implementation of new strategies for the disease control. Under this context we designed a new vaccine based on outer membrane vesicles (OMVs) derived from Bordetella pertussis which behaved in an animal model as a very good vaccine candidate. In this work we evaluated the OMVs-vaccine safety. We performed the mouse weight gain test (MWG) and determined the levels of IL-6 used as indicator of proinflammatory response. Human whole blood IL-6 release assays were also used to estimate the endotoxic activities of OMVs-vaccine. For the MWG-test, groups of 8 Balb/c mice outbred mice were i.p. vaccinated with OMVs-vaccine or commercial pertussis vaccines. All vaccine formulations fulfilled the WHO criteria of safety for this test. Mice immunized with OMVs vaccine underwent only small weight loss (less than 1.5% of the original weight) at 16 h, but at 3 days after vaccination, all treated mice regained their weight. The levels of IL-6 showed a rise to 306.21 ± 49.6 pg/mL at 4h post immunization with OMVs-vaccine. For the commercial acellular vaccine used at 1/10 of the human dose, 69.14 ± 9.42 pg/mL was detected. Higher levels were detected with whole-cell vaccine (wP, 6,225 ± 1,554.12 pg/ml). IL-6 mesurements performed in human blood assays showed similar trends for OMVs-vaccine (12-fold lower release than with wP). In conclusion, our OMVs-vaccine seems to be a safe vaccine candidate against pertussis.