Hanid Audish and Encompass Clinical Research Begin New HPV Vaccine Study
Dr. Hanid Audish and Encompass Clinical Research will begin a new clinical trial to study the effective dosing needed for a vaccine manufactured by Merck called Gardasil 9. Gardasil 9 is currently available to help fight human papillomavirus (HPV) infection in people ages 9-45.
HPV is known to cause cervical, vaginal and vulvar cancers in women. It also causes certain throat and back-of-the mouth cancers and genital warts in both men and women.
Dr. Hanid Audish and Encompass Clinical Research will study the immune response to the vaccine Gardasil 9 and whether two doses of Gardasil 9 will be sufficient to prevent HPV as compared to the current Food and Drug Administration (FDA) approved three-dose course. This study will test the safety and effectiveness of the vaccine when it is given with different amounts of time between doses.
Researchers will look at the immune response to the trial vaccine depending on the length of time between doses. Once completed, the trial results will be shared with the FDA to see if it meets their standards.
Hanid Audish and Encompass Clinical Research is currently enrolling women ages 16-26 who are in good health, have never had an HPV vaccine before and will agree to the requirements of the study. Participants and their parents/guardians will agree to attend all study center visits, comply with the study procedures and agree to be contacted by study staff during the study.
Study enrollee’s healthcare insurance will be responsible for covering the costs the standard care, but the study will pay for the study vaccine cost and the costs of related tests.
This study is a Stage 3 Clinical Trial which means the study will compare the new treatment with the current standard of care treatment. Clinical trials and all of the people who took part in them are behind every medication in your pharmacy today as well as treatments to cure and prevent diseases. Clinical trials allow improvements in healthcare to happen, as researchers and doctors study the safety and efficacy of new drugs along with expanding the various uses of existing drugs.
Clinical studies follow rules designed to protect the safety of study participants. An Institutional Review Board (IRB) monitors all studies to make sure the rules are followed. IRB members include doctors and people from other professions, such as teachers and religious leaders. The ethical and legal codes that govern medical practice also apply to studies.