Status:
TERMINATED
Evaluation of the Safety and Immune Responses of the Towne Strain of CMV in Seronegative Women
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
CMV Research Foundation Inc
Conditions:
Cytomegalovirus Infections
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of a vaccine given to women ages 18-45 to prevent cytomegalovirus (CMV), which they may catch from their children who attend dayca...
Detailed Description
This is a randomized, double-blind, placebo controlled, phase II-III trial conducted to assess safety and efficacy of the live attenuated Towne CMV vaccine in seronegative women who have children in d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00201448
Start Date
June 1 2007
End Date
October 1 2009
Last Update
May 30 2016
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298