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Withdrawal study supports USDA safety approval, 21-day withdrawal (SQ, IM)

ENABL adjuvants are regulatory-ready for use in swine vaccines administered subcutaneously and intramuscularly. Based on this study and other research, USDA approved the safety of five swine formulations with a 21-day withdrawal period — the shortest allowed by USDA and an especially important feature when developing vaccines for practical use.

 

                          Withdrawal study in pigs (SQ, IM)

 

Treatment

Products

Route

Dose

No. of Animals

Day

1

KIlled K99 (E coli) + ENABL

IM, right neck

2 mL

5

21

Killed K99 + phosphate-buffered saline (PBS)

IM, left neck

2

Killed K99 + ENABL

IM, left neck

2 mL

5

21

Killed K99 + PBS

IM, right neck

3

Killed K99 + ENABL

SQ, right inguinal

2 mL

5

21

Killed K99 + PBS

SQ, left inguinal

4

Killed K99 + ENABL

SQ, right inguinal

2 mL

5

21

Killed K99 + PBS

SQ, left inguinal

 

  • All animals remained healthy and normal during 21-day observation
  • No febrile response to injection was observed
  • All injection sites were normal to direct palpation at all in-life observation times
  • At necropsy, gross pathology exams were normal
  • By histology exam
    • 32 of the 40 injection sites scored "0"
    • 2 scored "mild" (1 was placebo)
    • 6 scored "minimal" (1 was placebo)