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 10^a

Subject	PTL vaccine regimen Day 0/ day 10	Anti-CS1 IgA titer on day:						Anti-CS3 IgA titer on day:						IgA-ASCs/106 PBMC on day:				No. of positive stool culturesb at days:
		0	7	10	17	24	38	0	7	10	17	24	38	0	7	10	17	1 to 10	11 to 25
33	002/—	39	40	70	75	48	53	89	99	125	121	92	74	0.0	1.0	0.0	0.0	0	3
38	002/—	<20	<20	<20	<20	<20	<20	86	118	119	96	101	132	0.3	2.0	0.0	0.0	2	2
44	002/—	<20	<20	NS	NS	NS	NS	<20	<20	NS	NS	NS	NS	0.0	0.0	0.0	NS	0	0
59	002/—	<20	<20	<20	<20	<20	<20	39	40	48	39	48	40	0.0	3.0	0.7	0.3	1	0
62	002/—	221	281	339	573	468	490	392	654	872	757	545	434	1.7	101.0	43.7	10.0	1	0
69	002/—	<20	<20		<20	<20	<20	27	29		30	31	30	0.7	0.3	NS	0.3	1	0
31	—/002	<20	35	33	51	51	37	58	59	50	76	77	59	0.0	0.0	0.0	0.7	0	0
40	—/002	32	114	49	76	33	79	279	43	259	271	470	607	0.0	0.3	0.0	1.0c	0	3
50	—/002	23	<20	<20	<20	<20	29	33	32	30	38	36	36	0.0	0.0	0.3	1.0	0	1
54	—/002	83	55	78	39	<20	<20	<20	<20	<20	<20	<20	<20	0.7	0.0	0.0	0.7	0	2
30	002/002	575	528	680	701	670	874	478	539	586	740	631	695	0.0	1.7	0.0	5.7	1	0
41	002/002	<20	<20	<20	<20	<20	<20	303	768	1,188	1,132	1,098	1,091	0.3	81.0	16.7	1.0	0	1
42	002/002	72	136	346	363	248	101	48	44	41	59	53	48	0.0	15.3	2.3	2.0	1	2
46	002/002	128	255	455	565	390	295	130	199	297	292	249	201	0.0	9.6	9.0	0.0	1	1
48	002/002	<20	<20	<20	<20	<20	<20	44	38	54	44	45	54	0.0	0.7	0.0	0.0	0	1
52	002/002	47	514	409	276	183	102	480	1,011	>1,280	>1,280	1,251	1,128	5.0	28.7	8.3	14.7	1	2
53	002/002	29	30	25	29	30	21	151	144	156	152	151	149	5.0	6.7	0.3	6.0	1	1
60	002/002	<20	<20	<20	<20	<20	<20	<20	<20	<20	21	<20	<20	0.0	0.3	0.0	0.0	1	0
64	002/002	<20	<20	<20	<20	<20	<20	394	377	443	498	478	490	0.0	0.0	0.0	1.3	0	0
71	002/002	24	20	20	24	22	<20	40	58	73	72	77	76	0.0	1.0	1.3	1.7	0	1
34	003/—	57	39	44	52	39	67	180	156	214	194	151	156	0.0	8.3	2.0	0.0	3	0
37	003/—	37	34	39	41	104	120	77	106	132	219	292	210	0.0	3.3	4.3	45.7	2	4
45	003/—	26	24	23	100	80	73	73	249	489	1,074	570	215	0.0	175.3	41.3	6.0	3	2
57	003/—	<20	25	<20	153	121	73	31	288	325	626	277	64	0.0	22.0	43.3	13.0	3	1
65	003/—	32	32	<20	59	<20	<20	70	614	1,158	645	602	346	0.3	60.3	12.3	NS	3	1
32	—/003	<20	31	21	44	148	163	509	424	377	583	1,217	580	2.7	1.7	1.0	28.7	0	4
39	—/003	<20	<20	<20	<20	792	1,051	84	39	93	93	344	178	3.0	14.0	4.3	83.0	0	4
66	—/003	<20	<20	39	32	<20	<20	203	197	439	361	490	245	0.0	0.0	0.0	2.3	0	3
68	—/003	<20	<20	<20	<20	<20	NS	314	104	140	182	362	NS	0.0	0.0	0.7	6.0	0	0
35	003/003	39	39	40	40	40	40	74	71	70	73	74	80	0.0	1.3	0.3	0.3	1	2
36	003/003	<20	39	60	<20	27	<20	464	680	517	543	568	607	0.0	0.0	0.0	0.0	1	1
43	003/003	31	34	28	57	131	64	108	116	102	156	223	112	0.0	0.0	0.0	10.0	2	1
47	003/003	89	114	98	141	149	138	276	295	250	303	546	527	0.0	0.0	0.0	11.0	0	1
49	003/003	53	39	90	57	61	37	192	267	507	252	285	118	0.3	9.6	8.7	2.0	1	1
51	003/003	260	460	897	907	1,205	812	122	517	629	879	1,121	933	0.3	70.0	38.6	6.7	2	0
55	003/003	<20	<20	39	272	130	84	63	1,118	1,155	993	314	151	0.0	51.7	29.3	7.7	3	1
56	003/003	<20	<20	<20	<20	<20	<20	36	152	224	144	80	117	0.0	15.7	0.7	6.7	0	1
58	003/003	109	115	125	146	252	207	935	748	1094	1,038	837	999	0.7	62.7	30.3	46.3	1	0
67	003/003	<20	27	<20	<20	99	61	22	31	<20	51	1,108	159	0.0	0.0	0.0	23.0	1	4
70	003/003	<20	<20	<20	<20	<20	<20	27	29	32	29	30	29	0.0	0.0	0.0	0.0	2	1

^aBoldface 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.

^bStool samples were obtained for culture on 4 days from days 0 to 10 and 4 days from days 11 to 25.

^cResponder day 38 (ASC-3.7). (This is the only subject with a response at day 38 only.)