Site for A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY TOLERABILITY IMMUNOGENICITY AND IMMUNOPERSISTENCE OF A CLOSTRIDIOIDES DIFFICILE VACCINE ADMINISTERED IN A 2-DOSE REGIMEN WITH NOVEL ADJUVANTS IN HEALTHY ADULTS

Brief description of study

This Phase 1/2 study in adults greater than 65 years of age will evaluate the safety and immunogenicity of Clostridioides (formerly Clostridium) difficile vaccine formulations containing a CpG adjuvant or LiNA. Phase 1 is intended to assess whether these novel adjuvanted formulations will show a similar safety profile with improved immunogenicity (more rapid rise in protective antibodies with maintained durability) in a 2-dose regimen when compared to the Al(OH)3-containing vaccine formulation in a 3-dose regimen. Phase 2 is intended to further evaluate the safety and immunogenicity of the high-dose CpG-adjuvanted C difficile vaccine formulation administered in a 2-dose regimen in healthy adults. Phase 2 will also explore the optimal dosing schedule (0- and 1-month or 0- and 2-month) and examine antibody persistence for up to 4 years after the last dose of C difficile vaccine in the primary series, with or without administration of a booster dose.


Clinical Study Identifier: s24-00249
ClinicalTrials.gov Identifier: NCT05805826
Principal Investigator: Lalitha Parameswaran.
Other Investigators: Robert Anwar Pitts, Mark J. Mulligan, Tamia Davis, Angelica Cifuentes Kottkamp, Madeline Alexandra DiLorenzo, Andrew Banks Fleming, Celia Engelson, Ellie R. Carmody.


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