TABLE 2.

Incidence of gastrointestinal and general symptoms reported by subjects during the 7 days after ingestion of PTL-002, PTL-003, or placebo on days 0 and 10a

SymptomsIncidence (%)P (PTL-002/ PTL-003 vs placebo)d
PTL-002 (n = 30)bPTL-003 (n = 31)bPlacebo (n = 18)c
Unformed stools3 (10)4 (13)4 (22)0.4/0.4
Diarrheae0 (0)1 (3)0 (0)1.0/1.0
Appetite loss0 (0)1 (3)0 (0)1.0/1.0
Abdominal cramps7 (23)2 (7)3 (17)0.7/0.3
Vomiting0 (0)0 (0)1 (6)1.0/1.0
Fever (T > 100.4°F)0 (0)0 (0)0 (0)1.0/1.0
Malaise3 (10)2 (7)0 (0)0.3/0.5
Lightheadedness3 (10)3 (10)0 (0)0.3/0.3
Headache5 (17)6 (19)3 (17)1.0/1.0
Muscle aches1 (3)0 (0)1 (6)1.0/0.3
  • a Volunteers ingested PTL-002 or PTL-003 in 200 ml of CeraVacx buffer. The placebo was CeraVacx buffer alone.

  • b Of the 32 planned PTL-002 dosings, one subject was lost to follow-up after dose 1 and a second did not receive the second dose. Of the 32 planned PTL-003 dosings, one subject did not receive the second dose.

  • c In addition to the 16 planned placebo dosings, this group includes two subjects who did not receive a second dose of PTL-002 or PTL-003 but returned for subsequent follow-up visits.

  • d Vaccine recipients were compared to the placebo group by Fisher's exact test.

  • e Diarrhea was defined as ≥3 unformed stools in a 24-h period. One subject had three loose stools 1 day after his second dose of PTL-003. Another subject had four loose stools 9 days after his only dose of PTL-003 and is not included in the table since diarrhea was not within 7 days of dosing.