Cytomegalovirus Clinical Study
Austin Regional Clinic physicians constantly try to improve the care given to all our patients. We are dedicated to offering unique options for our patients and helping them reach their ideal health goals. Part of this dedication involves making clinical research available. Clinical research makes it possible to discover the benefits, risks, and safety of commercially available and investigational medications.
Research standards are very strict to help make studies as safe as possible. Teams of government and research experts have already reviewed each study we conduct to minimize any study risks. Austin Regional Clinic has decided to be involved in this research study because we believe it can potentially benefit our patients.
About the cytomegalovirus clinical study
Cytomegalovirus (CMV) is a leading cause of birth defects around the world. CMV is a common viral infection that usually goes unnoticed or only causes mild symptoms in most people. But if a woman becomes infected with CMV while she is pregnant, she can pass the infection to her unborn baby. This can cause her child to suffer long-term disability due to birth defects, including hearing loss, or even death in very severe cases. Currently, there is no approved vaccine against CMV.
CMV is the #1 infection that causes birth defects in the U.S. and one of the most common infectious causes of birth defects globally.
What to expect
The total length of participation in this clinical trial is approximately 2½ years (30 months).
- Clinical trial volunteers will have a screening visit to check whether they are eligible to participate. The visit includes a wellness exam, a review of your medical history, a urine pregnancy test for women, and some blood tests.
- During the first 7 months, trial participants will attend 5 in-person visits, including 3 vaccination visits where they'll receive injections in the upper arm.
- During the follow-up portion of the trial (Month 8 through month 30), participants will have in-person visits every 3 months and will provide updates via an eDiary, may be contacted by telephone, or may be requested to come in for unscheduled visits in between such visits.
- Each participant has a 50% chance of receiving the investigational vaccine and a 50% chance of receiving a placebo - like flipping a coin.
- You will be compensated for your time and for each visit you complete. Your clinical trial team can give you more details.
- We will schedule your visits in a way that minimizes disruption to your work and other commitments.
The investigational vaccine may help the body's immune system recognize and protect itself if it comes into contact with CMV in the future. You cannot become infected with CMV from receiving the investigational vaccine. The investigational vaccine in this trial, mRNA-1647, is a newer type of vaccine known as an mRNA vaccine.
Map: Every virus has signature features on its surface that can trigger your immune system. Once the features are mapped, an mRNA vaccine provides the blueprint to create the defense that can help your body protect itself if it encounters the virus.
Read: Once your body has the blueprint, it knows exactly what to do. It reads mRNA strands to build a defense by producing antibody proteins that are a lot like the answer key to a test. This means the next time your immune system encounters this type of virus, it already has the answer to help protect you.
Neutralize: Your body now knows how to neutralize the virus and is able to defend itself against the threat if it encounters the virus in the future. The message from the blueprint that was read is retained and recalled when needed. It's like remembering the answer from an old test without having to re-learn the material.
Activate: Moderna is developing mRNA vaccines, like the investigational vaccine mRNA-1647, that deliver blueprints to create the proteins that help activate immune responses against a variety of viruses.
This clinical trial is looking for volunteers. To join this clinical trial, you must be:
- Between 16-40 years of age
- In good health
- If you are a woman:
- In close contact with at least one child 5 years of age or younger for at least 8 hours a week, if age 20 or older
- Not pregnant and not planning on becoming pregnant within the next 9 months
Clinical trial staff will explain any additional requirements and answer any questions you or a loved one may have about participation. You may stop participating in the clinical trial at any time and do not have to give a reason for doing so.
If you are interested in this trial, call our ARC Clinical Research team at 512 225-5931.
Request to Participate