NOBIVAC® Edge Lepto 4

NOBIVAC EDGE^® Lepto₄ Vaccine

The only canine leptospirosis vaccine with two critical indications, available in 0.5 mL dose.

Product Description

NOBIVAC EDGE^® LEPTO₄ was shown to be effective against Leptospirosis in a 0.5 mL vaccine

The only 0.5 mL vaccine proven to protect against disease, mortality and leptospiruria.

Effective against 4 virulent Leptospira serovars²¹
The only vaccine proven to be effective against mortality and leptospiruria
Prevented leptospiremia²²
Protects against liver dysfunction and thrombocytopenia¹
Proven safe and well tolerated in multiple studies¹

product Label

Overview

Safety

Administration

Alternate

Disease Information

Indications:

Shown to be effective for vaccination of healthy dogs 8 weeks of age or older against Leptospira canicola, L. icterohaemorrhagiae, L. pomona and L. grippotyphosa.

Also been shown to be effective against mortality and leptospiruria (shedding of Leptospira in the urine) caused by L. canicola, L. icterohaemorrhagiae, L. pomona and L. grippotyphosa.

NOBIVAC EDGE^® LEPTO₄ IS A SAFE CHOICE

Safety confirmed in a 346-dog field study¹
Well tolerated on subcutaneous administration
Proven safe across a variety of breeds and ages
Featuring an even higher level of quality due to the VacciPure™ filtration

ADMINISTRATION AND DOSAGE

Subcutaneous injection
Two 0.5 mL doses given 2-4 weeks apart
Historically, annual revaccination has been recommended for this product. The need for this booster has not been established. Contact your veterinarian or manufacturer for more information on revaccination frequency.
Available in a 25 x 0.5 mL dose

ALSO AVAILABLE IN OTHER FORMULATIONS

DISEASE INFORMATION

Leptospirosis

Unmatched Protection of Nobivac EDGE^® Lepto₄: Two Critical Indications

1. SHEDDING: DEFENSE AGAINST URINARY SHEDDING CAUSED BY 4 KEY LEPTOSPIRA SEROVARS

PREVENT URINARY SHEDDING OF LEPTOSPIRES²²

A key objective of vaccination is to prevent urinary shedding of leptospires, which has potential zoonotic risk:^22,23

0% of dogs vaccinated with Nobivac® Canine 1-DAPPv+L4 developed leptospiruria
All of the control dogs challenged with L. canicola and L. grippotyphosa, 80% of control dogs challenged with L. icterohaemorrhagiae, and 50% of control dogs challenged with L. pomona developed leptospiruria

Nobivac^® Lepto₄ is shown to be effective against leptospiruria associated with

L. grippotyphosa
L. canicola
L. icterohaemorrhagiae
L. pomona

None of the dogs vaccinated with Nobivac® Canine 1- DAPPv+L₄ developed leptospiremia
100% of the control dogs challenged with L. canicola, L. grippotyphosa, L. icterohaemorrhagiae and 75% of the control dogs challenged with L. pomona showed leptospiremia, indicating the severe challenge model

2. MORTALITY: THE ONLY LEPTOSPIROSIS VACCINE SHOWN TO BE EFFECTIVE AGAINST DISEASE AND MORTALITY

PROTECTION FOR DOGS FACING THE MOST SEVERE CHALLENGES²¹

No dogs vaccinated with Nobivac® Canine 1-DAPPv+L₄ died or required euthanasia
54% mortality and euthanasia in control groups, reflecting the severity of challenge

Clinical efficacy results showed that Nobivac^® Canine 1-DAPPv+L₄ also prevented¹

Leptospiremia
- More than 85% of vaccinates had no leptospiremia; leptospires were cleared quickly from the blood in those that did
- By contrast, all control dogs had leptospiremia, and it lasted significantly longer, by days
Liver dysfunction
- Serum levels of bilirubin and AST* remained at normal levels in significantly more vaccinates
Thrombocytopenia
- Platelet counts remained in the normal range

* AST = aspartate aminotransferase

UNMATCHED PROTECTION

NOBIVAC^® LEPTO₄ IS THE CLEAR CHOICE WHEN COMPARED WITH OTHER 4-WAY LEPTOSPIROSIS VACCINES^24-27

VacciPure^™Filtration Technology

THE ADVANCED VACCIPURE™ FILTRATION TECHNOLOGY

FILTRATION PROCESS LEADS TO IMPROVED VACCINES¹

To promote an even higher level of quality and allow for 0.5-mL vaccines, Merck Animal Health introduced the unique VacciPure filtration process for manufacturing Nobivac EDGE^® Lepto₄, Nobivac EDGE^® DAPPV+L₄, Nobivac^® Lepto₄, and Nobivac^® Canine 1-DAPPV+L₄.

A porous filtration membrane selectively removes extraneous proteins, salts, and solvents
The outcome –

Fewer total proteins and a more purified product.
The ability to produce 0.5-mL vaccines that deliver full-sized protection at half the volume.

REDUCED TOTAL PROTEINS THROUGH VACCIPURE₁

Fewer total proteins (TP) means a more purified final product, which may reduce unwanted immune system responses, such as vaccine reactions.¹

Professional Resources and Educational Materials

Keep your clinic and staff informed and aware of diseases and outbreaks.

View More Nobivac Resources

SOP

AAHA Canine Vaccination Guidelines

In-depth information about canine vaccinations and veterinary best practices.

Download

EBook

Quick Guide to Lepto

A handy guide to protect dogs and prevent the spread of leptospirosis.

Download

Clinical Studies

Disease & Mortality Study

Read the study which proves high efficacy of Nobivac® Lepto₄ vaccine under severe challenge.

Prevention of Disease and Mortality in Vaccinated Dogs Following Experimental Challenge With Virulent Leptospira.

R LaFleur, J Dant, T Wasmoen. Intervet / Schering Plough Animal Health, Elkhorn, NE.

Canine Leptospirosis can vary from subclinical infection to illness that ranges from mild to severe, including death, depending on the susceptibility of the dog, virulence of the organism, and route and degree of infection. The objective of this study was to evaluate the ability of a canine Leptospira bacterin to prevent infection and disease following challenge with virulent Leptospira canicola, L. pomona, L. grippotyphosa, or L. icterohaemorrhagiae. Groups of 8-week-old beagles were vaccinated (day 0) and boosted (day 21) with placebo (n = 10) or the 4-way bacterin (n ≥ 20) and subsequently challenged with each serovar. The results demonstrated that blood and various tissue samples from placebo-recipients became reliably infected, and the dogs developed typical clinical signs of Leptospirosis including loss of appetite, ocular congestion, depression, dehydration, jaundice, hematuria, melena, vomiting, petechiae, and death. In addition, placebo-recipients developed kidney and liver dysfunction. In contrast, some vaccine-recipients became infected, but the organisms were cleared quickly from the blood. Vaccinated dogs failed to develop severe clinical disease requiring medical intervention, and no animals died (p > 0.001). A few of the vaccinated dogs developed clinical abnormalities, but the clinical signs remained mild and were self-limiting (p < 0.0001 for each serovar). Administration of the bacterin also prevented thrombocytopenia (p < 0.0001), kidney complications caused by L. canicola (p < 0.0001), L. icterohaemorrhagiae (p < 0.0001), and L. pomona (p = 0.012), and liver dysfunction caused by L. pomona (p < 0.0001) and L. grippotyphosa (p < 0.0001). The results therefore confirmed that vaccinating dogs with the 4-way Leptospira bacterin provided a high degree of protection (99.5%-100%) against the clinical signs of Leptospirosis including mortality.

Urinary Shedding Challenge Study

Read the study which proves Nobivac® Canine 1-DAPPv+L₄ effectively protects against leptospiremia and leptospiruria of (4) serovars.

Prevention of Leptospiremia and Leptospiruria Following Vaccination With a DAPPv + 4-way Leptospira Combination Vaccine

Rhonda L. LaFleur, Jennifer C. Dant, Anna L. Tubbs, Huchappa Jayappa, David Sutton, Ian Tarpey

Background: Leptospirosis, characterized by high fever, anorexia, vomiting, abdominal pain, diarrhea, myalgia, polyuria/polydipsia, jaundice, epistaxis, hematuria, and/or reproductive failure, continues to cause considerable morbidity among infected canines. Direct transmission of Leptospira spp. occurs when dogs come into contact with infected urine or ingest infected tissue. After dogs become infected, the spirochetes circulate in the blood for several days^1,3 where they cause extensive damage to the endothelium of small blood vessels (leptospiremia). After the leptospiremic phase, the spirochetes can further colonize various organs, including the kidneys, where dogs can become a carrier and potentially shed organisms in the urine for months (leptospiruria). Leptospira interrogans serovars Canicola and Icterohaemorrhagiae are traditional causative agents of canine leptospirosis, and while the use of bacterins have decreased the prevalence of the disease, significant morbidity can still be attributed to infection with these serovars.

Aim of the Work: In this study, we combined inactivated L interrogans serovars Canicola, Pomona, and Icterohaemorrhagiae and L kirschneri serovar Grippotyphosa with Nobivac^® Canine 1-DAPPv (Animal Health at Merck & Co., Inc., Kenilworth, NJ USA), a commercially available vaccine that contains modified live canine distemper virus, adenovirus, parainfluenza virus, and parvovirus. We then vaccinated dogs with the combination product and evaluated the ability of the vaccination to prevent leptospiremia and leptospiruria following challenge with viable organisms of each serovar.