Evaluation of the Safety and Immune Responses of the Towne Strain of CMV in Seronegative Women
Cytomegalovirus Infections
About this trial
This is an interventional prevention trial for Cytomegalovirus Infections focused on measuring CMV, cytomegalovirus, vaccine, Towne strain
Eligibility Criteria
Inclusion Criteria: Women between 18 and 45 years of age Good general health without significant physical examination findings With children < 2 years old attending daycare centers Willingness to sign informed consent for screening and before enrollment Available to participate for the entire study period of 36 months Negative cytomegalovirus (CMV) serology Negative serum pregnancy test within two days prior to vaccination Willingness to have blood stored for future evaluations Willingness to have children provide saliva and urine samples Able to complete a demographic profile Agreement to practice effective contraception. Contraception is defined as using any of the following methods: Condoms (male or female) Diaphragm or cervical cap with spermicide Intrauterine device (IUD) Hormone contraception Abstinence Successful vasectomy in male partner Hysterectomy, bilateral oophorectomy, or tubal ligation Infertility confirmed by a gynecologist will also be acceptable Exclusion Criteria: Acute febrile illness (>/=38C / 100.4F) within 72 hours preceding the vaccination (vaccination may be deferred until febrile illness is resolved, but a repeat pregnancy test will be required if deferred more than 48 hours.) Positive pregnancy test Breastfeeding Venous access deemed inadequate for the phlebotomy demands of the study Receipt of any vaccine, blood products, or investigational agents within 30 days prior to enrollment History of serious adverse reactions to any vaccine, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema or abdominal pain History of immunodeficiency, autoimmune diseases, or malignancy History of severe cardiopulmonary diseases or serious metabolic disorders Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with history of psychosis within the past 3 years or history of suicidal attempt or gesture within the past 3 years Any acute or chronic condition (including alcohol or drug use) which in the opinion of the principle investigator would limit the volunteer's ability to complete the study
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Placebo (hepatitis A)
Towne vaccine
Placebo group
Towne vaccine given at 3000 pfu/subject