US 11,865,168 B2
Compositions and methods for treating bacterial infections
Alexander K. Shalek, Cambridge, MA (US); Travis Hughes, Cambridge, MA (US); Marc H. Wadsworth, Cambridge, MA (US); Robert Seder, Bethesda, MD (US); Mario Roederer, Bethesda, MD (US); Joanne L. Flynn, Pittsburgh, PA (US); and Patricia Darrah, Bethesda, MD (US)
Assigned to Massachusetts Institute of Technology, Cambridge, MA (US); The United States of America, as represented by The Secretary, Department of Health & Human Services, Bethesda, MD (US); and University of Pittsburgh—Of The Commonwealth System of Higher Education, Pittsburgh, PA (US)
Filed by Massachusetts Institute of Technology, Cambridge, MA (US); The United States of America, as represented by The Secretary, Department of Health & Human Services, Bethesda, MD (US); and University of Pittsburgh—Of The Commonwealth System of Higher Education, Pittsburgh, PA (US)
Filed on Dec. 30, 2020, as Appl. No. 17/137,481.
Claims priority of provisional application 62/954,998, filed on Dec. 30, 2019.
Prior Publication US 2021/0213126 A1, Jul. 15, 2021
Int. Cl. A61K 39/02 (2006.01); A61K 39/04 (2006.01); A61P 31/06 (2006.01); A61K 39/00 (2006.01)
CPC A61K 39/04 (2013.01) [A61P 31/06 (2018.01); A61K 2039/54 (2013.01)] 2 Claims
 
1. A method of eliciting an enhanced immune response comprising administering intravenously (IV) to a subject in need of prophylactic treatment of Mycobacterium tuberculosis (MTB) a pharmaceutical formulation comprising one or more modulating agents and Bacille Calmette-Guerin (BCG), wherein the one or more modulating agents are selected from the group consisting of an RNA encoding one or more MTB antigens selected from Ag85A and Ag85B, a viral vector encoding one or more MTB antigens selected from Ag85A and Ag85B, and one or more MTB antigens selected from Ag85A and Ag85B, and wherein the one or more modulating agents increase expression of IFNγ, IL-2, TNF, and/or IL-17 in systemic and/or lung T cells; and
confirming an enhanced immune response was elicited in the subject, thereby providing an enhanced immune response for prophylactic treatment, by:
detecting an increased fractional or absolute number of Vγ9+ γδ T cells in a blood sample obtained from the subject; or
detecting an increased proportion of transitional (Ttm) memory cells compared to Central (Tcm) memory cells in a blood sample obtained from the subject.