colonization factor antigen I subunit vaccine + mutant heat-labile toxin adjuvant

The colonization factor antigen I subunit vaccine + mutant heat-labile toxin adjuvant is an investigational combination vaccine developed for the prevention of enterotoxigenic *Escherichia coli* (ETEC) infections, a major cause of diarrheal disease in travelers and children in low- and middle-income countries. The vaccine consists of a recombinant subunit antigen targeting the colonization factor antigen I (CFA/I) fimbriae—specifically the minor tip adhesin subunit CfaE (often stabilized as donor strand-complemented CfaE, dscCfaE, or fused as CfaEB)—co-administered with a mutated form of ETEC heat-labile enterotoxin (LT) as a mucosal adjuvant. The adjuvant component is typically either a single-mutant LT (mLT, such as LTR192G) or a double-mutant LT (dmLT, such as LTR192G/L211A), which are genetically detoxified to retain immunogenicity and adjuvanticity while minimizing enterotoxicity. Administered primarily via intradermal or transcutaneous routes, the vaccine stimulates robust systemic and mucosal immune responses, including serum IgG and IgA antibodies and antibody-secreting cells (ASCs) targeting both the CFA/I adhesin and the LT toxin, thereby blocking bacterial adherence to the intestinal epithelium and neutralizing the enterotoxin.

Other names

CfaE + dmLTCfaE + mLTCfaE-LTB + dmLTCfaE-LTB + mLTCfaEB + dmLTCfaEB + mLTcolonization factor antigen I subunit vaccine + double mutant heat-labile toxin adjuvantcolonization factor antigen I subunit vaccine + mutant heat-labile enterotoxin adjuvantcolonization factor antigen I subunit vaccine + mutant heat-labile toxindscCfaE + LTR192GdscCfaE + LTR192G/L211AdscCfaE + dmLTdscCfaE + mLT