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

ENABL adjuvants are regulatory-ready for use in poultry vaccines administered subcutaneously. Based on this study and other research, USDA approved the safety of three poultry 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 chickens (SQ)

 

Treatment Product

Route

Dose

No. of 
Birds

Age

Day

KIlled K99 (E coli) + ENABL

SQ, back of neck

0.2 mL

15

 Day of hatch

21

Killed K99 + phosphate-buffered saline (PBS)

SQ, back of neck

0.2 mL

15

 Day of hatch

21

 

  • 28 birds remained healthy and normal during 21-day observation
    • 3 were culled or died within the first 5 days (starve-out phase) due to unthriftiness
  • All injection sites were normal to direct palpation at all in-life observation times
  • At necropsy, gross pathology exams were normal
  • By histology exam
    • 15 of the 28 injection sites scored "normal"
    • 4 scored "minimal" (placebo)
    • 3 scored "mild" (1 was placebo)
    • 4 scored "moderate"
    • 2 scored "marked"
  • Histological findings were consistent to an expected physiological or immunological response upon injection of a foreign material