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Approved for safety & withdrawal

Not only is the manufacturing method in place for 15 ENABL™ adjuvants, but many also are ready for a regulatory safety review.

ENABL adjuvants are regulatory-ready for subcutaneous and intramuscular use in cattle, based on this withdrawal study and other research.

Treatment

Products

Route

Route

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 neck

2 mL

5

21

Killed K99 + PBS

SQ, left neck

4

Killed K99 + ENABL

SQ, left neck

2 mL

5

21

Killed K99 + PBS

SQ, right neck

  • 11 animals had nodules at 15 injection sites (10 at adjuvant site; 5 at placebo site); all but 1 cleared at Day 21
  • At necropsy, 6 sites with gross lesions: 4 at adjuvant SQ sites; 2 at placebo sites
  • Respiratory pneumonia became evident during study; all were treated with antibiotics
  • 1 death not attributable to inoculation at Day 3; 5 animals with elevated temperatures
  • By histology exam, skin and muscle (76 possible scores)
    • 65 normal
    • 7 scores (1 IM, 5 SQ) from adjuvant, rest from placebo
    • Part of the infiltration at the scored sites were typical of acute immune response recruitment; others were trauma due to physical damage

ENABL adjuvants are regulatory-ready for subcutaneous and intramuscular use in pigs, based on this withdrawal study and other research.

Treatment

Products

Route

Route

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)