Healthy Female Volunteers 16-35 - Valley Village CA

Summary:

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Cytomegalovirus (CMV) is a virus that can infect people of all ages. Most people never have symptoms of CMV. This is because a healthy person’s immunesystem can usually fight offthe virus. However, the virus can cause health problems for some babies whose mothers become infected with CMV while they are pregnant.

What is the purpose of the study?

• The V160-002 study is testing a vaccine to see if it can prevent CMV infection in women who have not already been infected with CMV. This study is also testing how your body handles the vaccine, and if the vaccine is safe.

What is the study vaccine?

• This study is testing a vaccine called V160. Researchers are testing the safety of the vaccine and how well it works to prevent CMV infection in women who may eventually have children. Most babies born with CMV don’t have any symptoms. However, CMV can cause health problems at birth in some babies.

These can include:

• vision problems
• hearing problems
• issues with the nervous system

Even babies who have no CMV symptoms when they are born can develop hearing loss when they get older

A vaccine to prevent women from getting a CMV infection may be able to stop the spread of CMV from mothers to babies. 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 volunteers will get a placebo. Both the V160 study vaccine and placebo are injections, but the placebo contains no medicine. Using a placebo may let researchers learn more about how well the study vaccine works. 

Qualified Participants Must:

• Be a woman between the ages of 16 and 35 years old
• Around children 5 years old and younger at home or work
• Not currently pregnant
*There are additional eligibility criteria that the study doctor will discuss with you.

Qualified Participants May Receive:

What will happen if I join the study?

• Before you can join, the study doctor will tell you a little more about the study. You will also read and sign an Informed Consent Form (ICF). This document will tell you everything that will happen in the study. 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 and assessments to see if you are a good fit to participate in this study.

What will I need to do in this study?

• You will need to visit your study site 3 times for injections of study vaccine or placebo and up to 4 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.

Study Stipend:

• You will get $100.00 for each study clinic visit you complete to help cover the cost of travel and
  expenses (which may include such things as parking, baby-sitting, time off from work, meals,
  etc.).
• You will get $25.00 for all self-collections (urine and saliva) you provide.
• If you do not finish the study, you will only be paid for the visits you
  completed.