Informed Consent for Evaluating the Safety, Efficacy, and Immune Activities of EGFR/HER2 Tumor Vaccine In Canine Cancer Patients
1. Background and Purpose of Research
EGFR and HER2 proteins are overexpressed in canine (and human) malignancies and the overexpression is usually associated with poor prognosis. An experimental vaccine – EGFR/HER2 peptide vaccine – can induce EGFR/HER2-specific immune responsesand has been reported toextend survival times for some dogs with little to no side effects [1].
The purpose of this study is to evaluate the safety and efficacy of the vaccine in conjunction with conventional therapies such as surgery and chemotherapy, or radiation therapy. Canine patients who have relapsed after receiving standard of care therapy may also enroll in the study.
The study investigates the ability of dogs to develop anti-tumor immune responses and will collect data on survival times, efficacy, and adverse events or side-effects.
PLEASE NOTE: THE SAFETY AND EFFICACY OF THE EGFR/HER2 VACCINE IS NOT FULLY KNOWN.
2. Study Protocol / Procedure
The canine patient will receive two subcutaneous (under the skin) injections of the vaccine approximately 21 days apart. A small amount of blood will be collected at each time of the vaccination, and a final blood sample at day 40-50 after the start of vaccination therapy.
If the patient is undergoing surgery, a portion of the tumor removed may be collected and sent to the research team.
If possible, if the patient passes away due to progression of cancer or due to any other cause, we request that additional primary tumor sample or metastatic lesions be collected and shared with the research team. A full necropsy is not required but may be needed to harvest these tissues appropriately.
3. Side-Effects and Associated Risks
While adverse side effects are not anticipated, we will monitor your pet for any study-related discomforts. To date, approximately 600 dogs have received the vaccination therapy. A sterile abscesshas been observed at the injection site in about 20% of patients usually within 7-14 days of injection. (Swelling at the site of the vaccination with possible leaking fluids). This is caused by the inflammatory response of the body to the actual injection and is actually an encouraging sign of immune response. If there is any discomfort, additional pain medication may be prescribed, and warm compresses applied to help alleviate the swelling. The site heals usually within 10 days, although in some patient complete healing can take weeks to months.
Nonetheless, because the vaccine is a novel therapy, the total range of possible side effects and associated risks may not be fully appreciated. Hence, there may be finite risk associated with study participation, including patients experiencing thus far undocumented severe or life-threatening reactions, or death. The cost for treating complications will be incurred by the client (pet owner).
At any time, the clients may elect to pursue standard of care should the disease progress.
4. Expected Duration of Participation
The expected monitoring of study participation is 24 months. However, families may be contacted up to 3 years after enrollment to answer some survey questions.
5. Possible Benefits
The purpose of the study is to induce the generation of antibodies and other immune reactions against the tumor cells. The study will collect information on side effects both short term and long term, overall response rate to the vaccine and survival times compared to conventional therapies.
It is not known whether a specific canine patient will get any medical benefit, or reduction in tumor growth. However, based on the initial study described in [1], some patients receiving vaccination experienced an improved lifespan compared to receiving conventional therapies alone.
6. Compensation and Financial Obligations
The dog owners are responsible for costs of conventional treatment as well as for the required recheck visits as customary for conventional treatment and monitoring for the trial. The Yale EGFR/HER2 vaccine clinical trial is not funded, and there will be no financial compensation for participation in the study. The only financial benefit is that the vaccine is provided free of charge, but there are other visit-associated fees associated with each vaccine visit (including consultation/exam/data analysis fees, drug administration and biohazard fees, test fees involved in monitoring if done with VCCS). Pre-enrollment testing and monitoring at 3, 6, 9, and 12 months is also required, so the cost of testing will add up over time. The cost of each vaccine appointment with VCCS is $695, which is the responsibility of the client to pay at the time of the appointment. This does not include additional testing or treatment if needed.
7. Extent of Confidentiality of Records
The health information of all canine patients will be shared by the clinic with the collaborating research team. Also, individual patient and owner information will be redacted and not identified in reports nor publications that may be generated from this study. Health information will be shared with the USDA and is a requirement of 9 CFR 103.3. The canine patient will be identified to the USDA by an assigned code (not the owners name).
8. Contact
Questions about this research project may be directed to Prof. Mark Mamula at [email protected].
[1] Hester A. Doyle et al.,”Vaccine-induced ErbB (EGFR/HER2)-specific immunity in spontaneous canine cancer”, Translational Oncology, Volume 14, Issue 11,2021,
By signing below:
- I agree to enter my dog into this clinical trial to evaluate the safety and efficacy of the EGFR/HER2 Tumor Vaccine.
- I acknowledge that I have read and understand this consent form and all my questions have been answered to my satisfaction.
- I give permission for the data obtained from this clinical trial to be published for the benefit of the scientific community. I understand that no information will be published which would allow my pet to be individually identified.
- I understand that my dog’s participation in this study is entirely voluntary. I am free to withdraw my dog from this study at any time. Withdrawing from the study will not interfere with my dog’s cancer treatments or care. If my pet is unable to complete the follow up appointments as described, I will notify my pet’s oncologist ASAP
- I also understand that my dog may be withdrawn from the study by the clinician or the research team if deemed not in the best interest of the dog, or for violation of eligibility requirements, or noncompliance.
- I agree to be contacted by the research team post-treatment, and to answer follow up survey questions to the best of my ability.
- I have read and understand this consent form and I voluntarily consent to enroll my pet in this immunotherapy treatment program. I agree to participate in this study and will follow the instructions of the veterinarians in charge, as they pertain to therapy and follow‐up procedures.