INH-A21: a donor-selected Staphylococcal human immune globulin for the prevention of late-onset neonatal Staphylococcal infection

Abstract

INH-A21 is an experimental human immune globulin for intravenous infusion (IGIV) derived from donors specifically selected for elevated levels of antibodies against the Staphylococcal fibrinogen-binding proteins, serine aspartate dipeptide repeat G and clumping factor A. Phase II results demonstrated that infusions of INH-A21 were well tolerated and there were no trends for increasing adverse events, or the common morbidities associated with prematurity. Enrolment has been completed in (but no results have been released from) a Phase III human trial testing INH-A21 as a prophylactic agent against staphylococcal infection in very low birth weight infants (500 – 1250 g).

Keywords::

• human immune globulin
• late-onset sepsis
• neonate
• Staphylococcus