Join the fight against Monkey pox outbreak
Consider joining The POX-MVA-046 Study evaluating a new method to speed up Monkey pox vaccine production and improve access during outbreaks.
See if you are eligible
Mpox (formerly known as monkeypox) is a virus similar to smallpox that has been spreading globally in recent years. A safe and effective vaccine has been approved and is used to help control mpox outbreaks, including the one in 2022-2023. While the current method of making the vaccine works well, there are limits on how quickly and how much vaccine can be produced.
The POX-MVA-046 Study is evaluating a potential newer method that may make it faster and easier to produce large quantities of the vaccine – especially if needed during public health emergencies and when demand increases. The approach may also make it easier to share vaccine production with other manufacturers around to world, helping to improve vaccine access and supply during outbreaks.
The POX-MVA-046 Study is comparing how the immune system responds to 2 versions of the same vaccine made in different ways. Both versions of the vaccine being used in this study have been made according to strict quality standards.
Why join the study?
If you decide to join, you will:
• Receive either the mpox vaccine, made by the current production method or a test vaccine made by the method being evaluated
• Receive close care and monitoring at no cost
• Contribute to research: help us ensure that important vaccines remain accessible and reliable, especially in the event of future outbreaks
• Receive compensation for time and travel
You may be able to join if you:
- Are 18 to 49 years old
- Are in general good health, without clinically relevant medical illness
- Do not have, or previously had, autoimmune disease or immunodeficiency syndrome
- Have not previously received a smallpox or mpox vaccine
- Have no history of mpox infection
- You will need to meet other requirements to join the POX-MVA-046 Study.
Participation in the POX-MVA-046 Study includes:
- Screening: Up to 28 days
- Active study period: 35 days
- Follow-up period: 6 months
After a screening period to confirm medical eligibility, participants will be randomly selected (as if by flipping a coin) to receive either the smallpox/mpox vaccine made using the current production method or the study vaccine made by the method being tested.
Participants will attend only 7-8 study visits where they will receive 2 vaccinations, 4 weeks apart, with 6 months of follow-up after the second vaccination. The vaccines are given as a shot under the skin.
Mpox is a disease caused by the pox virus. It is related to smallpox, a disease that no longer occurs anywhere in the world. Both adults and children can get mpox if they have close contact with an infected animal, person, or that person’s clothing or bedding. Mpox causes fever, headache and muscle aches, swollen glands, and a rash that can look like pimples or blisters.
In the mpox outbreak in 2022-2023, death was rare; it only occurred in about 1 in 1,000 cases.
There is no specific treatment for mpox, but treatment to manage symptoms can help. Antiviral drugs may be given to people who are at risk for severe disease. However, it may be better to prevent mpox with a vaccine.
A clinical research study (also sometimes called a clinical trial) is carefully supervised research that follows specific rules to protect the rights, safety, well-being, and privacy of participants.
The POX-MVA-046 Study is comparing how the immune system responds to versions of the vaccine made in different ways. Clinical studies like the POX-MVA-046 Study help ensure that important vaccines remain accessible and reliable, especially in the event of future outbreaks.
Studies like POX-MVA-046 Study play a vital role in helping to improve public health and prepare for future health emergencies.
Frequently asked questions
The POX-MVA-046 Study is comparing how the immune system responds to versions of the vaccine made in different ways.
Participation in the POX-MVA-046 Study includes:
- Screening: Up to 28 days
- Active study period: 35 days
- Follow-up period: 6 months
After screening, participants will be randomly selected (as if by flipping a coin) to receive the smallpox/mpox vaccine made by using either the current production method or the method being evaluated.
Participants will attend 7-8 study visits. They will receive 2 vaccinations, 4 weeks apart, with 6 months of follow-up after the second vaccination. The vaccines are given as an injection under the skin.
You may not directly benefit from taking part in the POX-MVA-046 Study, but your participation will help us learn how the immune system responds to the mpox vaccine when it is produced in a new way.
If you decide to join, you will:
- Have a 50% chance of an approved smallpox/mpox vaccine, 50% chance of a study vaccine
- Receive study-related care at no cost
- Receive compensation for time and travel
- Contribute to research: help us ensure that important vaccines remain accessible and reliable, especially in the event of future outbreaks
Like all medications and vaccines, the study vaccine may cause side effects, although not everyone gets them.
The potential risks associated with the study vaccine may include:
- Symptoms at the injection site, such as pain, redness, or swelling
- People also frequently (more than 30%) reported general symptoms such as tiredness, headache, and muscle aches
- Serious side effects possibly related to the vaccine have been very rare (less than 0.1%).
No, you cannot get mpox from the vaccine. It contains a type of pox virus that cannot grow in the human body.
During a clinical study, you’ll receive either the mpox vaccine made by the approved method or the vaccine made by the method being tested. This will be done at scheduled times. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams or other types of assessments that are necessary to gather the required information about the study medication. All study volunteers are always closely monitored by clinic staff and the medical team to help protect their safety.
Participation in any clinical study is completely voluntary. Your decision to participate—or not participate—in this clinical study will have no effect on the medical care that you receive now or in the future. If you are eligible and choose to take part in the study, you may leave the clinical study at any time, and for any reason.
Bavarian Nordic (who is conducting this clinical trial) will reimburse all study participants for study-related travel and expenses. For more information, please speak with a member of the study team during your study visits.
You’ll first be asked some general questions (here) that help us determine whether you meet the basic criteria of the study. If you do meet this criteria, you may be asked to come in for a study visit. At that visit, you’ll be screened to see if you fit the specific qualifications for the study.
There are many reasons to participate in clinical research. It may allow participants to play a more proactive role in their own health by receiving a potential new treatment or vaccine for a disease or condition. In the POX-MVA-046 Study, participants may also play an important part in improving public health, possibly benefiting thousands of people by helping to ensure that vaccines remain accessible, reliable, and timely. In many cases, this can be life changing. Finally, participants may be paid for their time and travel expenses.
Every clinical trial must be reviewed, and is continually monitored, by an ethics committee to ensure the risks are as low as possible and are worth any potential benefits to the study participant. As a volunteer, you have the right to leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled.
Bavarian Nordic is responsible for conducting this study.
