Specific aims will test the ability of CMV gB/MF59 vaccine to prevent maternal infection, evaluate the rate of congenital CMV infection in offspring of trial participants, and determine whether maternal CMV infection is associated with miscarriage.

Condition	Intervention	Phase
Cytomegalovirus Infections	Vaccine: CMV gB vaccine  Vaccine: adjuvant combination MF59	Phase II

Further Study Details: 

Expected Total Enrollment:  444

This clinical trial will test the efficacy of CMV glycoprotein B (gB) vaccine (Aventis Pasteur) with MF59 adjuvant (Chiron Vaccines) to prevent maternal CMV infection, using a phase II, randomized, placebo controlled, double-blind clinical trial. Healthy young postpartum women are screened for antibody to CMV. Only seronegative women are included in the clinical trial. Participants will be given 3 doses of vaccine and followed up every 3 months for three years after the third dose.

Ages Eligible for Study:  14 Years   -   40 Years,  Genders Eligible for Study:  Female

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1. Mothers, 14 to 40 years of age (inclusive), who have delivered a newborn infant within the previous 12 months, reside within the Birmingham metropolitan area, or the Tuscaloosa county area, and sign an informed consent form following a detailed explanation of the study. 2. CMV seronegative as determined by the Axsym� System CMV IgG antibody assay (Abbott Diagnostics) performed within 14 weeks prior to the first immunization. 3. In good health as judged by medical history obtained by patient interview and physical examination. 4. Willing to participate with 4 follow-up visits per year for 3 years after the third dose of vaccine. 5. Volunteers must be willing to use an effective means of contraceptive of their choice from the first dose of vaccine up to 2 months after the third dose of the vaccine.

Methods that will be considered effective for the purposes of this clinical trial include any hormonal contraceptive, double barrier methods and abstinence.

Exclusion Criteria:

1. Known maternal immune disorder such as HIV infection, collagen vascular disease, immune deficiency, or chronic disease requiring treatment with immunosuppressive medication. 2. Chronic disease such as diabetes, sickle cell disease, heart disease, fibromyalgia, arthritis or asthma requiring medication.

Patients with a diagnosis of asthma or past asthma will be allowed to enroll if they do not currently take medication for asthma and have been off asthma medication and free from asthma symptoms for at least 2 years. Patients with mild to moderate essential hypertension on medication will be allowed if their blood pressure is controlled within the normal range for at least one month.

3. Positive rapid test for HIV antibody.

All subjects will be tested for HIV antibody using a rapid serologic test at the time of enrollment. Subjects will be provided pre-test counseling before the test is performed and post-test counseling when the subject is informed of the test results. This counseling is provided by the study nurses according to CDC guidelines [Centers for Disease Control and Prevention. Revised Guidelines for HIV Counseling. Testing and Referral and Revised Recommendations for HIV Screening of Pregnant Women. MMWR 2001: 50 (No. RR-19)]. Subjects who are eligible for this study are considered very unlikely to be HIV positive because almost all adults who are HIV positive are also CMV positive and almost all potential enrollees will have received HIV screening during their recent pregnancy. If a subject is found to be HIV positive, she will receive post-test counseling and referred to a HIV medical care provider.

4. Maternal sterilization procedure planned in the postpartum period. 5. Current use of steroids or other immunosuppressive medications. 6. Maternal drug or alcohol abuse. 7. Mothers who are nursing their infants. 8. Participation in a clinical trial of another investigational vaccine or drug, if they have received the investigational drug or vaccine within 6 months prior to enrollment date for this trial. 9. A history of anaphylaxis or serious vaccine reactions. 10. Previous receipt of CMV vaccine. 11. Receipt of blood products within 3 months prior to study enrollment.

Please refer to this study by ClinicalTrials.gov identifier  NCT00125502

Robert Pass, MD      (205) 996-7790 

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  35233,  United States; Recruiting
      University of Alabama at Tuscaloosa, Tuscaloosa,  Alabama,  35487,  United States; Recruiting

Study ID Numbers:  99-038
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125502
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02