What is the study vaccine?
This study is testing a vaccine to see if it can prevent cytomegalovirus (CMV) infection in women 16 to 35 years old who may eventually have children. The V160 vaccine is not approved by the United States Food and Drug Administration (FDA).
Not everyone who volunteers for this study will receive the V160 vaccine. Some study volunteers will get a placebo instead. Both the V160 study vaccine and placebo are injections, but the placebo contains a saline solution with no active medicine.
Who can participate in the study?
You may qualify if you:
- Are a woman between the ages of 16 and 35 years old
- Are around children 5 years old or younger at home or work
- Are not currently pregnant
There are additional requirements that the study doctor will discuss with you.
What will happen if I join the study?
Before you can join, the study doctor will discuss the study with you. You will also read and sign an Informed Consent Form (ICF). This document will give you details about the study and explain the risks and benefits of participation. You can ask the study doctor and staff as many questions as you want about the study before signing this form.
If you decide to join the study, you will first need to have some medical tests to see if you are a good fit to participate in this study.
There are three parts in the study: the screening period, the treatment period, and the follow-up period. During the screening period, the study doctor will make sure you meet the study criteria and are a good candidate for this study. If you are eligible and choose to enroll, the total amount of time you spend in the study and the exact number of visits you have during the treatment and follow-up periods will depend on when you join the study. Before you agree to volunteer, you should understand what will be required of you during the study.
What will I need to do in this study?
You will need to visit your study site three times for injections of study vaccine or placebo and up to six more times for follow-up. You will also need to collect and send samples of your saliva and urine each month to test for CMV. The study doctor will explain how to collect your samples. You may need to come in for more study visits if you become pregnant during the study. You should review the ICF, which will explain everything that will be expected of you during this study.