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Read more below to learn about our phase 2 randomized, open-label, multisite trial to evaluate the immunogenicity of dose reduction strategies of the MVA-BN vaccine clinical trial investigating dosage strategies against monkeypox using the licensed Jynneos vaccine.
What is Monkeypox?
Monkeypox is a rare disease caused by infection with the monkeypox virus. Monkeypox virus is part of the same family of viruses as variola virus, the virus that causes smallpox. Monkeypox symptoms are similar to smallpox symptoms, but milder, and monkeypox is rarely fatal. Monkeypox is not related to chickenpox.
Purpose of our Study
The purpose of this research is to test different doses and routes of the MVA-BN Jynneos vaccine, IMVANEX®. Vaccines tell your germ-fighting cells to make antibodies and other substances to fight infections. All the study vaccines are intended to train the immune system so that if the person is then infected with the monkeypox virus, they have a “head start” and the infection can be stopped or made less severe.
Vaccination is being used in the current Monkeypox outbreak for known or presumed contacts. Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) is the one preferred and approved vaccine. Current FDA approved dose is two 0.5mL subcutaneous (SC) injections. However, there are limited supplies of this vaccine and dose sparing strategies have been suggested.
Eligibility Criteria
• You are between 18 and 50 years old
• Never received a licensed or investigational smallpox or monkeypox vaccine
• No history of monkeypox, cowpox, or vaccinia infection
• No close contact with anyone known to have monkeypox in the 3 weeks prior to enrollment
• Not Immunocompromised
• Not pregnant or breast feeding
What will happen during the study?
You will be asked to attend 8 in-person study visits, including an initial screening visit (that may be combined with the first study vaccination visit), two study vaccination visits, and 6 in-person follow-up visits. You may be asked to come in person if you get infected with monkeypox during the study. You will be in the study for up to approximately 12 months. Study visits may include a physical exam, and all will include a blood draw.
This study will be have three arms (groups) and will receive different doses and use different ways to give the vaccine:
• Intradermal (ID) injection just under the skin of the forearm
• Subcutaneous (SC) injection just under the skin into a fatty area on the arm
You will not be able to choose which group you are in. This will be randomly assigned (like flipping a coin).