TABLE 4.

Number of subjects with mucosal immune responses to CFA/IIa after one or two oral doses of attenuated ETEC strain PTL-002 or PTL-003

AssayImmunoglobulinVaccineNo. of respondersb (%) after one doseNo. of new responders (%) after second dosecTotal no. of responders (%) after one or two dosesPd
ASCIgAPTL-00210/20 (50)1/4 (25)11/20 (55)0.01
PTL-00315/20 (75)3/5 (60)18/20 (90)
IgGPTL-0026/20 (30)0/7 (0)6/20 (30)0.20
PTL-0039/20 (45)1/7 (14)10/20 (50)
ALSIgAPTL-0029/20 (45)0/5 (0)9/20 (45)0.06
PTL-00311/20 (55)4/7 (57)15/20 (75)
IgGPTL-0023/20 (15)1/8 (13)4/20 (20)0.17
PTL-0036/20 (30)2/9 (22)8/20 (40)
  • a The response in the ASC assay is ≥2-fold increase over the baseline and >1.0 spots/106 PBMC. The response in the ALS assay is ≥2-fold increase over the baseline.

  • b Responders/total number of subjects in group (%).

  • c Subjects in the two-dose group who did not respond to the first dose but did respond to the second dose given on day 10/all subjects in the two-dose group who did not respond to the first dose (%).

  • d Chi-square or Fisher's exact test comparison of total responders to PTL-002 versus total responders to PTL-003.