Form A: Information sheet for dog owners (English version)
Form B: Owner / dog details and initial clinical examination
Form C: Recording sheet for baseline clinical examination (before vaccination)
Form D: Daily recording sheet for clinical examination (1-4 days post vaccine)
Form E: Record of veterinary treatments
Form A: Information sheet for dog owners (English Version)
Vaccine trial againstLeishmaniain dogs
The University of Crete and two UK research establishments (The University of Warwick and the Cambridge Institute for Medical Research) are testing a potential canine vaccine to protect dogs and humans against leishmaniasis. There are no vaccines widely available against leishmaniasis despite it causing serious illness in both dogs and humans. The novel vaccine that we wish to test has been shown to be protective in laboratory conditions in mice and dogs. Therefore it is an exciting development and we hope it to be the first fully proven canine vaccine against leishmaniasis.
The first phase of the vaccine trial is to test the vaccine in a small number of dogs that are kept under close observation by us in kennels. This requires enrolling young healthy dogs from villages where leishmaniasis is endemic Only on completion of these trials will we be able to proceed to the second phase of the project which is to test the vaccine in a larger number of dogs in endemic villages to evaluate its efficacy in reducing the canine disease. Below are answers to your questions. If you have any doubts please contact:
Maria Antoniou, Laboratory of Clinical Bacteriology, Parasitology, Zoonoses and Geographical Medicine, Faculty of Medicine, University of Crete, Voutes, Heraklion, Crete 71003, Greece. Telephone: 00 30 2810 394 746.
Your Questions
What is the aim of the first Phase of the trial?
The trial will be carried out in kennels at the University of Crete to show that the vaccine induces the immunological responses known to be important in protecting mice, dogs and humans against leishmaniasis. It will also confirm that the vaccine causes no side effects. Dogs will not be artificially (or naturally) infected with
How safe is the vaccine?
Different components of the vaccine have been previously tested in mice, dogs and primates without any adverse side effects. The vehicle component of the vaccine is widely used in human vaccines and has been rigorously tested for safety. We do not expect any side effects resulting from the vaccine. However, as for the common human vaccines, we cannot say that the risk of side effects is absolutely zero. The most we would expect is a temporary inflammation in the skin at the site of the inoculation for a few days (as occurs in some human vaccines).
What will be required of my dog?
If you agree for your dog to be recruited into the trial, we will first take a blood sample to check that it has not been previously infected withLeishmania. If it is negative, then it can be recruited into the trial. The dog will need to stay with us in our kennels for 4 months during which time it will be monitored by our trained veterinarians. At the end of the 4 months your dog will be returned to you without harm.
What will happen to my dog?
If your dog is recruited, we will first ask you to bring the dog to stay in the kennels overnight on a number of occasions for it to become accustomed. The kennels are brand new and built larger than the EEC ethical recommendations for keeping dogs in kennels. Dogs will have an outside run (largely shaded) with a dog house in which to sleep. Food and water adlib will be provided appropriately, and dogs will be checked by our resident trained animal carer, and also checked daily by our veterinarian. It is in our interest to keep your dog as happy and as healthy as possible.
Why does my dog have to stay in the kennel?
Your dog will need to remain with us for approximately 4 months to allow it to fully develop an immunological response to the vaccine. We can only judge the effectiveness of the vaccine if we can follow-up the dog for the full 4 months in a controlled environment, where we can monitor its health carefully and prevent any exposure to infection.
How will the dog be treated?
If not already vaccinated, dogs will be first vaccinated against Distemper, Parvovirus, Hepatitis, Leptospirosis and Parainfluenza virus, and wormed against roundworms, tapeworms and hookworms. It will also receive a full veterinarian clinical examination. After about two weeks, the dog will be inoculated with either the
Leishmaniavaccine or a placebo (for comparison), and a blood sample taken every 2-4 weeks to test for immunological responses. A veterinarian will physically inspect the dog on a daily basis to ensure all is well. The dog will wear an insecticidal collar with proven activity against sandflies to protect it against any potential infection, and we will monitor the area round the kennels using traps to confirm that the area is free of sandflies.
Can any dog be recruited into the trial?
We are looking to recruit dogs that have not been previously exposed to Leishmania. This is more likely for dogs >4 months and≤24 months old. To ensure that the dog has not been exposed to the parasite, we will collect a small blood sample to test for
Leishmania. Dogs less than 4 months old are excluded from the trial because their immune systems are not fully developed and therefore would give results that are difficult to interpret.
If I agree what are my obligations?
If you agree, then we would expect you to permit the dog to stay with us for the entire 4 months so that the study can provide the results necessary to prove that the vaccine produces the appropriate responses. To avoid excessive disruption and stress which may affect the results of the trial and upset other dogs in the kennels we would ask owners not to visit their dog after the initial introduction period, however you are free to contact us at anytime to enquire regarding the dogs well being. At the end of the 4 months you should accept the return of your dog in good health. You accept that there will be no form of payment for the temporary loan of your dog.
What will happen next?
Informed written consent will be obtained from you at the time of recruitment, and we will contact you concerning arrangements to visit the kennels.
Form B : Owner / dog details and initial clinical examination Owner details Name……… Address……… ……… Telephone…..……….……. Dog details Dog ID reference number…………
Dog’s name……… Breed……… Age (months) ……….. Sex……… Neutered YES NO Previous vaccinations: Date Distemper …….. Hepatitis …….. Parvovirus …….. Parainfluenza virus …….. Leptospirosis …….. Rabies …….. Medical history Condition Date Clinical examination Body weight ……….. kg Condition score (please circle): 1 2 3 4 5 Thin Fat Body temperature………
Are any clinical signs ofLeishmaniapresent? Yes / No Clinical signs……….……….
Are any other signs of illness present? Yes / No Clinical signs ……….
Signature of examiner ……….
Laboratory Test Results: ELISA IFAT PCR Declaration: I agree to lend my dog to the University of Crete for the purposes described in the Information Sheet which I have fully read and understood, and will comply with the obligations as the owner of the dog as described in the Information Sheet. Signed………
Form C: Recording sheet for clinical examination (Days 0, 28, 42, 70, 98, 126)
Dog ID……… Examination day: 0 28 42
70 98 126 Body weight: ……….. kg Condition score: 1 2 3 4 5 Thin Fat Body temperature……… Pulse: ……….. Resp. rate……….
Capillary refill time………..
Mucous membrane colour……….
Are any clinical signs ofLeishmaniapresent Yes / No Description of clinical signs……….….
………
Are any other signs of illness present? Yes / No Description of clinical signs………
………
Form D: Daily recording sheet for clinical exam: Days 1-4 post vaccination
Dog ID:……….. Date of vaccine: …………
Signature of Examiner…………
DAY 1 post vaccine: Temperature:………
Pulse: ………
Resp. rate………
Capillary refill time………
Mucous membrane colour……….
Local swelling at injection site Yes / No Local pain at injection site Yes / No Alopecia at injection site Yes / No Generalized urticaria Yes / No Clinical signs observed:………
………
DAY 2 post vaccine: Temperature:………
Pulse: ………
Resp. rate………
Capillary refill time………
Mucous membrane colour……….
Local swelling at injection site Yes / No Local pain at injection site Yes / No Alopecia at injection site Yes / No Generalized urticaria Yes / No Clinical signs observed:………
………
DAY 3 post vaccine: Temperature:………
Pulse: ………
Resp. rate………
Capillary refill time………
Mucous membrane colour……….
Local swelling at injection site Yes / No Local pain at injection site Yes / No Alopecia at injection site Yes / No Generalized urticaria Yes / No Clinical signs observed:………
………DAY 4 post vaccine: Temperature:………
Pulse: ………
Resp. rate………
Capillary refill time………
Mucous membrane colour……….
Local swelling at injection site Yes / No Local pain at injection site Yes / No Alopecia at injection site Yes / No Generalized urticaria Yes / No Clinical signs observed:………
Form E: Record of veterinary treatments
Dog ID:………
Date:………
Reason for treatment:………
………..
Name(s) of Veterinary product(s) used:………
………..………
………..………
How many times was treatment given?………..
How many days was treatment given for?...
Form F: Record of Adverse Event
Definition: An Adverse Event is any observation in the trial dogs that is unfavourable and unintended, which occurs after the use of the experimental vaccine, whether or not it is considered to be related to the vaccine.
Dog ID:………
Letter code ofLeishmaniavaccine administered……….
DateLeishmaniavaccine administered: ………
Date and time of Adverse event:……….
Description of Adverse Event……….
………
………
………
Duration of Adverse event:………..………
Action taken:………..………..……….
Signature of person recording Adverse Event………