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
| Symptoms | Incidence (%) |
P (PTL-002/ PTL-003 vs placebo)d | ||
|---|---|---|---|---|
| PTL-002 (n = 30)b | PTL-003 (n = 31)b | Placebo (n = 18)c | ||
| Unformed stools | 3 (10) | 4 (13) | 4 (22) | 0.4/0.4 |
| Diarrheae | 0 (0) | 1 (3) | 0 (0) | 1.0/1.0 |
| Appetite loss | 0 (0) | 1 (3) | 0 (0) | 1.0/1.0 |
| Abdominal cramps | 7 (23) | 2 (7) | 3 (17) | 0.7/0.3 |
| Vomiting | 0 (0) | 0 (0) | 1 (6) | 1.0/1.0 |
| Fever (T > 100.4°F) | 0 (0) | 0 (0) | 0 (0) | 1.0/1.0 |
| Malaise | 3 (10) | 2 (7) | 0 (0) | 0.3/0.5 |
| Lightheadedness | 3 (10) | 3 (10) | 0 (0) | 0.3/0.3 |
| Headache | 5 (17) | 6 (19) | 3 (17) | 1.0/1.0 |
| Muscle aches | 1 (3) | 0 (0) | 1 (6) | 1.0/0.3 |
Volunteers ingested PTL-002 or PTL-003 in 200 ml of CeraVacx buffer. The placebo was CeraVacx buffer alone.
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.
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.
Vaccine recipients were compared to the placebo group by Fisher's exact test.
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.