Introducing a research study for a potential mRNA shingles vaccine
The mRNA Shingles Vaccine Study will help us learn if an investigational vaccine is safe and can help the body produce antibodies which may help prevent shingles (also known as herpes zoster).
Who may participate
Participating in a clinical trial is an important and personal decision. Thank you for taking the time to learn more about the mRNA Shingles Vaccine Study.
This study is enrolling people who:
- Are 50 to 69 years old
- Are generally healthy or have stable chronic conditions
- Do not have a history of shingles or heart disease
- Have not previously received a chickenpox or shingles vaccine
- Have not had an RNA vaccine in the last month and do not plan to have an RNA vaccine within one month prior to receiving the study vaccine
There will be other study requirements that the study team will discuss with you.
Condition
Healthy volunteers
Age
50 to 69 years old
Sex
Male or Female
Each clinical study has its own guidelines for who can participate, called eligibility criteria. However, only the research study staff can determine if you qualify to enroll in the study.
Additional eligibility criteria
- Are generally healthy or have stable chronic conditions
- Do not have a history of shingles or heart disease
- Have not previously received a chickenpox or shingles vaccine
- Have not had an RNA vaccine in the last month and do not plan to have an RNA vaccine within one month prior to receiving the study vaccine
Get started — See if you may qualify
If you are considering participating in this study, answer a five-minute questionnaire about your health and medical history online. If your answers show the study might be a good fit for you, you may choose to be referred to a study clinic that you select.
You will then be asked to provide your contact information for a study representative to contact you and discuss the next steps. If you’re interested, they will do a more detailed review of your medical history to see if you are able to participate. Only the study staff can determine if you meet the study’s eligibility criteria and are able to enroll in the study.
Your answers to these initial questions will only be linked to you if your responses indicate that you may be eligible to participate in this study and you choose to share your contact information with the study team. Pfizer study team members and our partners will have access to reports containing aggregated data that will not be directly linked back to you.
What to expect
Study participants will be randomly placed into groups that will receive either the investigational shingles vaccine or a licensed shingles vaccine (comparator). Participants in the investigational shingles vaccine groups will receive one of three different candidates (which means it may be prepared differently) at one of three different dose levels.
The study vaccines will be given in two separate injections (shots) into the muscle in the upper arm. Participants will receive the second injection about two or six months after their first injection, depending on the group they are assigned.
Length of study treatment
Either about one or five years, depending on your study group
Number of study visits
Up to 17
Length of follow-up period
Up to five years, depending on your study group
About shingles
Shingles (also known as herpes zoster) is a viral infection caused by the varicella zoster virus (the same virus that causes chickenpox). After recovering from chickenpox, the virus stays in the body but is inactive. If it becomes active, it can lead to symptoms such as fever, and/or a painful rash.
Almost 1 in 3 adults in the United States will develop shingles in their lifetime. Anyone who has had chickenpox is at risk for shingles, but after 50 years of age, a person’s risk for shingles and shingles-related complications, such as long-term nerve pain or vision loss, greatly increases.
While vaccines have been developed to help prevent shingles, they aren’t always recommended for people with certain medical conditions (like a weakened immune system). That’s why we’re working to understand if an mRNA-based vaccine has the potential to be a safer option for the prevention of shingles.
Frequently asked questions
The investigational vaccine is a modified RNA (mRNA) vaccine, which does not contain any killed or weakened virus. mRNA vaccines work by telling your body to produce proteins that look just like certain parts of the virus. The immune system reacts to these proteins in a similar way to a real virus. As a result, certain immune system cells “remember” how to recognize these proteins quickly and fight the real infection if it happens in the future.
Investigational means that the vaccine we are researching has not yet been approved for use in patients with shingles.
This means it is not available to patients with this condition except to those who are participating in a study.
The study vaccines will be given in two separate injections (shots) into the muscle in the upper arm.
A research study that’s active-controlled uses a comparison (or control) group. Study participants will be randomly placed into groups that will receive either the investigational shingles vaccine or a licensed shingles vaccine (comparator). Participants in the investigational shingles vaccine groups will receive one of three different candidates (which means it may be prepared differently) at one of three different dose levels.
This means that participants and certain members of the study team will not know if the investigational shingles vaccine or the licensed shingles vaccine is being given. The person who prepares the injection will know which vaccine has been given, but they will not be able to talk to participants about it.
You will be assigned to a vaccination group by chance (like rolling dice) rather than by choice. This is called randomization and it is one way to help avoid bias in a study. The study team will explain more about the vaccination group you may be assigned.
