Clinical trial NCT00125502 (phase 2, status: completed)
Conditions: cytomegalovirus infections
ICD codes: P35.1
Drugs: mf59 adjuvant, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  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.

          -  Cytomegalovirus (CMV) seronegative as determined by the Axsym® System CMV IgG antibody
             assay (Abbott Diagnostics) performed within 14 weeks prior to the first immunization.

          -  In good health as judged by medical history obtained by patient interview and physical
             examination.

          -  Willing to participate with 4 follow-up visits per year for 3 years after the third
             dose of vaccine.

          -  Volunteers must be willing to use an effective means of contraception of their choice
             from the first dose of vaccine up to 2 months after the third dose of the vaccine.

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

        Exclusion Criteria:

          -  Known maternal immune disorder such as HIV infection, collagen vascular disease,
             immune deficiency, or chronic disease requiring treatment with immunosuppressive
             medication.

          -  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 were allowed to enroll if they did not
        currently take medication for asthma and were off asthma medication and free from asthma
        symptoms for at least 2 years. Patients with mild to moderate essential hypertension on
        medication were allowed if their blood pressure was controlled within the normal range for
        at least one month.

          -  Positive rapid test for HIV antibody. All subjects were tested for HIV antibody using
             a rapid serologic test at the time of enrollment beginning with protocol version 1.7.
             Prior to that only subjects who had a history of a negative screening test for HIV
             during their most recent pregnancy were included. Subjects given HIV rapid serologic
             tests in this study were provided pre-test counseling before the test was performed
             and post-test counseling when the subject was 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. Subjects who
             are eligible for this study were 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.

          -  Maternal sterilization procedure planned in the postpartum period.

          -  Current use of steroids or other immunosuppressive medications.

          -  Maternal drug or alcohol abuse.

          -  Mothers who are nursing their infants.

          -  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.

          -  A history of anaphylaxis or serious vaccine reactions.

          -  Previous receipt of CMV vaccine.

          -  Receipt of blood products within 3 months prior to study enrollment.