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Evaluation of the Safety and Immune Responses of the Towne Strain of CMV in Seronegative Women

NCT00201448 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2016-05-30

Study results available
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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 daycare centers. Cytomegalovirus does not usually cause serious illness in adults and children. However, CMV can be a cause of deafness and mental retardation in a child born from a mother who has the infection during pregnancy. Women in the study will be given either cytomegalovirus or Hepatitis A vaccine. A blood sample will be taken before the vaccination is given. After vaccination, urine, saliva, and blood will be collected every 1-6 months for up to 3 years. Information regarding any reaction to the vaccination will be collected. All family members will be asked to provide urine and saliva to test for CMV every few months for up to 3 years. All children born to women who have been vaccinated will be tested for CMV infection. 180 women who are not infected with CMV will be vaccinated.

Conditions

  • Cytomegalovirus Infections

Interventions

BIOLOGICAL

Hepatitis A Vaccine

Single dose give IM

BIOLOGICAL

Towne CMV Vaccine

Single dose given subcutaneously

Sponsors & Collaborators

  • CMV Research Foundation Inc

    collaborator UNKNOWN

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Stuart Adler, M.D. · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00201448 on ClinicalTrials.gov