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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 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

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

When cattle were inoculated intramuscularly with an adenovectored foot-and-mouth disease vaccine including ENABL, they had higher rates of protection with low relative virus titers — even when extremely low doses were used.