Are you interested in advancing research on women’s health?
Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause infection. There are many different types of HPV.
A standard vaccine to prevent HPV-related cancers is V503. V503 protects against 9 types of HPV. V540A is a study vaccine designed to protect against the same (shared) 9 HPV types plus other (unique) HPV types.
Researchers want to learn if V540A:
- Is safe and if people tolerate it
- Works as well as V503 to cause an immune response (the body’s response to protect against infections and illnesses) to the shared HPV types.
Would you like to take part?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your health to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to other women at risk of contracting HPV, and whether it will be made widely available to all Canadian women trying to manage this condition. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are in good health
- Have a lifetime history of 0 to 4 sexual partners of any sex/gender
- Are a participant assigned female sex at birth, and are not breastfeeding during the study intervention period and for at least 30 days after the last dose of study intervention
You may not qualify to participate if you:
- Have a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that has required medical intervention
- Have a known history of functional or anatomic asplenia
- Are currently immunocompromised or have been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
- Have thrombocytopenia or other coagulation disorders
- Have had a positive test for human papillomavirus (HPV)
- Have a history of recurrent respiratory papillomatosis or HPV-related head and neck cancer, or HPV-related anal lesions or anal cancer
- Have a history of an abnormal cervical biopsy result
- Have a history of HPV-related external genital lesions or external genital cancer, HPV-related vaginal lesions or vaginal cancer
- Have received a dose of any HPV vaccine before study entry
- Have received within 12 months before the Day 1 vaccination, are receiving, or plan to receive during the study, immunosuppressive therapies or other therapy known to interfere with the immune response
- Are currently receiving systemic steroid therapy or have received 2 or more courses of high-dose corticosteroids lasting at least 1 week in duration in the year prior to Day 1 vaccination
- Have received within the 3 months before the Day 1 vaccination, is receiving, or plans to receive during the study any immune globulin product
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.
