Clinical Trial of mRNA Vaccine against Cytomegalovirus (CMV) in Youth Ages 9-15

Participants needed: Age 9-15

Please Note: The buttons above to learn more or live chat are not currently functioning. For more information on this study, please contact the study team via the information listed at the bottom of this page. 

 

What is the purpose of this study?

The purpose of this clinical trial is to evaluate the safety and effectiveness of mRNA-1647 vaccine for Cytomegalovirus (CMV). The use of a safe and effective vaccine may potentially prevent CMV infection. There is currently no approved vaccine to prevent CMV infection.

The main goals of this study are:

• To see if the study vaccine can prevent CMV infection in participants who have not been previously infected with CMV
• To understand the safety (side effects) of the study vaccine
• To see if the study vaccine results in participants making antibodies to CMV

About CMV

CMV is a leading cause of birth defects around the world and is the number one infection that causes birth defects in the U.S. 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 have long-term disability due to birth defects, including hearing loss, or even death in very severe cases. Currently, there is no approved vaccine against this devastating virus.

Who can join the clinical trial?

You can take part in this study if:

• You are between 9 and 15 years of age
• In good health
• Not pregnant or planning on becoming pregnant within the next 9 months

The clinical trial staff will explain additional requirements and can answer any questions that you may have.

 

About the Study Vaccine

Vaccines stimulate the body to make an immune response to parts of the virus, so that your body is better prepared to fight the virus if you come into contact with it. Typically, vaccines use a weakened or inactive version of the virus, a piece of protein from a virus, or a material that tells the body to make such proteins. The study vaccine is different. It is a messenger RNA (mRNA) vaccine. The mRNA is made entirely in a laboratory and instructs your body to make proteins like the ones found in CMV. Certain cells in your body recognize these proteins and cause your body to make antibodies to fight the virus if it enters your body in the future.

The study vaccine is not made from CMV and cannot cause infection. The study vaccine breaks down naturally and does not stay in your body.

The vaccine being studied, mRNA-1647, is an investigational vaccine. An investigational vaccine is not yet approved by any regulatory agency, such as Health Canada, the United States Food and Drug Administration (FDA), or Medicines and Healthcare products Regulatory Agency (MHRA). It can only be used in a study like this one.

What to expect

This study has 12 clinic visits and approximately 11 safety telephone calls over approximately 18 months. There are 3 study injections in the first 6 months.

• Clinical trial volunteers will have a screening visit to check whether they are eligible to participate.
• The visit includes a wellness exam, review of your medical history, a pregnancy test, and some blood tests
• Participation involves a total of 12 scheduled visits, and you will receive 11 phone calls/safety calls:
  • You will be contacted for health information check-ups either by telephone, text message, email, or through an electronic diary (eDiary) application (app)
  • You will receive an injection on Day 1, Month 2, and Month 6 (Day 1, Day 57 and Day 169). You will need to stay at the study site for about 30 minutes after you receive the injection so that the study staff can see whether you have any immediate reactions to the injection.
  • There will be a site visit 7 days after and then 4 weeks after the third injection. After that, you will receive a safety phone call every 4 weeks from the study staff.
• All Stage 1 participants will receive the study vaccine. Stage 2 and 3 participants will be randomly assigned to either receive the clinical trial vaccine or a saltwater placebo.

You will receive up to a total of $2325.00 if you complete all study visits.

 

Contact:

Krystal Lariviere, Research Coordinator

Phone: 902-470-6574
Email: Krystal.Lariviere@iwk.nshealth.ca