TABLE 3.

Serum IgA titers, number of IgA-ASCs, and number of positive stool cultures in subjects given one or two doses of attenuated ETEC strains PTL-002 or PTL-003 on days 0 and 10a

SubjectPTL vaccine regimen Day 0/ day 10Anti-CS1 IgA titer on day:Anti-CS3 IgA titer on day:IgA-ASCs/106 PBMC on day:No. of positive stool culturesb at days:
071017243807101724380710171 to 1011 to 25
33002/—394070754853899912512192740.01.00.00.003
38002/—<20<20<20<20<20<2086118119961011320.32.00.00.022
44002/—<20<20NSNSNSNS<20<20NSNSNSNS0.00.00.0NS00
59002/—<20<20<20<20<20<203940483948400.03.00.70.310
62002/—2212813395734684903926548727575454341.7101.043.710.010
69002/—<20<20<20<20<2027293031300.70.3NS0.310
31—/002<2035335151375859507677590.00.00.00.700
40—/0023211449763379279432592714706070.00.30.01.0c03
50—/00223<20<20<20<20293332303836360.00.00.31.001
54—/00283557839<20<20<20<20<20<20<20<200.70.00.00.702
30002/0025755286807016708744785395867406316950.01.70.05.710
41002/002<20<20<20<20<20<203037681,1881,1321,0981,0910.381.016.71.001
42002/002721363463632481014844415953480.015.32.32.012
46002/0021282554555653902951301992972922492010.09.69.00.011
48002/002<20<20<20<20<20<204438544445540.00.70.00.001
52002/002475144092761831024801,011>1,280>1,2801,2511,1285.028.78.314.712
53002/0022930252930211511441561521511495.06.70.36.011
60002/002<20<20<20<20<20<20<20<20<2021<20<200.00.30.00.010
64002/002<20<20<20<20<20<203943774434984784900.00.00.01.300
71002/0022420202422<204058737277760.01.01.31.701
34003/—5739445239671801562141941511560.08.32.00.030
37003/—37343941104120771061322192922100.03.34.345.724
45003/—2624231008073732494891,0745702150.0175.341.36.032
57003/—<2025<201531217331288325626277640.022.043.313.031
65003/—3232<2059<20<20706141,1586456023460.360.312.3NS31
32—/003<203121441481635094243775831,2175802.71.71.028.704
39—/003<20<20<20<207921,051843993933441783.014.04.383.004
66—/003<20<203932<20<202031974393614902450.00.00.02.303
68—/003<20<20<20<20<20NS314104140182362NS0.00.00.76.000
35003/0033939404040407471707374800.01.30.30.312
36003/003<203960<2027<204646805175435686070.00.00.00.011
43003/00331342857131641081161021562231120.00.00.010.021
47003/00389114981411491382762952503035465270.00.00.011.001
49003/0035339905761371922675072522851180.39.68.72.011
51003/0032604608979071,2058121225176298791,1219330.370.038.66.720
55003/003<20<203927213084631,1181,1559933141510.051.729.37.731
56003/003<20<20<20<20<20<2036152224144801170.015.70.76.701
58003/00310911512514625220793574810941,0388379990.762.730.346.310
67003/003<2027<20<2099612231<20511,1081590.00.00.023.014
70003/003<20<20<20<20<20<202729322930290.00.00.00.021
  • a Boldface subject numbers indicate responders in the anti-CS1 or CS3 IgA antibody assay or the IgA-ASC assay. Boldface antibody titers or ASC numbers indicate response (≥2-fold increase for serum antibody and ≥2-fold increase and >1.0 for ASCs). NS, no show.

  • b Stool samples were obtained for culture on 4 days from days 0 to 10 and 4 days from days 11 to 25.

  • c Responder day 38 (ASC-3.7). (This is the only subject with a response at day 38 only.)